Australian regulatory guidelines for

medical devices
(ARGMD) Part 3Post-market

Version 1.1, May 2011

Therapeutic Goods Administration

About the Therapeutic Goods Administration (TGA)

The TGA is a division of the Australian Government Department of Health and Ageing, and is
responsible for regulating medicines and medical devices.
TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk-management
approach designed to ensure therapeutic goods supplied in Australia meet acceptable
standards of quality, safety, and efficacy (performance), when necessary.

The work of the TGA is based on applying scientific and clinical expertise to decision-making, to
ensure that the benefits to consumers outweigh any risks associated with the use of medicines
and medical devices.
The TGA relies on the public, healthcare professionals, and industry to report problems with
medicines or medical devices. TGA investigates reports received by it to determine any
necessary regulatory action.

To report a problem with a medicine or medical device, please see the information on the TGA
website.

Copyright
Commonwealth of Australia 2011

This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any
process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights
should be addressed to the Commonwealth Copyright Administration, Attorney Generals Department, National Circuit, Barton
ACT 2600 or posted at http://www.ag.gov.au/cca

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Therapeutic Goods Administration

Version history
Version

Description of change

Effective date

V1.0

Initial publication

28/04/10

V1.1

04/05/11

Updated references and contact details to reflect TGAs new

organisational structure post TGA21

Made multiple amendments and additions in Section 3. Essential

Principles, Principle 14Clinical Evidence.

Made multiple amendments in Section 22. Post-market vigilance

and monitoring requirements.
Added a fourth part titled Navigation and Reference that
includes:

a bibliography
consolidated contact details
an index
a glossary of terms

Made various punctuation and grammar amendments

Reformatted for compliance with new TGA style manual

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Therapeutic Goods Administration

Contents
Part 3Post-market

292

Section 21. Changes to ARTG Inclusions

293

Section 22. Post-market vigilance and monitoring

requirements

294

Overview ___________________________________________________________________ 294

Sponsors ongoing responsibilities _____________________________________ 294
Distribution records ___________________________________________________________________ 297
Annual reports of problemsClass III, Class AIMD and implantable Class IIb
medical devices ________________________________________________________________________ 297

What the sponsor should include in the annual report _____________ 299

Manufacturers ongoing obligations ___________________________________ 300

Ongoing monitoring of compliance by the TGA ______________________ 301

Post-market reviews for medical devices ____________________________________________ 302

Vigilance ____________________________________________________________________ 304

Vigilance exchange _____________________________________________________________________ 304

Who is notified when there is an issue with a medical device? _____________________ 305

Reportable adverse events ______________________________________________ 305

Reporting incidents with medical devices ___________________________________________ 306

Exemptions from reporting adverse events to the TGA _____________________________ 308

Timeframes for submitting adverse event reports to the TGA _____________________ 312

Details to be included in an adverse event report ___________________________________ 312

Access to medical devices involved in adverse events ______________________________ 314
What the TGA does when it receives an adverse event report _____________________ 315
TGA testing of devices _________________________________________________________________ 316

Section 23. Recalls, suspensions, cancellations, and

tampering of medical devices

317

Overview ___________________________________________________________________ 317

Recalls of medical devices _______________________________________________ 317
Stages of a recall________________________________________________________________________ 319

Recall classifications ___________________________________________________________________ 320

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Therapeutic Goods Administration

Recall levels ____________________________________________________________________________ 321

More information about recalls _______________________________________________________ 321

Non-recall actions for medical devices ________________________________ 322

Suspending medical devices from the ARTG __________________________ 323
Cancellation of medical devices from the ARTG ______________________ 324

Date of effect of cancellation of medical devices from the ARTG ___________________ 326

Product tampering ________________________________________________________ 326

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Part 3Post-market

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Section 21. Changes to ARTG

Inclusions
This section to be drafted.

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Section 22. Post-market

vigilance and monitoring
requirements
Overview
Once a medical device has been included in the ARTG the device must continue to meet all the regulatory, safety
and performance requirements and standards that were required for the approval.

The TGA, along with several international partners in the GHTF, have developed agreements and documents to
promote a harmonised approach to medical device regulation around the world. The GHTF has produced a
guidance document Medical Devices Post-market Surveillance: Global Guidance for Adverse Event Reporting for
Medical Devices, which is available from the GHTF website at <http://www.ghtf.org>.

The TGA has mandatory requirements for all manufacturers and sponsors of medical devices. These
requirements are intended to monitor information about medical devices so that appropriate action can be
taken. The requirements facilitate the systematic investigation of failures and/or deviations in the way a device
performs, in an attempt to prevent an adverse event occurring again. For information about the corrective
actions that may be taken, please see Section 23. Recalls, suspensions, cancellations, and tampering of medical
devices.
There are four key stakeholders involved in improving outcomes for users of medical devices:

sponsorswho are responsible for the legal supply of the device in Australia

manufacturers as defined in section 41BG of the Therapeutic Goods Act 1989 (the Act)
the TGAthe Regulator

usersconsumers and health practitioners who by voluntarily reporting concerns with devices enable
issues to be identified and corrective action to be taken

The TGA has a comprehensive strategy for ongoing monitoring and vigilance for medical devices, which includes
four major components:

sponsors ongoing responsibilities

manufacturers ongoing obligations

ongoing monitoring

vigilanceadverse-event management

Sponsors ongoing responsibilities

In accordance section 41FD of the Act, in applying to include a device in the ARTG, the sponsor has certified that:

the products is a medical device

its intended purpose as stated in the application form has been ascertained from the manufacturers
instructions from use, advertising material, technical documentation, and/or project label(s)

the device is correctly classified

the information included with the application is complete and correct

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the device complies with the Essential Principles and the manufacturer has available sufficient information
to substantiate that compliance with the Essential Principles or have procedures in place, including a written
agreement, to ensure that such information can be obtained from the manufacturer within 20 working days
an appropriate conformity assessment procedure has been applied to the device

the sponsor has available sufficient information to substantiate the application of those conformity
assessment procedures or have procedures in place to ensure that such information can be obtained from
the manufacturer within 20 working days
any advertising material relating to the medical device complies with the TGA requirementsfor more
information see Advertising in Section 12. Information about a medical device.

the device does not contain substances that are prohibited imports under the Customs Act

the device is not an excluded device

The sponsor has ongoing responsibilities once a device has been included in the ARTG.

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The Act requires that the sponsor will:

Requirement

Allow entry and

inspections of premises

Example(s)

Deliver samples upon

request

Availability of information

Advertising material

Report details of certain

incidents and
performance issues to the
TGA

Report results of
investigations undertaken
by the manufacturer to
the TGA

Report any overseas

regulatory actions to the
TGA if the product
involved is from the same
batch or production run
that was supplied in
Australia

Assist the TGA and the

manufacturer in
investigations if an
incident occurs

allowing a person authorised by the TGA to enter

and inspect any premises, including outside
Australia, where the devices are manufactured or
located

Legislative reference

section 41FN(1) of the

Act

while on the premises, to inspect the premises and

medical devices on the premises
to take samples of medical devices from the
premises

providing samples of the medical device to the TGA

upon request
access to the technical documentation that
demonstrates compliance with the Essential
Principles

access to the evidence that appropriate conformity

assessment procedures have been applied
on request, provide this information to the TGA
within specified timeframes

section 41FN(2) of the

Act
section 41FN(3) of the
Act

ensuring any advertising material relating to the

medical device complies with the TGA requirements

section 41FN(5) of the

Act

an adverse event has occurred with a product in

another country and the ensuing investigation by
the manufacturer determines that a batch of the
product should be recalled. If the batch is supplied
in Australia the sponsor should notify the TGA of
the overseas action to determine if the same action
should occur in Australia

section 41FN of the Act

Relay the results to the TGA of an investigation into

a returned sample associated with an adverse event
report

section 41FN of the Act

Pass information to the TGA and the manufacturer

during an investigation of an adverse event

section 41FN of the Act

reports events in accordance with the requirements

laid out in the Therapeutic Goods Act 1989 and the
Medical Device Regulations 2002 and this guidance
document

Assist in the gathering of information and samples

from the user

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section 41FN(3)(d) of
the Act

Page 296 of 337

Requirement

Take corrective action

when necessary

Example(s)

recall medical devices

Maintain distribution
records for product
supplied in or exported
from Australia

Conditions imposed when

medical devices are
included in the ARTG

inform the public about medical devices that do not

comply with requirements
Regulation 8.1(b)

records of delivery to:

distribution warehouses
manufacturing sites
retails outlets

For Class III, Class AIMD, and Class IIb implantable

devices to provide annual reports for first three
years that the device is available in Australia

Legislative reference

section 41KA of the Act

section 41FO of the Act

section 41FO(2) of the

Act

Distribution records
Under section 41FO of the Act sponsors of medical devices supplied in and exported from Australia are required
to keep distribution records of the medical devices to:

expedite any recalls of batches of the medical devices

identify the manufacturer of each batch of devices

Sponsors are not required to maintain records of the individual users of medical devices, however the sponsor
should have records of distribution centres, hospitals and export countries the device has been supplied to.
Each sponsor is required to retain the distribution records for their medical devices for:

10 years for Class AIMD, Class III, and Class IIb implantable devices
five years for all other devices

after the last product has been distributed. These records, or copies of the records, must be provided when
requested by the TGA.

The Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use, available on the TGA
website, sets out appropriate procedures for wholesalers and/or distributors to ensure that there is effective,
efficient and safe handling, storage and distribution of products. It is in the sponsor's interest to encourage their
wholesalers to follow this Code.

Annual reports of problemsClass III, Class AIMD and implantable Class IIb medical devices
In addition to the penalties for failing to notify adverse events under sections 41MP, 41MPA,41MPB, 41MQ,
41MR of the Act the vigilance provisions, it is a condition of inclusion in the ARTG (section 41FN) that the
sponsor of a medical device that is:

an AIMD

Class III

implantable Class IIb

provides three consecutive annual reports to the TGA following inclusion of the device in the ARTG (as specified
in 5.8 of the Regulations).
Annual reports are due on 1 October each year. Reports should be for the period 1 July to 30 June.

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The first report following the date of inclusion in the ARTG must be for a period of at least six months but no
longer than 18 months. If the information is limited to the time the device has been on the Australian market
because it hasnt been supplied elsewhere, this should be stated in the report. Subsequent reports are to be
provided on 1 October for a further 2 years.

The annual report must include all complaints received by the manufacturer relating to problems with the use of
the device that have been received by them over the year.
Complaints received by the manufacturer relating to the use of the device, including its supply under a different
name, in other countries where the device is available must also be included.
These reports are reviewed by the TGA and any issues arising will be discussed with the sponsor.

Note: Sponsors of products that have been transitioned to an inclusion, which were previously registered and
were on the ARTG for three years prior to transitioning will have already submitted Annual Reports for these
devices as it was a condition of registration. Annual Reports will not be required for products that meet this
criterion. This should however be noted in Annual Reports to pre-empt enquiries from the TGA.
If the device is included in the
ARTG

then an annual report

after 1 April

will not be required until 1 October the following year

before 1 April

is due in October of that year for information from 1 July of the preceding year
to 30 June

Examplesannual reports of problems with high-risk devices

A Class IIb implantable device is approved for inclusion in the ARTG on 10 March 2007. The first annual report
will be due on 1 October 2007 and should cover the details for the device for the period 1 July 2006 to 30 June
2007. Even though the device has only been available in Australia since 10 March, if the device has been
available in other countries prior to 10 March, the report must include details of any problems reported to the
manufacturer for the period 1 July 2006 to 30 June 2007. The second and third reports are due on 1 October
2008 and 2009 respectively.

A Class III medical device is approved for inclusion in the ARTG on 10 May 2008. The first annual report will be
due on 1 October 2009 and should cover the details for the device for the period 10 May 2008 to 30 June 2009.
The second and third reports are due on 1 October 2010 and 2011 respectively.

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What the sponsor should include in the annual report

ARTG no

Product name
Model no(s)

Number supplied in Australia

Number supplied world wide (Numbers should include devices that are the same but supplied under a
different name in another jurisdiction)

Number of complaints in Australia

Number of complaints world wide

Number of adverse events and incident rates in Australia (Rate= No. of events/ No. Supplied x 100 = Rate%)
Number of adverse events and incident rates world wide

A list of the more common complaints and all of the adverse events

Device Incident Report (DIR) number of those adverse events reported to the TGA

Regulatory/corrective action/notification by manufacturer

An example of how this might be presented is shown below:

ARTG #

Product name

Model #

# supplied in
Aus

# supplied
World Wide

# of complaints

# of Adverse
Events

123456

Knee
prosthesis
femoral
component

ABC 123

200

8000

32

Type of
complaints

Number

Percentage in
Australia

loosening

0.025%

Adverse events

Percentage
world Wide

Aus WW

Aus WW

TGA DIR #

Regulatory
action

DIR 12234

Nil

Reports should be submitted to <[email protected]> where possible. Otherwise, they may be sent to:

Annual Reports
The Coordinator
Medical Device Incident Report Investigation Scheme (IRIS)
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Facsimile: 02 6203 1713
Telephone: 1800 809 361

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Manufacturers ongoing obligations

Manufacturers have ongoing legal obligations for medical devices that they manufacture that are supplied in
Australia. These obligations are outlined in full in the therapeutic goods legislation.

As part of the approval process to market a medical device in Australia a manufacturer must sign an Australian
Declaration of Conformity. The Australian Declaration of Conformity states which conformity assessment
procedures the manufacturer has chosen to use to demonstrate that their medical device meets the Essential
Principles. The ongoing obligations for a manufacturer vary depending on which conformity assessment
procedures they have used. Full details of the ongoing obligations for each of the conformity assessment
procedures are in Schedule 3 of the Therapeutic Goods Regulations (Medical Devices) 2002 (the Regulations).
These surveillance activities are a critical part of the manufacturers overall quality manufacturing system.
Requirement

Manufacturer
must maintain
appropriate
records

Example(s)

implement
appropriate
means to apply
any necessary
corrective action
in relation to the
design or
production of a
device

technical documentation that demonstrates the conformity of

their devices with the Essential Principles

evidence that an appropriate conformity assessment

procedure has been applied

Legislative reference
Schedule 3 of the
Regulations

the Australian Declaration of Conformity

details of any post-market activities undertaken after the

device was supplied in Australia

details of any changes or variations to the device and/or

quality management systemfor more information, please
see Section 21. Changes to ARTG Inclusions.

any notice, report, certificate or other document in relation to

the quality management system issued to the manufacturer
by the TGA

for all devices that are not Class I non-sterile and nonmeasuring:

details of the manufacturers quality management system

the design, production process and intended performance of

the medical device

These records must be kept for a minimum of 5 years after the

manufacture of the last medical device. On request from the
TGA, the manufacturer must make the records available to the
TGA
unless covered by the exemption rules, notify the TGA or the
sponsor, as soon as practicable after becoming aware of:
-

information relating to

any malfunction or deterioration in the

characteristics or performance of the device

any inadequacy in the design, production,

labelling or Instructions for Use of the device

any use in accordance with, or contrary to,

the use intended by the manufacturer of the
kind of device

Schedule 3 of the
Regulations

that might lead, or might have led, to the death of a patient

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Requirement

Example(s)

or a user of the device in Australia, or to a serious

deterioration or serious injury to his or her state of health.
For more information, please refer to Vigilance in this
section
-

Legislative reference

information relating to any technical or medical

reason for a malfunction or deterioration that has
led the manufacturer to take steps to recover
devices that have been distributed
systematically review information gained after the
device was supplied in Australia. Information can
come from many sources, for example:

Expert user groups

Customer surveys

Customer complaints and warranty claims

Service and repair information

Literature reviews

User feedback other than complaints

Device tracking and registration registers

User reactions during training programs

Adverse event reports from users provided

by the TGA

Please note: Even though a certified quality system is not required for manufacturers of Class I medical
devices (non-sterile or non-measuring), the manufacturer is still required to have an ongoing
surveillance system established, in accordance with clause 6.5 of Schedule 3 of the Therapeutic Goods
Regulations (Medical Devices) 2002.

Manufacturers must also notify the TGA of substantial changes to the design, intended performance or quality
management system of the device. For more information on changes, please see Section 21. Changes to ARTG
Inclusions.

Ongoing monitoring of compliance by the TGA

Ongoing monitoring by the TGA is a series of activities carried out to ensure that regulatory compliance and
safety of the medical devices continues after supply to the Australian market.
Monitoring activities may include:

reviews of technical and clinical information to ensure that compliance with the Essential Principles and
conformity assessment procedures is demonstrated

testing to confirm compliance with the Essential Principles

inspections of manufacturers or sponsors records and documentation

on-site testing of medical devices or taking samples for off-site testing
audits of distribution records

audits of the traceability of raw materials used in the manufacture of therapeutic goods and tracking of
component parts

trend analysis and reporting to sponsors

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The TGA may take corrective action in accordance with the legislation if problems are found, such as:

sponsors and/or manufacturers not fulfilling their regulatory responsibilities

safety concerns about a medical device

certifications made in the device application are incorrect or no longer correct

For more information, please see Section 23. Recalls, suspensions, cancellations, and tampering of medical
devices.
Post-market reviews for medical devices

Post-market reviews support the inclusion in the ARTG process for medical devices, which includes both
random, flagged, and targeted reviews.

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There are three levels of post-market reviews for medical devices:

Level

Flagged

(Class I)

Targeted
(All
Classes)

Reason for the Review

restricted word used in

online eBS application

Targeted based on:

Random
(Class I)

outcomes of Flagged
review

recurrent breaches of
advertising code
repeated device test
failures
overseas regulatory
activity/advice

trends from problem

reports
random reviews

unresolved/repeated
recalls

Scope

Objectives of the Review

Intended Purpose of the

device as specified by the
manufacturer

GMDN

Classification

Flagged, Random + any or

all:

manufacturer audit
reports

notice from
manufacturer/sponsor

Manufacturer audit
reports

TGA laboratory testing

Manufacturer audit
clinical evidence
Manufacturers
Evidence

technical file

sterilisation validation
evidence (when
appropriate)

matters certified in the

device application

check accuracy and

consistency of ARTG
information
check appropriate
classification

check accuracy and

consistency of ARTG
information
check appropriate
classification

review available
documentation for potential or
real risks of safety and
performance issues

certifications in device
application remain correct

sponsor is meeting the

conditions of inclusion

manufacturer shows
compliance with the Essential
Principles

implant registries

particular words in the

intended purpose
complaints

Random on ARTG inclusion

Flagged

labels

Instructions for Use

Australian Declaration
of Conformity

check accuracy and

consistency of ARTG
information
check classification
appropriate

manufacturers
advertising material

Please note: it is important to be aware that any advertising material submitted is not assessed for compliance
with the advertising requirements, but is only used to assist with clarifying the manufacturers intended purpose
for the device

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If an application is inconsistent with the definition of a Class I device:

for Flagged reviews, sponsors will be sent a section 41JA letter requesting the Australian Declaration of
Conformity, which will be reviewed and either accepted or

the sponsor will be issued with a proposal to cancel letter with 10 days to respond

Vigilance
The purpose of medical device vigilance is to improve the health and safety of patients, users, and others by
reducing the likelihood of adverse events being repeated. This can be achieved by:

evaluating reported adverse events

disseminating information that could be used to prevent or minimise the consequences of adverse events,
where appropriate

modifying the medical device

removing the medical device from the market

Action is undertaken by the TGA and the sponsor and/or manufacturer after any party becomes aware of
information about a medical device supplied in Australia, such as:

adverse event reports

malfunctions

results of testing

any other information

The manufacturer and sponsor must inform the TGA of all reportable adverse events, within the appropriate
timeframes. They must also ensure timely and appropriate action is taken.

To improve the monitoring of the performance of medical devices supplied in Australia, the TGA encourages the
reporting of adverse events by users of devices.

Vigilance exchange

Through various Mutual Recognition Agreements for medical device regulation and its participation in the Global
Harmonization Task Force (GHTF), the TGA has an obligation to exchange vigilance information with overseas
regulatory agencies. Information will be exchanged on incidents and events where:

corrective action, including a recall, is to be taken

there is a serious risk to the safety of patients or other users, but where the corrective action is still being
determined.

The TGA will consult the sponsor when preparing a vigilance report to be sent to other regulatory agencies. It is
the responsibility of the sponsor to ensure that the manufacturer is aware of the TGA vigilance report, and that
any comments that are made by the manufacturer are passed on to the TGA for consideration. The TGA will only
consider changes that address inaccuracies in the report.

Regulatory agencies generally use discretion where a manufacturer takes corrective action that is not considered
to be essential to protect the safety of patients or others. Examples of this are minor improvements to current
devices and updates of user information. In the case of doubt, however, a regulatory agency will generally
disseminate information.

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Who is notified when there is an issue with a medical device?

Issue identified with a

medical device

Who receives advice about

the incident?

By user

Sponsor

consumer
health
professional

Other sources
manufacturerS
overseas
regulators
sponsors

TGA
Manufacturer

Who else must be told?

Manufacturer
all reports

TGAonly if it
meets the
criteria for a
reportable
adverse event

Sponsorall
reports

The sponsor is legally responsible for the supply of the device in Australia, including the receipt and handling of
complaints and adverse events. The sponsor may receive event reports from users, the TGA, the manufacturer or
other sources, e.g., literature, consumer bodies, professional bodies. The sponsor must forward copies of all
reports to the manufacturer and copies of all reportable adverse event reports to the TGA.
The manufacturer must maintain records of any problems/incidents that occur involving a medical device that
they manufacture that is supplied in Australia. The manufacturer must inform the sponsor of any reports from
users or other information that indicates there is a possible problem with a device supplied in Australia.

The TGA must be notified of any incidents that occur in Australia and that are considered adverse events (please
see below for an explanation of what is considered an adverse event). The TGA will forward details of incident
and the device in the reports from users to the sponsor of the device.

Reportable adverse events

Any event that meets three basic reporting criteria, even if it does not involve a patient or user, should be
reported to the TGA:

an adverse event has occurred

the manufacturers medical device is associated with the adverse event

the event led to or might lead to (often referred to as a near adverse event) death or serious injury, or might
lead to death or serious injury if it were to occur again

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An adverse event is an event that led to:

death

a serious injury or serious deterioration to a patient, user or other person, including

a life-threatening illness or injury

permanent impairment of a body function
permanent damage to a body structure
a condition necessitating medical or surgical intervention to prevent permanent impairment of a body
function or permanent damage to a body structure

A near adverse event is an event that might have led to a death or serious injury. It may be that due to the
timely intervention of a healthcare practitioner a death or serious injury did not occur. For an event to be
defined as a near adverse event, it is sufficient that:

an event associated with the device happened

if the event occurred again, it might lead to death or serious injury

testing or examination of the device or the information supplied with the device, or scientific literature
indicated some factor that could lead to a death or serious injury.

Typical adverse events are as follows:

Event or cause of an adverse
event

Description

Malfunction or deterioration in
the characteristics or
performance of a medical
device

Failure of a device to perform in accordance with its intended purpose when

used in accordance with the manufacturer's instructions

Inadequate design or
manufacture of a device

Design or manufacturing of a device is found deficient

Inaccuracy in the labelling,

Instructions for Use and/or
promotional materials
Significant public health
concern

Other information becoming

available

Please note: intended purpose means the intended use according to the data
supplied by the manufacturer on the labelling, in the Instructions for Use
and/or in advertising materials

Inaccuracies include omissions and deficiencies

omissions do not include the absence of information that should generally be

known by the intended users
Can include an event that is of significant and unexpected nature that
becomes a potential public health hazard, for example, human
immunodeficiency virus (HIV) or CreutzfeldtJacob Disease (CJD)

the TGA, the sponsor, or the manufacturer may identify these concerns
Can include:

information from the literature or other scientific documentation

the results of testing performed by the manufacturer on its products

reports from the user prior to the device being used on the patient

Reporting incidents with medical devices

The act of reporting a problem is not an admission of manufacturer, sponsor, user, or patient liability for the
event or its consequences.
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Only adverse events that occur in Australia are required to be reported to the TGA. Adverse events that occur
overseas for devices supplied in Australia do not need to be reported to the TGA. However, records of these
events should be available if requested. Also, any remedial action that arises overseas for devices supplied in
Australia should be reported. For more information, please see Section 23. Recalls, suspensions, cancellations,
and tampering of medical devices.
The reporting requirements for sponsors are conditions on the inclusion of medical devices in the ARTG.
Breaching conditions of inclusion may lead to suspension or cancellation of the device from the ARTG (section
41G of the Act), as well as constituting a criminal and civil offence (section 41MN of the Act).

The sponsor is responsible for forwarding reports of all incidents to the manufacturer for assessment under the
manufacturer's surveillance system.
Please note: There are exceptions to the requirement to report, which are outlined over the following
pages.

It is possible that the sponsor will not have enough information to decide if the problem should be reported to
the TGA. This judgement may be difficult when there are multiple devices involved. The sponsor should make
reasonable efforts to obtain additional information to assist in making this decision. In assessing the link
between the device and the event, the sponsor should take into account:

the opinion, based on available information, from a health professional

information concerning previous, similar events

other information held by the sponsor

In complex situations, it should be assumed that the device was associated with the event. If there is any doubt
about whether a report should be submitted, the report should be submitted.

Where possible, the manufacturer should consult with the user and/or medical practitioners or other healthcare
professionals involved, and do their utmost to retrieve the particular device.
Please note: Although it is the manufacturer who must assess an incident, the sponsor will be held
accountable for forwarding information concerning events to the manufacturer and then for forwarding
the results of any analysis to the TGA. The manufacturer must advise the sponsor but can also advise the
TGA directly.

Reporting of events or near events by users is voluntary. The TGA promotes and encourages users to report but
cannot enforce reporting by users. Device users are encouraged to report events associated with the use of a
medical device to either the sponsor or the TGA.

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Examples of reportable adverse events

The premature revision of an orthopaedic implant due to loosening or fracture

An infusion pump stops, due to a malfunction, but fails to give an alarm. The patient receives an underinfusion of needed fluids

During the use of an external defibrillator on a patient, the defibrillator failed to deliver the programmed
level of energy due to a malfunction

An intravenous set separates and the comatose patients blood leaks onto the floor, resulting in significant
blood loss

Examples of reportable adverse events involving public health concerns

Fatigue testing performed on a commercialised heart valve bioprosthesis demonstrates premature failure,
which would indicate that a risk to public health could occur

After delivery of an orthopaedic implant, errors were discovered in heat treatment records raising questions
about the effectiveness of the implants materials that would create a risk to public health

A manufacturer provides insufficient details on cleaning methods for reusable surgical instruments used in
brain surgery, despite the obvious risk of transmission of CJD

Please note: A definition of what represents a serious threat to public health can be found in Part 5,
Division 5.2, Regulation 5.7 (2) of the Therapeutic Goods (Medical Devices) Regulations 2002.

Exemptions from reporting adverse events to the TGA

There are eight exemption rules that can apply (see table of exemption rules overleaf). However, these rules do
not apply when:

a device, event or issue specifically identified by the TGA as an issue that requires close monitoring
sponsors of devices that are affected will be notified by the TGA when this occurs

an adverse event normally subject to a reporting exemption, where a change in trend (usually an increase in
frequency) or pattern is identified
adverse events associated with user error, as the TGA may use this data to identify trends with similar
products that may lead to recommendations for:
corrective action for the device

revising the labelling or Instructions for Use

identifying a need for increased user education.

If a manufacturer believes an exemption rule applies to reporting an adverse event, the reasons for not reporting
the event should be documented.

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Exemption Rules from reporting adverse events to the TGA

Rule
No.
1

Exemption Rule

Examples of adverse events exempt from reporting

Deficiency of a new device found by the user prior to its use

Regardless of the existence of provisions in the Instruction for Use provided by the
manufacturer, deficiencies of devices that will be always detected by the user and
where no serious injury has occurred, do not need to be reported.

Please note: If the device is used the exemption does not applythe event must be
reported.

Adverse event caused solely by patient conditions

When the manufacturer has information that the root cause of the adverse event is
due to patient condition, the event does not need to be reported. These conditions
could be pre-existing or occurring during device use.

To justify not reporting, the manufacturer should have information available to

conclude that the device performed as intended and did not cause or contribute to a
death or serious injury. A person qualified to make a medical judgement would
accept the same conclusion.
Service life of the medical device

The service life is defined as the time or usage that a device is intended to remain
functional after it is manufactured, placed into use, and maintained as specified.
The service life must be specified by the device manufacturer and included in the
master record (technical file).
When the only cause for the adverse event was that the device exceeded its service
life and the failure mode is not unusual, the adverse event does not need to be

Australian Regulatory Guidelines for Medical Devices

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A user performs an inflation test (standard procedure) prior to

inserting the balloon catheter in the patient as required in the
instructions for use accompanying the device. Malfunction on
inflation is identified. Another balloon is used. Patient is not
injured.
Sterile single-use device packaging is labelled with the caution
do not use if package is opened or damaged. Open package
seals are discovered prior to use, device is not used.
An intravenous administration set tip protector has fallen off
the set during distribution resulting in a non-sterile fluid
pathway. The intravenous administration set was not used.

An orthopaedic surgeon implants a hip joint and warns against

sports-related use. Patient chooses to go water skiing and
subsequently requires premature revision.
The early revision of an orthopaedic implant due to loosening
caused by the patient developing osteoporosis.

A patient died after dialysis treatment. The patient had endstage-renal disease and died of renal failure.

Loss of sensing after a pacemaker has reached its end of life.

The elective replacement indicator has shown up in due time
according to the device specification. Surgical explanation of
pacemaker is required.

A drill bit was used beyond the end of its specified life. It
fractured during invasive operation. Operation time was
prolonged due to the difficulty to retrieve the broken parts.

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Rule
No.

Exemption Rule

Examples of adverse events exempt from reporting

reported.

Assessment of whether an event is exempt from reporting under this rule must be
based on the information in the master record, on the label or in Instructions for Use
for the device.
Protection against a fault functioned correctly

Adverse events that did not lead to serious injury or death, because a design feature
protected against a fault becoming a hazardous situation (in accordance with
relevant standards or documented design inputs) do not need to be reported.

Remote likelihood of occurrence of death or serious injury

Adverse events that could lead, but have not yet led, to death or serious injury, but
have a remote likelihood of causing death or serious injury, and which have been
established and documented as acceptable after risk assessment do not need to be
reported.

If an adverse event resulting in death or serious injury occurs, the adverse event is
reportable and a reassessment of the risk is necessary. If reassessment determines
that the risk remains remote, previous reports of near incidents of the same type do
not need to be reported retrospectively. Decisions not to report subsequent failures
of the same type must be documented.
6

Please note: A change in the trend (usually an increase in frequency) of these nonserious outcomes must be reported.

Expected and foreseeable side effects that are documented in manufacturers

Instructions for Use or labelling

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An infusion pump stops, due to a malfunction, but gives an

appropriate alarm (for example, in compliance with relevant
standards) and there was no injury to the patient.

Microprocessor-controlled radiant warmers malfunction and

provide an audible appropriate alarm, in compliance with
relevant standards and there was no injury to the patient.

During radiation treatment, the automatic exposure control is

engaged and the treatment stops. Although the patient
receives less than an optimal dose, the patient is not exposed
to excess radiation.

The manufacturer of a pacemaker supplied to the market identified

a software bug and determined that the likelihood of occurrence of
a serious injury with a particular setting is remote. No patients
experienced any adverse health effects.
The manufacturer of blood donor sets obtains repeated complaints
of minor leaks of blood from these sets. No patient injuries from
blood loss or infections of staff have been reported. The chance of
infection or blood loss has been re-evaluated by manufacturer and
deemed remote.

A patient receives a second-degree burn during the use of an

external defibrillator in an emergency. The risk assessment

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Rule
No.

Exemption Rule

Examples of adverse events exempt from reporting

Side effects that are clearly identified in the manufacturers labelling or are
clinically well known as being foreseeable and having a certain functional or
numerical predicability when the device was used as intended need not be
reported.

documents that such a burn has been accepted in view of the

potential patient benefit and a warning is provided in the
Instructions for Use. The frequency of burns is occurring within
range specified in the device master record.

Some of these events are well known in the medical, scientific, or technology fields.
Others may have been clearly identified during clinical investigation and labelled by
the manufacturer.

A patient who has a mechanical heart valve developed endocarditis

ten years after implantation and then died.

Documentation, including the risk assessment, for the particular side effect should
be available in the device master record prior to the occurrence of adverse events.
The manufacturer cannot conclude in the face of events that they are foreseeable
unless there is prior supporting information.
Adverse events described in an advisory notice

Adverse events that occur after the manufacturer has issued an advisory notice
need not be reported individually if they are specified in the notice. Advisory
notices include removals from the market, corrective actions, and product recalls.
The manufacturer should provide a summary report, the content and frequency of
which should be agreed with the TGA.
Reporting exemptions granted by the TGA

A patient has an undesirable tissue reaction that is previously

known and documented in the device master record.

Placement of central line catheter results in an anxiety reaction

and shortness of breath. Both reactions are known and labelled
side effects.

A manufacturer issued an advisory notice and undertook a recall of

a coronary stent that migrated due to inadequate inflation of an
attached balloon mechanism. Subsequent examples of stent
migration were summarised in quarterly reports required for the
recall action and individual adverse events did not have to be
reported.

Upon request by the sponsor, common and well-documented events may be

exempted by the TGA from reporting or changed to periodic reporting on a case by
case basis.

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Timeframes for submitting adverse event reports to the TGA

The reporting requirements are conditions on the inclusion of medical devices in the ARTG. Breaching
conditions of inclusion may lead to suspension or cancellation of the entry from the ARTG as well as constituting
a criminal offence and/or resulting in a civil penalty.
From the Therapeutic Goods Act 1989
5.7

Conditions applying automatically period for giving

information about adverse events etc (Act s 41FN)
For paragraph 41FN (3) (d) of the Act, the period in which a person in
relation to whom a kind of medical device is included in the Register
must give information of a kind mentioned in subsection 41MP (2) of
the Act to the Secretary is:
a. if the information relates to an event or other occurrence that
represents a serious threat to public health 48 hours after
the person becomes aware of the event or occurrence; and
b. if the information relates to an event or other occurrence that
led to the death, or a serious deterioration in the state of
health, of a patient, a user of the device, or another person
10 days after the person becomes aware of the event or
occurrence; and
c. if the information relates to an event or other occurrence a
recurrence of which might lead to the death, or a serious
deterioration in the state of health, of a patient, a user of the
device, or another person 30 days after the person becomes
aware of the event or occurrence.

Details to be included in an adverse event report

There are two report forms available on the TGA website:

Medical device adverse event reporting by medical device usersfor use by medical device users (clinicians,
patients or their relatives, etc) to report any suspected problems with a medical device that has or may
present a health hazard. Typical problems include deficiencies in labelling, Instructions for Use or packaging,
defective components, performance failures, poor construction or design
Medical device adverse event reporting by medical device manufacturers and sponsorsto be used by
medical device sponsors, manufacturers or their authorised representatives for mandatory reporting of
adverse events associated with a medical device

The report should not be unduly delayed if the information is incomplete. It is important to get this process
underway as additional information can always be provided later. It may also include a statement to the effect
that the report is made by the manufacturer and sponsor without prejudice and does not imply any admission of
liability for the incident or its consequences.

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If a person is not able to access the forms on the TGA website, they should ensure that the report includes the
following details:

the sponsor's:

name
address
contact person
telephone number
fax number

manufacturer
sponsor

kind of medical device

commercial name
catalogue number
ARTG number
model number
serial number
batch number
lot number
software version (if applicable)

the date when the incident came to the knowledge of the:

information about the device including the:

if implantable, date of implant and if applicable, date of explant

any associated devices and/or accessories involved in the incident

the known details of the event, including the date and patient or user outcome

the current known location of the medical device involved in the event

the contact point of the user where the event occurred. The patients full identity should not be reported. The
contact point need not necessarily be a person who actually witnessed the event. It is recommended that
health care facilities have a contact person for all reported events

any manufacturer and sponsor comments

the action taken or proposed action and timeframe

a statement of whether the manufacturer and sponsor are aware of the same type of events having an impact
on the current report. The statement should include the:

names of any other regulatory authorities to which these events have been reported
date of the reports
number of similar events
number of devices supplied
rate of similar events, if available
any other countries in which the medical device is known to be on sale or supplied

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Reports should be submitted to <[email protected]> where possible. Otherwise, they may be sent to:

The Coordinator
Medical Device Incident Report Investigation Scheme (IRIS)
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Email: <[email protected]>
Facsimile: 02 6203 1713
Telephone: 1800 809 361

Access to medical devices involved in adverse events

Where possible, a manufacturer, through a sponsor should consult with the medical device user about the event
before a report is submitted to the TGA. The manufacturer may also wish to have access to the medical device
involved in the event to help decide whether the event should be reported to the TGA. Such access would be at
the discretion of the user or healthcare facility concerned, but they are encouraged to assist the manufacturer to
determine the root cause of the incident.
If the manufacturer has access to the medical device, and the initial assessment or cleaning or decontamination
process will involve altering the device in a way that may affect subsequent analysis, the manufacturer should,
through the sponsor, inform the TGA before proceeding.
Where the healthcare facility sends the medical device directly to the TGA, the device will be inspected and its
condition recorded and described. The TGA will not carry out any destructive testing without consulting both
the:

manufacturer, through the sponsor, of the medical device

healthcare facility or reporter.

On completion of the examination the medical device will generally be sent to the manufacturer, again through
the sponsor, for their analysis provided the healthcare facility consents. The TGA encourages release of the
medical device to the manufacturer so that they can complete their analysis.

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What the TGA does when it receives an adverse event report

TGA undertakes Initial

Risk Assessment and
logs report in database

Reports discussed by
Incident Report
Evaluation Committee

Investigation
undertaken

Yes

Investigate?

No

Log in database and

monitor trend

Report Outcome to
the reporter and the
sponsor
Report outcome and
recommendations to
the reporter and the
sponsor

Report closed

Referred to other areas

of the TGA if necessary

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The following is a summary of the key components of the TGAs strategy for investigating incident reports:

Urgent, serious reports are reviewed and addressed as soon as possible by the TGA.

A panel of scientific, engineering, and clinical experts assesses all reports. The panel determines what level
of investigation will take place
Isolated incidents or problems with a very low clinical risk and no impact on device performance are not
usually investigated

When a report is investigated the person who is investigating will contact the company responsible for the
device and work with them to resolve issues

Reporters details are treated as confidential. Both the reporter and the supplier are informed of the
outcome of the investigation

All reports are entered into a database so that a trend analysis can be conducted and are easily referenced in
the future

The outcome of an investigation may include one or more:

referral to other areas of TGA for regulatory actions, such as auditing of the manufacturer
recall of the devices to:

remove the devices from supply in Australia

allow correction at the users site

the issue of a Safety Alert where there is a need to reinforce the manufacturers Instructions for Use to those
responsible for the use of the device or those affected by the problem

product improvement for problems that are not safety related - carried out by the manufacturer

report in the TGA News, on the TGA website and/or appropriate journals

For more information on these actions, please see Section 23. Recalls, suspensions, cancellations, and tampering
of medical devices

TGA testing of devices

Medical devices involved in an adverse event may be sent to the TGA for testing. The TGA accepts devices that
are contaminated. The TGA can test or visually inspect all medical devices, although there are some devices for
which the TGA cannot do a complete examination as the equipment available for some of the tests is specific to
the device manufacturer. The TGA will, however, test or examine the device as much as it is able, and, if granted
permission by the reporter, the device will be sent to the manufacturer for further testing. Analysis of the
manufacturer's testing is required by the TGA as part of its investigation of the adverse-event report.
It is important that users keep the device after submitting a report, until the TGA has contacted them to advise
whether the device should be sent to the TGA or the sponsor/manufacturer.

Please refer to the TGA website <http://www.tga.gov.au> for instructions on how to send a medical device to the
TGASamples for testing - Protocol for sending medical devices to the TGA for testing.

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Section 23. Recalls,

suspensions, cancellations,
and tampering of medical
devices
Overview
Once a medical device has been approved for supply in Australia the device must continue to meet all the
regulatory, safety and performance requirements and any applicable standards.

If there is a problem with a medical device or the way in which it is being used, the sponsor and manufacturer
will first conduct an analysis and make a decision on the appropriate action. One of these actions may require
notifying or obtaining further advice from the TGA. Some actions that may need to be taken could include to:

follow corrective actions / preventive actions procedures under the sponsor/manufacturers quality
management system or for Class 1 devices follow the post-market requirements under Part 6.5, Schedule 3
of the Therapeutic Goods (Medical Devices) Regulations 2002

inform the users of the device

make corrections to the device

remove the device from the market

As a regulator, the TGA has established procedures for the ongoing monitoring and vigilance for medical devices
supplied in Australia. This includes a range of penalties for the inappropriate supply of medical devices.

Recalls of medical devices

If the sponsor or manufacturer is contemplating any of the following:

correcting product on the market

removing product from the market, or

advising users of an issue with a medical device

contact the Australian Recall Coordinator at the TGA via 02 6232 8636 or email <[email protected]> for advice.

When the need for a recall of a medical device supplied in or exported from Australia has been established, the
sponsor of the affected device is responsible for the recovery of the devices. There are two key types of recalls:

correction, which may involve temporary removal from the market or from use
permanent removal of deficient medical devices from the market or from use

Most recalls are conducted on a voluntary basis. Where recall is refused, or is not carried out satisfactorily, the
TGA may order a mandatory recall. Failure to comply with such an order may result in substantial fines.

The Therapeutic Goods Act 1989 (the Act), in conjunction with the Trade Practices Act 1974, provides the
legislative basis for recalls of therapeutic goods. Recall provisions can be applied under section 41KA of the Act
when:

the medical device does not meet the Essential Principles

conformity assessment procedures have not been applied to the medical device

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the medical device has been illegally supplied

the medical device has been cancelled or suspended from the ARTG.

In addition, in accordance with section 42V of the Act a recall may be conducted where therapeutic goods have
been or could possibly be, subject to actual or potential tampering.

The Uniform Recall Procedure for Therapeutic Goods (URPTG), available on the TGA website, provides detailed
information about the action to be taken by health authorities and sponsors when medical devices available in
Australia are to be removed from supply or use, or are subject to corrective action
The sponsor has the prime responsibility for implementing recall action, and for ensuring compliance with the
recall procedure at its various stages. However, no recall, regardless of level, should be undertaken without
consultation with the Australian Recall Coordinator and without agreement on the recall strategy.
The role of the TGA is to assist the sponsor by:

advising the sponsor immediately of problem reports with medical devices that may necessitate recall

where there may be a hazard to the user, providing expert advice on the classification and level of recalls.
More information on classifications and levels of recalls in Australia is provided later in this Section

providing advice and assistance in relation to letters, advertisements and recall strategies

notifying agreed third parties, such as state/territory health departments, overseas regulatory agencies, the
Australian Competition and Consumer Commission

monitoring the overall action

considering and reaching agreement with the sponsors recall process or in serious situations to mandate a
recall. Appeal provisions will apply with a mandated recall and would be provided

Please note: A Hazard Alert may be issued by the sponsor for implantable medical devices where it has
been proven that there is no stock to be recalled and all affected devices are already implanted. The
appropriate action to be taken for a device that has been implanted in a patient should be discussed with
the Australian Recall Coordinator, as the risks of surgery to replace the implantable device must be
balanced against the risk of a problem occurring with the device

Please note: A Hazard Alert as defined in URPTG is issued by the sponsor for implanted medical devices
as part of a recall action
A Safety Alert as defined in URPTG is not related to a recall and is intended only to provide information
on the safe use of a medical device where the issue was related to the inappropriate use of the device. A
Safety Alert is issued by the sponsor or manufacturer not the TGA

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Stages of a recall
Notification to the Australian Recall Coordinator at the TGA
Information on device, risk analysis, problem and distribution to be provided to the
TGA by sponsor
Liaison between sponsor and Australian Recall Coordinator to determine classification,
level and strategy for recall
Letters and (and as necessary) advertisements submitted by sponsor to Australian
Recall Coordinator for approval before despatch
If recall is safety-related the Sponsor is required to notify the Minister responsible for
Consumer Affairs.
Sponsor forwards progress reports to the Australian Recall Coordinator
Effectiveness of recall monitored by the Australian Recall Coordinator

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Recall classifications
Recalls are classified as follows:
Classification
Class I

(Safety related)

Description

Product defects are

potentially lifethreatening or could
cause permanent
debilitating health
issues

Examples

Class II

(Safety related)

Product defects could

cause illness or
mistreatment and the
recovery of the patient
is likely

Class III

(Non-Safety
related)

Product defects may

not pose a significant
hazard to

health, but withdrawal

may be initiated for
other reasons

Hot/cold gel packs that contain a toxic substance that could

be ingested accidentally by a young child

A software error in a CT scanner that could cause the gantry

to rotate in an unintended direction and cause an injury to
or the death of a patient

Implantable pacemakers with a defect that results in a loss

of pacing output, which for pacemaker-dependent patients
may result in death or serious injury
A false result on an IVD test for a medicine with a narrow
therapeutic index that could lead to an overdose, causing
permanent injury
Microbial contamination of a surgical lubricant

A software error in a radiation treatment planning tool that

could lead to therapy being miscalculated and incorrectly
administered

The Instructions for Use for a catheter omits a precaution for

certain procedures that could cause complications in its
removal
The incorrect combination of metal femoral heads and
liners has been supplied to surgeons. If implanted then
there is a high risk of accelerated wear and tear
An IVD test kit that could identify the wrong strain of
micro-organism and lead to inappropriate treatment

A disinfectant has been mislabelled with an expiry date that

predates the actual expiry date

The outer packaging of a consumable medical device

indicates a different size to that which is actually in the
supplied in the box. It would be obvious to the clinician that
the consumable was the incorrect size
An IVD reagent is causing calibration failures towards the
end of its shelf life. There is no effect on patient results

Class I or Class II recalls are considered to be urgent safety-related recalls. Class III recalls are considered to be
routine non safety-related recalls

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Recall levels
The sponsor determines the applicable outlets in accordance with the URPTG.
There are four levels of recall in Australia:
Level

Wholesale
Hospital

Outlets

nursing homes, hostels and other institutions

clinical investigators and the institutions in which clinical investigations are performed
hospital pharmacists, blood banks, pathology laboratories, operating facilities

fractionators, human tissue banks and personnel in other hospital departments

Ambulance Services, Flying Doctor Services

Outlets at the wholesale and hospital levels and where applicable any of the following:

Consumer

State purchasing authorities

Outlets at the wholesale level and where applicable any of the following:

Retail

medicine and medical device wholesalers

retail pharmacists

medical, dental and other health care practitioners

other retail outlets, e.g., supermarkets and health food stores

Outlets at the wholesale, hospital, and retail levels and where applicable patients and other
consumers

More information about recalls

For further information on recalls of medical devices, please refer to the Uniform Recall Procedure for
Therapeutic Goods available on the TGA website or contact the:

Australian Recall Coordinator

Office of Product Review
Therapeutic Goods Administration
MDP 122
PO Box 100
WODEN ACT 2606
Telephone: 02 6232 8636

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Non-recall actions for medical devices

Where the sponsor is unsure of the appropriate action to be taken, and particularly in cases where patient safety
may be a consideration, the issues involved should be discussed with the Australian Recall Coordinator.
Other action may be taken by a sponsor voluntarily that is not considered to be a recall:
Action

Safety Alert

Description

Product Notification

Product Withdrawal

Product Recovery

User information

intended to provide information on safe use of devices, as distinct from recall

action, which addresses product deficiencies

are issued to provide additional advice to health professionals in situations

where the device, although meeting all specifications and therapeutic indications,
its use could present an unreasonable risk of substantial harm if certain specified
precautions or advice are not observed. For example, specific precautions about
the longevity of an implanted medical device
issue of precautionary information about a device in a situation that is unlikely to
involve significant adverse health consequences
sponsor's removal from supply or use of devices for reasons not related to their
quality, safety or performance
the sponsor recovers devices that have been manufactured or imported but not
yet supplied to the market. For example, recovery of devices in a warehouse
generally conducted by the sponsor in response to issues with the use of a
medical device

includes in-house sessions, seminars and improved educational materials such as

posters

Please note: Terms such as upgrade notice, market correction, field safety correction that are commonly
used by overseas manufacturers and/or regulators may be considered a recall in Australia.
If a sponsor is uncertain of the interpretation of these terms please contact the Australian Recalls Cocoordinator for advice.

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Suspending medical devices from the ARTG

The Therapeutic Goods Act 1989 provides the TGA with the power to suspend a medical device from the ARTG, as
follows:
Legislative reference

Section 41GASuspension
of kinds of medical devices
from the register

Description

Section 41GBNotice of
proposed suspension must
be given in certain cases

Section 41GCDuration of
suspension

Section 41GDRevocation
of suspension
Section 41GETreating
applications for revocation
as having been refused

the TGA Delegate may by written notice suspend a device from the ARTG if:

the TGA will:

Section 41GFSuspensions
of kinds of medical devices
from the Register

there is a potential risk of death, serious illness or serious injury if the

device continues to be included in the ARTG and
it is likely that the sponsor and/or the manufacturer will within the
period of the suspension, be able to take the action necessary to
ensure that the kind of device would not cause a potential risk of
death, serious illness or serious injury if it were to continue to be
included in the ARTG; or
that it is likely that there are grounds for cancelling the entry under
division 2
the suspension may be limited to one or more medical devices of that kind
covered by the ARTG inclusion

inform the sponsor by written notice of the proposed suspension and set
out the reasons for it
give the sponsor an opportunity to make submissions to the TGA in
relation to the proposed suspension
consider any submissions the sponsor makes before making a decision
relating to the proposed suspension

the period of the initial suspension will not exceed 6 months, but may be
extended by up to another 6 months

the suspension may be revoked if the grounds for the suspension no longer
apply, for example, if the corrective action is implemented within the
timeframe. The suspension can be revoked on the written request of the
sponsor or on the TGAs own initiative.
if the suspension is not revoked by the TGA Delegate before the end of the
suspension period (for example, the corrective action has not been
implemented in the timeframe), the device is automatically cancelled from
the ARTG

does not affect the powers to cancel an entry

the TGA may by written notice suspend a device from the ARTG if a
conformity assessment certificate (either issued in Australia or by an
overseas regulatory agency) is suspended
the suspension in place until revoked by TGA Delegate

The TGA must publish in the Gazette, as soon as practicable, a notice setting out the suspension, any extensions
to the suspension, and the revocation of the suspension.

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Cancellation of medical devices from the ARTG

The TGA will cancel devices from the ARTG under Part 4-6 of the Act in cases where there has been a breach of
the legislation or safety or performance issues associated with the use of the device that has or could lead to risk
of death, serious illness or injury. If the devices are cancelled from the ARTG, the sponsor may be required to
recall any affected devices. There are four legislative provisions for cancelling medical devices from the ARTG:
Legislative
reference

Section 41GK
Automatic
cancellation of
medical devices
from the ARTG

Section 41GL
Immediate
cancellation of
devices from the
ARTG

Description

The TGA must cancel a device from the ARTG if:

the device has been suspended from the ARTG under section 41GA of the Act, and the
period applying to the suspension expires before the suspension is revoked under
section 41GD; or
a TGA Conformity Assessment Certificate applying to that device is revoked under
Part 4-4 of the Act.

The TGA will provide written notice of the cancellation to the sponsor of the device.

The TGA may, by written notice given to the sponsor, cancel the entry of a device from the
ARTG if:

the TGA Delegate is satisfied that there would be an imminent risk of death, serious
illness or serious injury if the device continues to be included in the ARTG; or

devices of that kind are no longer therapeutic goods; or

devices of that kind are no longer medical devices; or

the sponsor requests in writing the cancellation of the entry of the kind of device from
the ARTG; or
the TGA Delegate is satisfied that a statement made in or in connection with the:

Section 41GM
Cancellation of
devices from the
ARTG after
section 41JA
notice

application for including the device in the ARTG

the certification or purported certification under section 41FD of the Act relating to
the application;

was false or misleading; or

the annual charge is not paid within 20 working days after it becomes payable; or
the sponsor does not comply with the direction or requirement to ensure that
advertising complies with the Therapeutic Goods Advertising Code; or

there is a serious breach involving the device, of the requirements relating to

advertising applicable under Part 5-1 or under the Regulations, and the TGA Delegate is
satisfied that the breach is significant and the presentation of the devices is misleading
to a significant extent.

The TGA may, by written notice given to the sponsor cancel the entry of a device from the
ARTG if:

the TGA gives the sponsor a notice under section 41JA requiring them to give the TGA
information or documents relating to the device and

the notice is given for the purposes of ascertaining whether the device should have
been included in the ARTG
the sponsor fails to comply with the notice within a further 10 working days from
the day specified in that notice

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Legislative
reference

Description

the TGA gives the sponsor a notice under section 41JA requiring them to give the TGA
information or documents relating to whether medical devices are being:

Section 41GN
Cancellation of
entries of devices
from the ARTG
after notice of
proposed
cancellation

supplied in Australia
imported into Australia
exported from Australia

and either the:

information or documents given are to the effect that medical devices of that kind
are not being supplied in Australia, imported into Australia or exported from
Australia; or
sponsor fails to comply with the notice within a further 10 working days from the
day specified in that notice.

Before cancelling the device from the ARTG under this section of the Act, the TGA must:

inform the sponsor in writing of the proposed cancellation and set out the reasons for
it; and

give the sponsor a reasonable opportunity to make submissions to the TGA in relation
to the proposed cancellation.

The TGA will not make a decision relating to the proposed cancellation until any
submissions from the sponsor have been considered.

Examples of when the TGA may, by written notice to the sponsor, cancel a device from the
ARTG are if:

a medical device has changed since inclusion on the ARTG so that device is no longer a
device of the same kind

the sponsor refuses or fails to comply with a condition to which that inclusion is subject

the sponsor does not comply with a request for information under section 41JA of the
Act

the sponsor does not notify the TGA of adverse events within the required timeframes
the TGA is satisfied that the safety or performance of the device is unacceptable

the TGA is satisfied that certification in relation to the application for inclusion of the
device in the ARTG is incorrect, or is no longer correct. This includes:

compliance with the Essential Principles

application of conformity assessment procedures
compliance with advertising requirements.

The TGA must arrange for a notice to be published in the Gazette setting out particulars of the cancellation, as
soon as practicable, after cancelling an entry from the ARTG.

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Date of effect of cancellation of medical devices from the ARTG

If the TGA cancels a medical device from the ARTG the cancellation has effect:

if the cancellation is under section 41GK or 41GLon the day on which the notice of cancellation is given to
the sponsor

in any other case, on the date specified in the notice but not earlier than 20 working days after the notice is
given to the sponsor

Product tampering

Any and all reports of actual or potential tampering with a medical device will be taken seriously and
investigated, and should be immediately reported to the Australian Recall Coordinator. There is also a legal
obligation for the sponsor under Section 42T of the Act to report such matters to the TGA within 24 hours of
becoming aware.
The Australian Recall Coordinator will convene a Crisis Reference Group (CRG) that will co-ordinate the
activities required to resolve the crisis. For any tampering crisis, the CRG will comprise the:

Australian Recall Coordinator

State or Territory Health Department Recall Co-ordinator

appropriate State Police officers nominated for this purpose by the Police Ministerial Council

senior personnel of the company concerned

The following documents have been developed as joint industry-government initiatives with the aim of assisting
managers in responding to a product contamination and/or extortion event directed at the therapeutic goods
industry:

Product Contamination & Extortion - A Protocol for the Therapeutic Goods Industry

Crisis Management Guidelines - For the management of actual, potential or threatened tampering of medicines,
complementary healthcare products and medical devices

In order to maintain the usefulness of these documents, their availability is being limited to legitimate
therapeutic goods industry stakeholders. These documents are available to sponsors from therapeutic goods
industry associations or the TGA. Where a sponsor is a member of an industry association, access should be
sought through that association in the first instance.

Where a sponsor of therapeutic goods is not a member of an industry association, a written request for a copy of
the documents can be forwarded to the TGA. Such a request should be signed by a duly authorised person
occupying a senior position within the sponsor's company.
Written requests should be forwarded to the:

Australian Recall Coordinator

Office of Product Review
Therapeutic Goods Administration
MDP 122
PO Box 100
WODEN ACT 2606
Telephone: 02 6232 8636

Any requests for a copy of the documents by persons who are not sponsors of therapeutic goods will be
considered on a case-by-case basis and may be referred to an expert committee for advice on whether release
would be in the best interests of the therapeutic goods industry.

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Therapeutic Goods Administration

PO Box 100 Woden ACT 2606 Australia
Email: [email protected] Phone: 02 6232 8444 Fax: 02 6232 8605
www.tga.gov.au
R11/72677