(A) Checklist for the grant of Import license in Form MD-15 for Medical Devices

under Medical Devices Rules, 2017

Form Type: Fresh application in Form MD-14

Section no. Checklist Name
1 Covering Letter
2 Application (Form MD-14)
3 Fee Challan

Power of Attorney along with undertaking from the authorized agent as per Part I
of Fourth Schedule of MDR, 2017 (duly authenticated in India either by a
4
Magistrate of First Class or by Indian Embassy in the country of origin or by an
equivalent authority through apostille)
Copy of Whole Sale licence / Manufacturing licence / Registration
5
Certificate in Form MD-42 of the Authorized agent
6 Constitution details of the authorized agent
7 Regulatory Certificate
Copy of Free Sale Certificate/Marketing Authorization of the product issued by
7.1 the National Regulatory Authority of country of origin (if any) (duly notarized)

Copy of Free Sale Certificate Marketing Authorization of the product isued from
7.2 National Regulatory Authority of any of the following countries viz USA, UK, EU,
Canada, Japan or Australia (duly notarized)

Copy of overseas manufacturing site / establishment / plant registration, by

7.3 whatever name called, in the country of origin issued by the competent authority
(duly notarized)
Copy of latest inspection or audit report carried out by the Competent
7.4
Authority within last 3 years, if any.
Quality Certificate in respect of the actual manufacturing site, as
8
applicable
Copy of Certificate supporting Quality Management System (duly
8.1
notarized)

Copy of Full Quality Assurance Certificate/ CE type examination Certificate/

CE product quality assurance certificate, CE design Certificate, etc as
applicable (duly notarized)
8.2
8.3 Declaration of conformity issued by the manufacturer
Plant Master file from the Manufacturer as per Appendix I of Fourth Schedule of
9
Medical Devices Rules, 2017

Device Master file from the Manufacturer as per Appendix II of Fourth

10
Schedule of Medical Devices Rules, 2017
10.1 Executive Summary
10.2 Descriptive information of the device

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 10.3 Justification for the Medical Device Grouping
10.4 Product Specification, including variants, accessories, etc
Substantial equivalence with reference to the predicate device or previous
10.5
generations of the device
10.6 Labelling information (Labels, Instruction for Use, etc)
10.7 Device Design and Manufacturing Information
Essential Principles checklist for demonstrating conformity to the Safety and
10.8
Performance of the Medical Device
10.9 Risk analysis and control summary
10.1 Verification and validation of the medical device
10.11 Biocompatibility validation data (if applicable)
10.12 Medicinal substances data (if device contains Drug)
10.13 Biological Safety (TSE/BSE), if applicable
10.14 Sterilization Validation data (if applicable)
10.15 Software verification and validation (if software used)
10.16 Animal studies – Preclinical data (if any)
Stability study data (Real-time and Accelerated conditions) for the claimed shelf life
10.17
(if applicable)
10.18 Clinical evidence (if any)
10.19 Post Marketing Surveillance data (Vigilance reporting)
Batch Release Certificates or Certificate of Analysis for minimum 3consecutive
10.20
batches/ Software version release certificate
11 Any other additional documents
Copy of Permission in Form MD-27 (incase of Investigational Medical
12
Device )

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(B) Checklist for the grant of Import license in Form MD-15 for additional Medical
Devices under Medical Devices Rules, 2017

Form Type: Endorsement application in Form MD-14

Section no. Checklist Name
1 Covering Letter
2 Application (Form MD-14)
3 Fee Challan

Power of Attorney along with undertaking from the authorized agent as per Part I of
Fourth Schedule of MDR, 2017 (duly authenticated in India either by a Magistrate of
4 First Class or by Indian Embassy in thecountry of origin or by an equivalent authority
through apostille)
Copy of Import License obtained for which the endorsement is applied
5

6 Regulatory Certificate

Copy of Free Sale Certificate/Marketing Authorization of the productissued by the

6.1 National Regulatory Authority of country of origin (if any) (duly notarized)

Copy of Free Sale Certificate Marketing Authorization of the productisued from

National Regulatory Authority of any of the following countries viz USA, UK, EU,
6.2 Canada, Japan or Australia (duly notarized)

Quality Certificate in respect of the actual manufacturing site, as

7
applicable (duly notarized)
7.1 Copy of Certificate supporting Quality Management System
Copy of Full Quality Assurance Certificate/ CE type examinationCertificate/ CE
7.2 product quality asurance certificate, CE design Certificate, etc as applicable

7.3 Declaration of conformity issued by the manufacturer

Undertaking from the overseas manufacturer stating that there is no major
change(s) in the existing Plant Master File (PMF). Otherwise, information as per
8 Appendix I of Fourth Schedule of Medical Devices Rules, 2017 needs to be
submitted.

Device Master file from the Manufacturer as per Appendix II ofFourth

9 Schedule of Medical Devices Rules, 2017
9.1 Executive Summary
9.2 Descriptive information of the device
9.3 Justification for the Medical Device Grouping
9.4 Product Specification, including variants, accessories, etc
Substantial equivalence with reference to the predicate device or previous
9.5
generations of the device
9.6 Labelling information (Labels, Instruction for Use, etc)
9.7 Device Design and Manufacturing Information

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 Essential Principles checklist for demonstrating conformity to the Safety and
9.8
Performance of the Medical Device
9.9 Risk analysis and control summary
9.1 Verification and validation of the medical device
9.11 Biocompatibility validation data (if applicable)
9.12 Medicinal substances data (if device contains Drug)
9.13 Biological Safety (TSE/BSE), if applicable
9.14 Sterilization Validation data (if applicable)
9.15 Software verification and validation (if software used)
9.16 Animal studies – Preclinical data (if any)
Stability study data (Real-time and Accelerated conditions) for the claimed shelf life
9.17 (if applicable)
9.18 Clinical evidence (if any)
9.19 Post Marketing Surveillance data (Vigilance reporting)
Batch Release Certificates or Certificate of Analysis for minimum 3consecutive
9.20
batches/ Software version release certificate
10 Any other additional documents
Copy of Permission in Form MD-27 (incase of Investigational Medical Device )
11

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 (C) Checklist for the retention of import license granted in Form MD-15 for
Medical Devices under Medical Devices Rules, 2017

Form Type: Retention application for Form MD-15

Section no. Checklist Name

1.0 Covering letter

2.0 Duly Signed Retention Form
3.0 Fee Challan

4.0 Copy of the existing Import licence or its retention (if obtained)
5.0 Copy of endorsement(s) to the existing Import license
List of the device(s) deleted from the existing lmport license along with the reason
6.0
Detailed breakup of the fees deposited in terms of site, risk class of the device and
7.0
Medical device grouping etc.
An undertaking from the manufacturer stating that there is no major change(s) in
8.0 the existing Device Master File (DMF) and Plant Master File (PMF)

Post marketing surveillance data (Vigilance reporting) during last 5 yrs (details of
9.0 complaints, recall (if any), CAPA taken, etc), duly authenticated by the manufacturer or
authorized agent.
Copy of Free Sale Certificate/Marketing Authorization of the product issued by the
10.0 National Regulatory Authority of country of origin (if any), (duly notarized)
Copy of Free Sale Certificate Marketing Authorization of the product isued from
National Regulatory Authority of any of the following countries viz USA, UK, EU,
11.0
Canada, Japan or Australia (duly notarized)
12.0 Copy of Certificate supporting Quality Management System
Copy of Full Quality Assurance Certificate/ CE type examinationCertificate/ CE
13.0 product quality assurance certificate, CE design Certificate, etc as applicable
14.0 Declaration of conformity issued by the manufacturer
An undertaking by the manufacturer and authorized agent, stating that they have
15.0 agreed for retention of the Import License Number, for applied products
Undertaking by the manufacturer and authorized Indian agent stating that there is no
change in the Power of Attorney (POA).
In case any change, a fresh POA along with undertaking from theauthorized agent as
per Part I of Fourth Schedule of MDR, 2017 (duly authenticated in India either by a
16.0
Magistrate of First Class or by Indian Embassy in the country of origin or by an
equivalent authority through apostille) shall be submitted.
Undertaking from the foreign manufacturer as well as from the authorized agent
17.0 stating that there is no change in the Constitution of the firm

Undertaking stating that they shall submit the requisite fees for allthe products
18.0 endorsed in the base license before completion of the five years from the date of issue
of the base license.
Post Approval Changes taken due to change in name and/or address of the firm,
19.0
product details (if any)

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