CHECKLIST
Form Name: Form MD-8
Category: MD
FRESH
Section no. Checklist Name Is Mandatory
1.0 Covering letter Yes
Details of the constitution of the firm along
2.0 Yes
with the relevant documents
The Establishment /Site ownership /Tenacy
3.0 Yes
Agreement
Agreement between the applicant and the
4.0 manufacturer whose manufacturing site is to Yes
be utilized for the manufacturing of applied
device(s)
Copy of manufacturing license of the
5.0 manufacturer showing that the their facility is Yes
licensed for manufacturing of the same
device (s)
6.0 Plant Master File requirements: No
Undertaking from the manufacturer (parent
6.1 firm) stating that there is no major changes Yes
in the Plant Master File
7.0 Quality Management System Requirements: No
Undertaking signed by the manufacturer
7.1 stating that the manufacturing site is Yes
incompliance with the provisions of the Fifth
Schedule of MDR, 2017 for manufacturing of
applied devices
Information on the Device Master File from
8.0 No
the Manufacturer:
Undertaking from the manufacturer (parent
8.1 firm ) stating that the Device Master File of Yes
the approved product applies for the
proposed product
8.2 Executive Summary of the applied devices Yes
8.3 Descriptive information of the applied device Yes
8.4 Justification for the Medical Device Grouping Yes
Product Specification, including variants and
8.5 Yes
accessories of the applied devices
Labelling Details (Labels and Instruction for
8.6 Yes
Use)
Essential Principles checklist for
8.7 demonstrating conformity to the Safety and Yes
Performance of the Medical Device
8.8 Risk analysis and control summary Yes
Biocompatibility validation data (if
8.9 Yes
applicable)
8.10 Sterilization Validation data (if applicable) Yes
Stability study data (Real-time and
8.11 Yes
Accelerated conditions)
Post Marketing Surveillance data (Vigilance
8.12 Yes
reporting)
Batch Release Certificates or Certificate of
8.13 Analysis for minimum 3 consecutive batches/ Yes
Software version release certificate of the
approved product
9.0 Any other additional documents Yes
10.0 Application (Form MD-8) Yes
11.0 Fee Challan Yes
ENDORSEMENT
Section no. Checklist Name Is Mandatory
1.0 Covering Letter Yes
Agreement between the applicant and the
2.0 manufacturer whose manufacturing site is Yes
to be utilized for the manufacturing of
applied device(s)
Copy of manufacturing license of the
3.0 manufacturer showing that the their facility Yes
is licensed for manufacturing of the same
device (s)
4.0 Plant Master File requirements: No
Copy of manufacturing license of the
4.1 manufacturer showing that the their facility Yes
is licensed for manufacturing of the same
device (s)
5.0 Quality Management System Requirements: No
Undertaking signed by the manufacturer
5.1 stating that the manufacturing site is in Yes
compliance with the provisions of the Fifth
Schedule of MDR, 2017 for manufacturing of
applied devicesUndertaking signed by the
manufacturer stating that the manufacturing
site is in
compliance with the provisions of the Fifth
Schedule of MDR, 2017 for manufacturing of
applied devices
Information on the Device Master File from
5.2 No
the Manufacturer:
Undertaking from the manufacturer (parent
5.3 firm ) stating that the Device Master File of Yes
the approved product applies for the
proposed product
5.4 Executive Summary of the applied devices Yes
5.5 Descriptive information of the applied device Yes
5.6 Justification for the Medical Device Grouping Yes
Product Specification, including variants and
5.7 Yes
accessories of the applied devices
Labelling Details (Labels and Instruction for
5.8 Yes
Use)
Essential Principles checklist for
5.9 demonstrating conformity to the Safety and Yes
Performance of the Medical Device
5.10 Risk analysis and control summary Yes
Biocompatibility validation data (if
5.11 Yes
applicable)
5.12 Sterilization Validation data (if applicable) Yes
Stability study data (Real-time and
5.13 Yes
Accelerated conditions)
Post Marketing Surveillance data (Vigilance
5.14 Yes
reporting)
Batch Release Certificates or Certificate of
5.15 Analysis for minimum 3 consecutive Yes
batches/ Software version release certificate
of the approved product
6.0 Any other additional documents Yes
7.0 Fee Chalan Yes
8.0 Legal Form Yes
RETENTION
Section no. Checklist Name Is Mandatory
1.0 Covering letter Yes
1.0 Covering Letter Yes
1.1 Constitution of the Firm Yes
The Establishment /Site ownership /Tenacy
1.2 Yes
Agreement
Copy of Duly notarized valid copies of Quality
2.0 Certificate in respect manufcturing site(s), if No
any
Copy of the existing manufacturing licence or
2.0 Yes
its retention (if obtained) of the loan licensee
Copy of Certificate supporting quality
2.1 Yes
management system (ISO: 13485), if any
Copy of endorsement(s) to the existing
3.0 Yes
manufacturing license
Plant Master file from the Manufacturer as
3.0 specified in Appedix 1 of Forth Schedule of No
Medical Devices Ruless
Part – 1 Plant Layout of premise with
3.1 Yes
indication of scale
Part – 2 Organisation chart showing the
3.2 Yes
arrangements for key personnel
Part – 3 Qualification, Experience and
3.3 Yes
responsibilities of key Technical Persons
3.4 Part – 4 List of Equipment and Instruments Yes
3.5 Part – 5 Contract Activities if any Yes
Copy of the existing manufacturing licence or
4.0 Yes
its retention (if obtained) of the parent firm
4.0 Quality Management System No
4.2 Part – 2 Quality Manual Yes
4.3 Part – 3 Quality Policy Yes
4.4 Part – 4 Control of Documents Yes
4.5 Part – 5 Control of Records Yes
4.6 Part – 6 Management Responsibility Yes
4.7 Part – 7 Internal Audit System Yes
4.8 Part – 8 Preventive and Corrective Action Yes
Part – 9 Procedure for identifying training
4.9 needs and ensure that all persons are trained Yes
to adequately perform their assigned
responsibilities.
Part – 10 Table the areas showing the
4.10 environmental requirement for Medical Yes
Devices as per Annexure A of Fifth Schedule
of Medical devices Rules, 2017.
Device Master file from the Manufacturer as
5.0 specified in Appendix II (only for Medical No
Devices) of Forth Schedule of Medical Device
Rules. Note: In case of Class A devices,
Appendix II is not required. For Class A
devices upload information as specified in
Part II of Forth Schedule for Medical Devices
or IVDs, as the case may be.
List of the device(s) deleted from the existing
5.0 Yes
manufacturing license along with the reason
5.1 Part – 1 Executive Summary Yes
5.2 2.1 Descriptive information of the device Yes
5.2 2.2 Product Specification Yes
2.3 Reference to predicate or previous
5.2 Yes
generations of the device
Part – 2 Device Description and product
5.2 specifications, including variants and Yes
accessories
Part – 3 Labelling Details (Labels and
5.3 Yes
Instruction for Use)
Part – 4 Device Design and Manufacturing
5.4 Yes
Information
5.5 Part – 5 Essential Principles Checklist Yes
5.6 Part – 6 Risk analysis and control summary Yes
5.7 7.10 Post Marketing Surveillance data Yes
5.7 7.1 Design verification and validation Yes
5.7 7.2 Biocompatibility validation data Yes
7.3 Medicinal substances data (if device
5.7 Yes
contains Drug)
5.7 7.4 Biological Safety Yes
5.7 7.5 Sterilization Validation data Yes
7.6 Software verification and validation (if
5.7 Yes
software used)
5.7 7.7 Animal studies – Preclinical data Yes
5.7 7.8 Stability validation data Yes
5.7 7.9 Clinical evidence Yes
Part – 7 Verification and validation of the
5.7 Yes
medical device
Part – 8 Batch Release Certificates or
5.8 Certificate of Analysis of finished product for Yes
minimum 3 consecutive batches
5.9 Part 9 Any other additional documents Yes
Detailed breakup of the fees deposited in
6.0 terms of site, risk class of the device and Yes
Medical device grouping etc.
Test License obtained for testing and
6.0 Yes
generation of quality control data
Undertaking from manufacturer (loan
7.0 licensee) stating that there is no change in Yes
the Constitution of the Firm.
Undertaking signed stating that the
7.0 manufacturing site is in compliance with Yes
provison of Fifth schedule
An undertaking from the manufacturer
8.0 (parent firm) stating that there is no major Yes
change(s) in the existing Device Master File
(DMF) and Plant Master File (PMF)
8.0 Fee Chalan Yes
9.0 Legal Form Yes
Qualification, experience and responsibilities
9.0 Yes
of current competent Technical staff.
Post marketing surveillance data (Vigilance
10.0 reporting) during last 5 yrs (details of Yes
complaints, recall (if any), CAPA taken, etc),
duly authenticated by the manufacturer.
11.0 Any other additional documents. Yes
Post Approval Changes taken due to change
12.0 in name and/or address of the firm, product Yes
details (if any)
13.0 Duly Signed Retention Form Yes
14.0 Fee Challan Yes
