CHECKLIST

Form Name: Form MD-7

Category: MD
FRESH

Section no. Checklist Name Is Mandatory

1.0 Covering Letter Yes

1. Constitution of the Firm Yes

1
The Establishment /Site ownership /Tenacy
1.2 Yes
Agreement
Copy of Duly notarized valid copies of Quality
2.0 No
Certificate in respect manufcturing site(s), if
any
Copy of Certificate supporting quality
2.1 Yes
management system (ISO: 13485), if any
Plant Master file from the Manufacturer as
3.0 No
specified in Appedix 1 of Forth Schedule of
Medical Devices Ruless
Part – 1 Plant Layout of premise with
3.1 Yes
indication of scale
Part – 2 Organisation chart showing the
3.2 No
arrangements for key personnel
Part – 3 Qualification, Experience and
3.3 No
responsibilities of key Technical Persons

3.4 Part – 4 List of Equipment and Instruments No

3.5 Part – 5 Contract Activities if any No

4.0 Quality Management System No

Part – 1 Quality Management System as per

4.1 Yes
Fifth Schedule of Medical devices Rules, 2017

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 Yes
needs and ensure that all persons are trained
to adequately perform their assigned
responsibilities.
Part – 10 Table the areas showing the
4.10 Yes
environmental requirement for Medical
Devices as per Annexure A of Fifth Schedule
of Medical devices Rules, 2017.
Device Master file from the Manufacturer as
5.0 No
specified in Appendix II (only for Medical
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.

5.1 Part – 1 Executive Summary Yes

5.2 2.1 Descriptive information of the device No

5.2 2.2 Product Specification No

2.3 Reference to predicate or previous

5.2 No
generations of the device
Part – 2 Device Description and product
5.2 No
specifications, including variants and
accessories
Part – 3 Labelling Details (Labels and
5.3 No
Instruction for Use)
Part – 4 Device Design and Manufacturing
5.4 No
Information

5.5 Part – 5 Essential Principles Checklist No

5.6 Part – 6 Risk analysis and control summary No

5.7 7.10 Post Marketing Surveillance data No

5.7 7.1 Design verification and validation No

5.7 7.2 Biocompatibility validation data No

 7.3 Medicinal substances data (if device
5.7 No
contains Drug)

5.7 7.4 Biological Safety No

5.7 7.5 Sterilization Validation data No

7.6 Software verification and validation (if

5.7 No
software used)

5.7 7.7 Animal studies – Preclinical data No

5.7 7.8 Stability validation data No

5.7 7.9 Clinical evidence No

Part – 7 Verification and validation of the

5.7 No
medical device
Part – 8 Batch Release Certificates or
5.8 No
Certificate of Analysis of finished product for
minimum 3 consecutive batches

5.9 Part 9 Any other additional documents No

Test License obtained for testing and

6.0 Yes
generation of quality control data
Undertaking signed stating that the
7.0 Yes
manufacturing site is in compliance with
provison of Fifth schedule

8.0 Fee Chalan Yes

9.0 Legal Form Yes

ENDORSEMENT

Section no. Checklist Name Is Mandatory

1.0 Covering Letter Yes

1. Constitution of the Firm Yes

1
The Establishment /Site ownership /Tenacy
1.2 Yes
Agreement
Copy of Duly notarized valid copies of
2.0 No
Quality Certificate in respect manufcturing
site(s), if any
 Copy of Certificate supporting quality
2.1 Yes
management system (ISO: 13485), if any
Plant Master file from the Manufacturer as
3.0 No
specified in Appedix 1 of Forth Schedule of
Medical Devices Ruless
Part – 1 Plant Layout of premise with
3.1 Yes
indication of scale
Part – 2 Organisation chart showing the
3.2 No
arrangements for key personnel
Part – 3 Qualification, Experience and
3.3 No
responsibilities of key Technical Persons

3.4 Part – 4 List of Equipment and Instruments No

3.5 Part – 5 Contract Activities if any No

4.0 Quality Management System No

Part – 1 Quality Management System as per

4.1 Yes
Fifth Schedule of Medical devices Rules,
2017

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 Yes
needs and ensure that all persons are
trained to adequately perform their assigned
responsibilities.
Part – 10 Table the areas showing the
4.10 Yes
environmental requirement for Medical
Devices as per Annexure A of Fifth Schedule
of Medical devices Rules, 2017.
 Device Master file from the Manufacturer as
5.0 No
specified in Appendix II (only for Medical
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.

5.1 Part – 1 Executive Summary Yes

5.2 2.1 Descriptive information of the device No

5.2 2.2 Product Specification No

2.3 Reference to predicate or previous

5.2 No
generations of the device
Part – 2 Device Description and product
5.2 No
specifications, including variants and
accessories
Part – 3 Labelling Details (Labels and
5.3 No
Instruction for Use)
Part – 4 Device Design and Manufacturing
5.4 No
Information

5.5 Part – 5 Essential Principles Checklist No

5.6 Part – 6 Risk analysis and control summary No

5.7 7.10 Post Marketing Surveillance data No

5.7 7.1 Design verification and validation No

5.7 7.2 Biocompatibility validation data No

7.3 Medicinal substances data (if device

5.7 No
contains Drug)

5.7 7.4 Biological Safety No

5.7 7.5 Sterilization Validation data No

7.6 Software verification and validation (if

5.7 No
software used)

5.7 7.7 Animal studies – Preclinical data No

5.7 7.8 Stability validation data No

 5.7 7.9 Clinical evidence No

Part – 7 Verification and validation of the

5.7 No
medical device
Part – 8 Batch Release Certificates or
5.8 No
Certificate of Analysis of finished product
for minimum 3 consecutive batches

5.9 Part 9 Any other additional documents No

Test License obtained for testing and

6.0 Yes
generation of quality control data
Undertaking signed stating that the
7.0 Yes
manufacturing site is in compliance with
provison of Fifth schedule

8.0 Fee Chalan Yes

9.0 Legal Form Yes

RETENTION

Section no. Checklist Name Is Mandatory

1.0 Covering Letter Yes

1. Constitution of the Firm Yes

1
The Establishment /Site ownership /Tenacy
1.2 Yes
Agreement
Copy of Duly notarized valid copies of Quality
2.0 No
Certificate in respect manufcturing site(s), if
any
Copy of Certificate supporting quality
2.1 Yes
management system (ISO: 13485), if any
Plant Master file from the Manufacturer as
3.0 No
specified in Appedix 1 of Forth Schedule of
Medical Devices Ruless
Part – 1 Plant Layout of premise with
3.1 Yes
indication of scale
Part – 2 Organisation chart showing the
3.2 No
arrangements for key personnel
Part – 3 Qualification, Experience and
3.3 No
responsibilities of key Technical Persons
3.4 Part – 4 List of Equipment and Instruments No

3.5 Part – 5 Contract Activities if any No

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 Yes
needs and ensure that all persons are trained
to adequately perform their assigned
responsibilities.
Part – 10 Table the areas showing the
4.10 Yes
environmental requirement for Medical
Devices as per Annexure A of Fifth Schedule
of Medical devices Rules, 2017.
Device Master file from the Manufacturer as
5.0 No
specified in Appendix II (only for Medical
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.

5.1 Part – 1 Executive Summary Yes

5.2 2.1 Descriptive information of the device No

5.2 2.2 Product Specification No

2.3 Reference to predicate or previous

5.2 No
generations of the device
Part – 2 Device Description and product
5.2 No
specifications, including variants and
accessories
 Part – 3 Labelling Details (Labels and
5.3 No
Instruction for Use)
Part – 4 Device Design and Manufacturing
5.4 No
Information

5.5 Part – 5 Essential Principles Checklist No

5.6 Part – 6 Risk analysis and control summary No

5.7 7.10 Post Marketing Surveillance data No

5.7 7.1 Design verification and validation No

5.7 7.2 Biocompatibility validation data No

7.3 Medicinal substances data (if device

5.7 No
contains Drug)

5.7 7.4 Biological Safety No

5.7 7.5 Sterilization Validation data No

7.6 Software verification and validation (if

5.7 No
software used)

5.7 7.7 Animal studies – Preclinical data No

5.7 7.8 Stability validation data No

5.7 7.9 Clinical evidence No

Part – 7 Verification and validation of the

5.7 No
medical device
Part – 8 Batch Release Certificates or
5.8 No
Certificate of Analysis of finished product for
minimum 3 consecutive batches

5.9 Part 9 Any other additional documents No

Test License obtained for testing and

6.0 Yes
generation of quality control data
Undertaking signed stating that the
7.0 Yes
manufacturing site is in compliance with
provison of Fifth schedule

8.0 Fee Chalan Yes

9.0 Legal Form Yes