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CHECKLIST Form Name: Post Approval Change application for Import License (Form MD- 14) Category: Change in respect of material of construction Section no. Checklist Name Is Mandatory 1. Application for PAC Yes 2. Comparative statement between existing and proposed material of Yes construction along with justification/rationale for proposed change 3. Upload existing Import License and its retention along with covering letter (if Yes applicable) 4. Revised Label, Instruction For Use, package insert, product manual with Yes proposed change (if applicable) 5. Batch Release Certificates or Certificate of Analysis of finished Yes product for minimum three consecutive batches 6. Notarized copy of approval obtained from National Regulatory Yes Authority/Notified body for proposed change (if any) 7. Copy of the relevant amendment in the Device Master File along with Essential Yes Principles Checklist of the device 8. Risk Management report on the device Yes 9. Stability study report (if applicable) Yes 10. Biocompatibility data (if applicable) No 11. Other document, if any No

Category: Change of address of the overseas legal manufacturer (without change in the constitution) Section no. Checklist Name Is Mandatory 1. Application for PAC Yes 2. Reason for proposed change Yes 3. Upload existing Import License and its retention if applicable No 4. Copy of Power of Attorney along with undertaking from authorized agent duly Yes authenticated in India either by a Magistrate of First Class or by Indian Embassy in the country of origin or by an equivalent authority through Apostille 5. Legal undertaking from the Yes manufacturer stating that there is no change in the Constitution of Overseas Manufacturer, except the address of the manufacturer and the same may be read in place of previous address in all Technical documents submitted at the time of grant of license. 6. Notarized copy of overseas Yes manufacturing site or establishment or plant registration from the country of origin issued by competent of the country 7. Notarized copy of Free Sale Certificate Yes issued by the national regulatory authority or other competent authority of any of the countries namely, USA, EU, UK, Canada, Australia or Japan 8. Notarised copy of all Quality certificates Yes (ISO 13485, CE Certificate, etc) with change in name 9. Other document, if any No

Category: Change of address of the overseas actual manufacturer (without change in the location and constitution) Section no. Checklist Name Is Mandatory 1. Application for PAC Yes 2. Reason for proposed change Yes 3. Upload existing Import License and its Yes retention if applicable 4. Copy of Power of Attorney along with Yes undertaking from authorized agent duly authenticated in India either by a Magistrate of First Class or by Indian Embassy in the country of origin or by an equivalent authority through Apostille 5. Legal undertaking from the Yes manufacturer stating that there is no change in the Constitution of Overseas Manufacturer, except the address of the manufacturer and the same may be read in place of previous address in all Technical documents submitted at the time of grant of license. 6. Notarized copy of overseas Yes manufacturing site or establishment or plant registration from the country of origin issued by competent of the country 7. Notarized copy of Free Sale Certificate Yes issued by the national regulatory authority or other competent authority of any of the countries namely, USA, EU, UK, Canada, Australia or Japan 8. Notarised copy of all Quality certificates Yes (ISO 13485, CE Certificate, etc) with change in name 9. Other document, if any No

Category: Change in respect of model number of the devices Section no. Checklist Name Is Mandatory 1. Application for PAC Yes 2. Details of proposed model number of Yes the device 3. Comparative statement between Yes existing and proposed model number along with justification/rationale for addition of model number 4. Upload existing Import License and its Yes retention if applicable 5. Reference to predicate or similar device Yes available in the country 6. Copy of the relevant amendment in the Yes Device Master File along with Essential Principles Checklist of the device 7. Risk Management report on proposed Yes model number of the device 8. Labelling information of proposed Yes model number of the device 9. Test reports as per applicable Yes standards 10. Batch Release Certificates or Yes Certificate of Analysis of finished product for minimum three consecutive batches 11. Notarized copy of Free Sale Certificate Yes issued by the national regulatory authority or other competent authority of any of the countries namely, USA, EU, UK, Canada, Australia or Japan 12. Notarized copy of all Quality certificates Yes (ISO 13485, CE Certificate, etc) 13. Other relevant document (if any) No

Category: Change in respect of Accessories / components of the devices Section no. Checklist Name Is Mandatory 1. Application for PAC Yes 2. Details of proposed accessories of the Yes parent device 3. Comparative statement between Yes existing and proposed accessories along with justification/rationale for addition of accessories to the parent device 4. Upload existing Manufacturing License Yes and its retention if applicable 5. Copy of the Device Master File Yes highlighting the proposed accessories 6. Risk Management report of the parent Yes device with respect to the proposed accessories 7. Copy of Instructions for use/ User Yes manual/ Package insert highlighting the proposed accessories 8. Notarized copy of Free Sale Certificate Yes issued by the national regulatory authority or other competent authority of any of the countries namely, USA, EU, UK, Canada, Australia or Japan 9. Other relevant document (if any) No Category: Change in respect of Primary packaging material Section no. Checklist Name Is Mandatory 1. Comparative statement between Yes existing and proposed primary packaging material along with justification/rationale for the change 2. Upload existing Import License and its Yes retention if applicable 3. Notarized copy of approval obtained Yes from National Regulatory Authority/Notified body for proposed changes (if any) 4. Risk Management report on the device Yes 5. Packaging and Sterilization validation Yes report (wherever applicable) 6. Batch Release Certificates or Yes Certificate of Analysis of finished product for minimum three consecutive batches 7. Accelerated stability and on-going real Yes time stability study data (if applicable) 8. Other document, if any No 9. Application for PAC Yes

Category: Change in the method of Sterilization Section no. Checklist Name Is Mandatory 1. Comparative statement between Yes existing and proposed method of sterilization along with justification/rationale for proposed changes 2. Upload existing Import License and its Yes retention if applicable 3. Revised Labelling information Yes (wherever applicable) 4. Copy of the relevant amendment in the Yes Device Master File 5. Risk Management report on the device Yes 6. Sterilization validation report Yes 7. Accelerated Stability study and On- Yes going real time stability study report 8. Batch Release Certificates or Yes Certificate of Analysis of finished product for minimum three consecutive batches 9. Notarized copy of approval obtained Yes from National Regulatory Authority/Notified body for proposed change (if any) 10. Other document, if any No 11. Application for PAC Yes

Category: Change of the approved Shelf Life Section no. Checklist Name Is Mandatory 1. Covering Letter, Yes 2. Justification/Rationale for Changes, Yes 3. Upload Old License, Yes 4. Labels and IFU, Yes 5. Comparative chart between Approved Yes and Proposed Shelf Life, 6. Stability study data of proposed IVDMD No made with the proposed composition / content , 6.1 Claimed Shelf life - stability study report Yes for at least 3 lots including the protocol, acceptance criteria, testing intervals and conclusion., 6.2 In use stability study report for 1 lot Yes including the protocol, acceptance criteria, testing intervals and conclusion 6.3 Shipping stability study report for 1 lot Yes including the protocol, acceptance criteria, simulated conditions, conclusion and recommended shipping conditions 7. Approval for the changes from National Yes Regulatory Authority or equivalent competent authority based upon whose Free sale certificate, Registration certificate/ Import license was obtained initially, 8. List of Countries where the proposed Yes change has been approved Regulatory Authority or equivalent competent authority , 9. Other documents, if any, No

Category: Change in the Intended use or indication for use Section no. Checklist Name Is Mandatory 1. Comparative statement of the existing Yes and proposed intended use of indication for use of the IVD Medical device along with justification /rationale for proposed change 2. Upload existing Import License and its Yes retention along with covering letter (if applicable) 3. Clinical evidence on proposed change Yes 4. Revised labelling and IFU information Yes 5. Reference to predicate or similar device Yes available in the market in respect of proposed intended use/indication for use 6. Copy of the relevant amendment in the Yes Device Master File along with Essential Principles Checklist of the device 7. Risk Management report on the device Yes 8. Notarized copy of approval obtained Yes from National Regulatory Authority/Notified body for proposed change 9. Other document, if any No 10. Application for PAC Yes

Category: Change in respect of design which shall affect quality in respect of its specifications, indication for use, performance and stability of the medical device Section no. Checklist Name Is Mandatory 1. Comparative statement between Yes existing and proposed design of the device along with justification/rationale for proposed change 2. Upload existing Import License and its Yes retention along with covering letter (if applicable) 3. Revised Labelling information (if any) No 4. Batch Release Certificates or Yes Certificate of Analysis of finished product for minimum three consecutive batches 5. Notarized copy of approval obtained Yes from National Regulatory Authority/Notified body for proposed change (if any) 6. Copy of the relevant amendment in the Yes Device Master File along with Essential Principles Checklist of the device 7. Risk Management report on the device, Yes 8. Stability study report (if applicable) No 9. Device design verification and Yes validation report 10. Other document, if any No 11. Application for PAC Yes

Category: Change in respect of Label excluding change in font size, font type, color, label design Section no. Checklist Name Is Mandatory 1. Comparative statement between existing and Yes proposed label of the device along with justification/rationale for proposed changes 2. Upload existing Import License and its No retention along with covering letter (if applicable) 3. Notarized copy of approval obtained from No National Regulatory Authority/Notified body for proposed changes (if any) 4. Copy of revised label of the device Yes 5. Packaging validation data (if applicable) No 6. Application for PAC Yes Category: Change in respect of the Instructions for Use or User manual or package insert Section Checklist Name Is Mandatory no. 1. Comparison between existing and proposed Yes Instructions for use/User manual/Package insert (highlighting the proposed changes) along with justification/rationale for proposed changes 2. Upload existing Import License and its retention Yes along with covering letter (if applicable) 3. Revised Instructions for use/User Yes manual/Package insert 4. Risk Management report on the device (if Yes applicable) 5. Notarized copy of approval obtained from Yes National Regulatory Authority/Notified body for proposed changes (if any) 6. Other document, if any No 7. Application for PAC Yes

Category: Change in respect of the manufacturing process, equipment or testing which shall affect quality of the device Section no. Checklist Name Is Mandatory 1. Comparative statement between existing and Yes new manufacturing process/ equipment/ testing along with justification/rationale for proposed changes 2. Upload existing Import License and its Yes retention if applicable 3. Notarized copy of approval obtained from Yes National Regulatory Authority/Notified body for proposed changes (if any) 4. Copy of the relevant amendment in the Yes Device Master File along with Essential Principles Checklist of the device 5. Quality Management System certificate Yes issued by the competent authority 6. Validation and verification data of new Yes manufacturing process/ equipment/ testing 7. Other document, if any No 8. Application for PAC Yes

Category: Change of name of the overseas manufacturer or its manufacturing site (without change in the constitution) Section no. Checklist Name Is Mandatory 1. Application for PAC Yes 2. Reason for proposed change Yes 3. Upload existing Import License and its Yes retention along with covering letter (if applicable) 4. Copy of Power of Attorney along with Yes undertaking from authorized agent duly authenticated in India either by a Magistrate of First Class or by Indian Embassy in the country of origin or by an equivalent authority through Apostille 5. Legal undertaking in 100 Rs Stamp No paper from the manufacturer stating that there is no change in the Constitution of Overseas Manufacturer, except the name of the manufacturer and the same may be read in place of previous name in all Technical documents submitted at the time of grant of license 6. Notarized copy of overseas Yes manufacturing site or establishment or plant registration from the country of origin issued by competent of the country 7. Notarized copy of Free Sale Certificate No issued by the national regulatory authority or other competent authority of any of the countries namely, USA, EU, UK, Canada, Australia or Japan 8. Notarised copy of all Quality certificates Yes (ISO 13485, CE Certificate, etc) with change in name 9. Revised Label, Instruction For Use, No package insert, product manual with proposed change (if applicable) 10. Revised Plant Master File with No proposed change

Category: Change of name of the authorized agent (Without change in the constitution) Section no. Checklist Name Is Mandatory 1. Covering Letter, Yes 2. Power of Attorney (Original) Yes authenticated in India either by a Magistrate of First Class or by Indian Embassy in the country of origin or by an equivalent authority through apostille along with under taking from the authorized agent as specified in Part I of Forth Schedule, 3. Constitution details of authorized agent, Yes 4. Upload Old License, Yes 5. Label and IFU and Labels with Indian Yes Specific details, 6. Self-attested copy of valid Whole sale Yes licence or manufacturing licence, 7. Other documents, if any, No Category: Change of address of the authorized agent (Without change in the constitution) Section no. Checklist Name Is Mandatory 1. Covering Letter, Yes 2. Power of Attorney (Original) authenticated Yes in India either by a Magistrate of First Class or by Indian Embassy in the country of origin or by an equivalent authority through apostille along with under taking from the authorized agent as specified in Part I of Forth Schedule, 3. Constitution details of authorized agent , Yes 4. Upload Old License, Yes 5. Labels and IFU, Yes 6. Self-attested of valid wholesale License or Yes manufacturing License, 7. Legal Form Yes

Category: Change in respect of design which shall not affect quality in respect of its specifications, indication for use, performance and stability of the medical device Section no. Checklist Name Is Mandatory 1. Comparative statement between Yes existing and proposed design of the device along with justification/rationale for proposed change 2. Upload existing Import License and its Yes retention along with covering letter (if applicable) 3. Revised Labelling information (if any) Yes 4. Batch Release Certificates or Yes Certificate of Analysis of finished product for minimum three consecutive batches 5. Notarized copy of approval obtained No from National Regulatory Authority/Notified body for proposed change (if any) 6. Copy of the relevant amendment in the Yes Device Master File along with Essential Principles Checklist of the device 7. Risk Management report on the device Yes 8. Stability study report (if applicable) Yes 9. Device design verification and Yes validation report 10. Other document, if any No 11. Application for PAC Yes

Category: Change in respect of the manufacturing process, equipment, or testing which shall not affect quality of the device Section no. Checklist Name Is Mandatory 1. Comparative statement between Yes existing and new manufacturing process/ equipment/ testing along with justification/rationale for proposed changes 2. Upload existing Import License and its Yes retention if applicable 3. Notarized copy of approval obtained Yes from National Regulatory Authority/Notified body for proposed changes (if any) 4. Copy of the relevant amendment in the Yes Plant Master File (if applicable) 5. Copy of the relevant amendment in the Yes Device Master File along with Essential Principles Checklist of the device 6. Validation and verification data of new Yes manufacturing process/ equipment/ testing 7. Other document, if any No 8. Application for PAC Yes Category: Change in respect of the packaging specifications excluding primary packaging material Section no. Checklist Name Is Mandatory 1. Comparative statement between Yes existing and proposed packaging specification along with justification/rationale for change 2. Upload existing Import License and its Yes retention along with covering letter (if applicable) 3. Copy of revised label and IFU of the Yes device (if applicable) 4. Risk Management report on the device Yes (if applicable) 5. Packaging validation data (if applicable) Yes 6. Other document, if any No 7. Application for PAC Yes 8. Copy of relevant amendment in the Yes Device Master File ( if applicable)

Category: Amendment / Correction/ Others Section no. Checklist Name Is Mandatory 1. Covering Letter Yes 2. Copy of earlier licence Yes 3. copy of earlier MD-14 Yes 4. proposed change/correction Yes 5. Reason/justification for change Yes 6. copy of earlier fee receipt Yes