English — complete six-page official static IVD checklist; original images and qualified native search text

CHECKLIST Form Name: Form MD-14 Category: IVD FRESH Section no. Checklist Name Is Mandatory 1.0 Covering Letter, Yes Power of Attorney (Original) authenticated in India either by a 2.0 Magistrate of First Class or by Indian Embassy in the country of Yes origin or by an equivalent authority through apostille along with under taking from the authorized agent as specified in Part I of Forth Schedule, Self-attested copy of valid Whole sale licence or manufacturing 3.0 Yes licence if any, Regulatory Certificates along with previous import license.(if any) 4.0 No Notarized copy of overseas manufacturing 4.1 site or establishment or plant registration, by whatever name Yes called, in the country of origin issued by the competent authority, Notarized and valid copy of Free Sale 4.2 Certificate issued by the National Regulatory Authority or Yes equivalent competent authority of the country of origin.(if any) Notarized and valid copy of Free Sale 4.3 Certificate issued by the National Regulatory Authority or Yes equivalent competent authority of the any of the countries namely United States of America, Australia, Canada, Japan, and European Union Countries. copy of latest inspection or audit report 4.4 carried out by Notified bodies or National Regulatory Authority or Yes Competent Authority within last 3 years, if any. copy of NOC from Department of Animal Husbandry, Ministry of 4.5 Agriculture, In Case of Veterinary IVD Kits, Yes copy of NOC from Bhabha Atomic Research Centre (BARC), 4.6 Mumbai, In case Radio Immuno Assay Kits, Yes Quality Management System certificate in respect of legal and 5.0 actual manufacturing sites(s) (Wherever applicable), No Notarized and valid copy of Quality 5.1 Management System certificate (ISO 13485) certificate issued by Yes the competent authority, Notarized and valid copy of Production 5.2 Quality Assurance certificate or Full quality Assurance certificate Yes issued by the competent authority.(if any)

Notarized and valid copy of CE design certificate issued by the 5.3 competent authority.(if any), Yes Site or plant master file as specified in Appendix I of Fourth 6.0 No Schedule of MDR 2017., 6.1 Part 1, Yes 6.2 Part 2, Yes 6.3 Part 3, Yes 6.4 Part 4, Yes Device Master File for In Vitro Diagnostic 7.0 Medical Devices as per Appendix – III of Part III of Fourth Schedule No of Medical devices Rules, 2017 Part-1 Executive Summary, Description and specification, 7.1 including variants and accessories and Design & manufacturing Yes information of the in vitro diagnostic medical device Part-2 Regulatory status of the similar device in India (approved or 7.2 new in vitro diagnostic medical device). Yes 7.3 Part – 3 Essential principles checklist Yes Part – 4 Risk analysis and control summary, Product validation 7.4 and verification and Clinical Evidences Yes Part-5 Analytical studies, Specimen type, 7.5 Analytical performance characteristics, Analytical sensitivity, Yes Analytical Specificity, Metrological traceability of calibrator and control material values, Measuring range of assay, Definition of assay Part – 6 Claimed Shelf life – stability study 7.6 report for at least 3 lots including the protocol, acceptance criteria, Yes testing intervals and conclusion, In use stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion & Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion. 7.7 Part-7 Product Insert, Pack size, Label Yes Part-8 Specimen batch test report for at least consecutive 3 batches 7.8 showing specification of each testing parameter Yes

Part-9 Copy of performance evaluation 7.9 report issued by the central medical device testing laboratory or Yes medical device testing laboratory registered under sub-rule (3) of rule 83 of MDR 2017 for three batches/ Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the in-vitro diagnostic medical device Part-10 Post Market Surveillance Data and any other information 7.10 Yes of the product Correlation chart with respect to products list mentioned in MD-14 8.0 Yes and FSC submitted, Testing method preferably in Video (if available), 9.0 Yes 10.0 Fee Challan Yes 11.0 Legal Form Yes ENDORSEMENT Section no. Checklist Name Is Mandatory 1.0 Covering Letter, Yes Power of Attorney (Original) authenticated in India either by a 2.0 Magistrate of First Class or by Indian Embassy in the country of Yes origin or by an equivalent authority through apostille along with under taking from the authorized agent as specified in Part I of Forth Schedule, Self-attested copy of valid Whole sale licence or manufacturing 3.0 Yes licence if any, Regulatory Certificates along with previous import license. 4.0 No Notarized and valid copy of Free Sale Certificate issued by the 4.1 National Regulatory Authority or equivalent competent authority of Yes the country of origin.(if any) Notarized and valid copy of Free Sale 4.2 Certificate issued by the National Regulatory Authority or Yes equivalent competent authority of the any of the countries namely United States of America, Australia, Canada, Japan, and European Union Countries. copy of latest inspection or audit report carried out by Notified 4.3 bodies or National Regulatory Authority or Competent Authority Yes within last 3 years, if any. copy of NOC from Department of Animal Husbandry, Ministry of 4.4 Agriculture, In Case of Veterinary IVD Kits, Yes copy of NOC from Bhabha Atomic Research Centre (BARC), 4.5 Mumbai, In case Radio Immuno Assay Kits, Yes

Quality Management System certificate in respect of legal and 5.0 actual manufacturing sites(s) (Wherever applicable), No Notarized and valid copy of Quality Management System certificate 5.1 (ISO 13485) certificate issued by the competent authority, Yes Notarized and valid copy of Production Quality Assurance 5.2 certificate or Full quality Assurance certificate issued by the Yes competent authority.(if any) Notarized and valid copy of CE design 5.3 certificate issued by the competent authority. (if any), Yes Device Master File for In Vitro Diagnostic 6.0 Medical Devices as per Appendix – III of Part III of Fourth No Schedule of Medical devices Rules, 2017 Part-1 Executive Summary, Description and specification, 6.1 including variants and accessories and Design & manufacturing Yes information of the in vitro diagnostic medical device Part-2 Regulatory status of the similar device 6.2 in India (approved or new in vitro diagnostic medical device). Yes 6.3 Part – 3 Essential principles checklist Yes Part-4 Risk analysis and control summary, 6.4 Product validation and verification and Clinical Evidences Yes Part-6 Claimed Shelf life – stability study 6.5 report for at least 3 lots including the protocol, acceptance criteria, Yes testing intervals and conclusion, In use stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion & Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion. Part-5 Analytical studies, Specimen type, 6.6 Analytical performance characteristics, Analytical sensitivity, Yes Analytical Specificity, Metrological traceability of calibrator and control material values, Measuring range of assay, Definition of assay 6.7 Part-7 Product Insert, Pack size, Label Yes Part-8 Specimen batch test report for at least consecutive 3 6.8 batches showing specification of each testing parameter Yes Part-9 Copy of performance evaluation report issued by the central 6.9 medical device testing laboratory or medical device testing Yes laboratory registered under sub-rule (3) of rule 83 of MDR 2017 for three batches/ Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the in-vitro diagnostic medical device Part-10 Post Market Surveillance Data and any other information 6.10 Yes of the product Correlation chart with respect to products list mentioned in MD-14 7.0 Yes and FSC submitted, Testing method preferably in Video (if available), 8.0 Yes

9.0 Fee Challan Yes 10.0 Legal Form Yes RETENTION Mandatory Section no. Checklist Name or not 1.0 Covering letter with purpose of application Yes 2.0 Base licence no., issue date Yes 3.0 End. No.1,2,3,4,5,6... Yes 4.0 Copy of earlier licences and endorsements. Yes If applicant intends to remove any of the 5.0 medical device which are approved under the said Yes license/endorsement, then the reason thereof shall be given. Fees breakup as per the class and no. of 6.0 products including manufacturing site & late fees if any. Yes An undertaking duly signed and stamped by 7.0 the manufacturer, that there is no change in Device master file Yes (DMF) and Plant master file (PMF). Post marketing surveillance data (Vigilance 8.0 reporting) during last 5 yrs. including the details of complaints Yes received, recall if any and CAPA, if initiated, duly signed and stamped by authorized agent or manufacturer. Valid Free Sale Certificate/Marketing Authorization of the product 9.0 from National Regulatory Authority of country of origin (if any) and Yes Free Sale Certificate/Marketing Authorization of the product from National Regulatory Authority of any of the following countries viz USA, EU, UK, Canada, Japan, Australia. Sales data of each device in India during last 5 yrs. 10.0 Yes Valid copies of Quality Certificate ISO 13485 and CE design 11.0 Yes certificate, if applicable. An undertaking duly signed and stamped with designation by the 12.0 manufacturer and authorized agent, stating that they are agreed for Yes further retention of the Import License No, if applicable. Undertaking duly signed and stamped by the manufacturer and 13.0 authorized Indian agent stating that there is no change in the Yes Power of Attorney (POA). In case any change in a copy of fresh Power of Attorney (Original) as specified in Part I of Forth Schedule may be submitted. Undertaking from the foreign manufacturer 14.0 that there is no change in the Certificate of Incorporation. Yes

Undertaking stating that they shall submit the 15.0 requisite fees for all the products endorsed in the base license Yes before completion of the five years from the date of issue of the base license. For this purpose, the portal may have option for the applicant 16.0 Post Approval Change Application (If Any) Yes 17.0 Bharat kosh receipt Yes 18.0 Duly Signed Retention Form Yes