English — original official blank checklist

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 2.0 in India either by a Magistrate of First Class Yes 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, Self attested copy of valid Whole sale licence 3.0 Yes or manufacturing licence if any, Regulatory Certificates along with previous 4.0 No import license.(if any) Notarized copy of overseas manufacturing 4.1 site or establishment or plant registration, by Yes whatever name 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 Yes Authority or 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 Yes Authority or 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 Yes Regulatory Authority or Competent Authority within last 3 years, if any. copy of NOC from Department of Animal 4.5 Husbandry, Ministry of Agriculture, In Case Yes of Veterinary IVD Kits, copy of NOC from Bhabha Atomic Research 4.6 Centre (BARC), Mumbai, In case Radio Yes Immuno Assay Kits, Quality Management System certificate in 5.0 respect of legal and actual manufacturing No sites(s) (Wherever applicable), Notarized and valid copy of Quality 5.1 Management System certificate (ISO 13485) Yes certificate issued by the competent authority, Notarized and valid copy of Production 5.2 Quality Assurance certificate or Full quality Yes Assurance certificate issued by the competent authority.(if any)

Notarized and valid copy of CE design 5.3 certificate issued by the competent Yes authority.(if any), Site or plant master file as specified in 6.0 No Appendix I of Fourth 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 No III of Fourth Schedule of Medical devices Rules, 2017 Part-1 Executive Summary, Description and 7.1 specification, including variants and Yes accessories and Design & manufacturing information of the in vitro diagnostic medical device Part-2 Regulatory status of the similar device 7.2 in India (approved or new in vitro diagnostic Yes medical device). 7.3 Part – 3 Essential principles checklist Yes Part – 4 Risk analysis and control summary, 7.4 Product validation and verification and Yes Clinical Evidences Part-5 Analytical studies, Specimen type, 7.5 Analytical performance characteristics, Yes Analytical sensitivity, 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 Yes protocol, acceptance criteria, 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 7.8 consecutive 3 batches showing specification Yes of each testing parameter

Part-9 Copy of performance evaluation 7.9 report issued by the central medical device Yes testing laboratory or 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 7.10 Yes any other information of the product Correlation chart with respect to products 8.0 Yes list mentioned in MD-14 and FSC submitted, Testing method preferably in Video (if 9.0 Yes available), 10.0 Fee Chalan Yes 11.0 Legal Form Yes ENDORSEMENT Mandatory or Section no. Checklist Name NO RECORD FOUND not 1.0 Covering Letter, Yes Power of Attorney (Original) authenticated in 2.0 India either by a Magistrate of First Class or Yes 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, Self attested copy of valid Whole sale licence 3.0 Yes or manufacturing licence if any, Regulatory Certificates along with previous 4.0 No import license. Notarized and valid copy of Free Sale 4.1 Certificate issued by the National Regulatory Yes Authority or equivalent competent authority of the country of orgin.(if any) Notarized and valid copy of Free Sale 4.2 Certificate issued by the National Regulatory Yes Authority or 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 4.3 carried out by Notified bodies or National Yes Regulatory Authority or Competent Authority within last 3 years, if any. copy of NOC from Department of Animal 4.4 Husbandry, Ministry of Agriculture, In Case of Yes Veterinary IVD Kits, copy of NOC from Bhabha Atomic Research 4.5 Centre (BARC), Mumbai, In case Radio Yes Immuno Assay Kits,

Quality Management System certificate in 5.0 respect of legal and actual manufacturing No sites(s) (Wherever applicable), Notarized and valid copy of Quality 5.1 Management System certificate (ISO 13485) Yes certificate issued by the competent authority, Notarized and valid copy of Production 5.2 Quality Assurance certificate or Full quality Yes Assurance certificate issued by the competent authority.(if any) Notarized and valid copy of CE design 5.3 certificate issued by the competent authority. Yes (if any), Device Master File for In Vitro Diagnostic 6.0 Medical Devices as per Appendix – III of Part No III of Fourth Schedule of Medical devices Rules, 2017 Part-1 Executive Summary, Description and 6.1 specification, including variants and Yes accessories and Design & manufacturing 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 Yes medical device). 6.3 Part – 3 Essential principles checklist Yes Part-4 Risk analysis and control summary, 6.4 Product validation and verification and Yes Clinical Evidences Part-6 Claimed Shelf life – stability study 6.5 report for at least 3 lots including the Yes protocol, acceptance criteria, 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, Yes Analytical sensitivity, 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 6.8 consecutive 3 batches showing specification Yes of each testing parameter Part-9 Copy of performance evaluation 6.9 report issued by the central medical device Yes testing laboratory or 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 6.10 Yes any other information of the product Correlation chart with respect to products list 7.0 Yes mentioned in MD-14 and FSC submitted, Testing method preferably in Video (if 8.0 Yes available),

9.0 Fee Chalan Yes 10.0 Legal Form Yes RETENTION Mandatory or Section no. Checklist Name not Copy of the license and its covering letter, 1.0 along with a copy of post approval changes to Yes the license (if any), and the wholesale/ manufacturing license of the authorized agent Copy of license and its covering letter, along 2.0 with a copy of Conditional fulfillment (if any), Yes and product/license surrender copy (if any) Valid Free Sale Certificate/Marketing 3.0 Authorization of the product from National Yes Regulatory Authority of country of origin (if any) and 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. Copy of Certificate supporting Quality 4.0 Management System, Full Quality Assurance Yes Certificate/ CE type examination Certificate/ CE product quality assurance certificate, CE design Certificate, DOC etc., An undertaking from the manufacturer 5.0 stating that there is no change(s) in the Yes existing Device Master File (DMF), Plant Master File (PMF) and Constitution of the firm Post marketing surveillance data (Vigilance 6.0 reporting) during last 5 yrs. (details of Yes complaints, recall from any country (if any), CAPA taken, etc), duly authenticated by the manufacturer or authorized agent. Undertaking duly signed and stamped by the 7.0 manufacturer and authorized Indian agent Yes stating that there is no change in the 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. 8.0 Duly Signed Retention Form Yes 9.0 Bharat kosh receipt Yes