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CDSCO License.pptx

This document outlines the application process and required documents for various medical device licenses from India's Central Drugs Standard Control Organization (CDSCO). It provides details on: 1. Medical device classification based on risk level into Classes A through D. 2. The application process and documents required for an import license, manufacturing license, loan manufacturing license for Classes A and B devices, and manufacturing license for Classes C and D devices. 3. The documents include regulatory certificates, quality management documentation, device master files, and other technical documents describing the device and quality systems.

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CDSCO APPLICATION CDSCO
Classification of Medical Device Medical Devices other than In Vitro Diagnostic Medical Devices shall be classified on the basis of parameters specified in part i of the first schedule, in the following classes: Class Risk Level Example A Low risk Thermometer B Low moderate risk Hypodermic Needle C Moderate high risk Lung Ventilator D High risk Heart Valves
Classification of In vitro Diagnostic Medical Devices In vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part II of the First Schedule, in the following classes: Class Risk Level Example A Low risk Clinical chemistry analyzer B Low moderate risk Pregnancy self test kit C Moderate high risk Blood glucose self kit D High risk HIV blood diagnostic/blood donor screening kit
MD-14 Application Documents Required For Import License: S. No. Documents 1. Covering Letter 2. Power of Attorney (Original) 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. Self-attested copy of valid wholesale license or manufacturing license 4. Regulatory Certificate 4.1 Duly apostilled/notarized copy of Free Sale Certificate/Marketing Authorization of the product from National Regulatory Authority of country of origin (if any) 4.1.1 Part 1
S. No. Documents 4.2 Duly apostilled/notarized copy of Free Sale Certificate Marketing Authorization of the product from National Regulatory Authority of any of the following countries viz USA, EU, Canada, Japan, Australia. 4.3 Copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within last 3 years, if any. 5. Notarized copy of Duly notarized valid copies of Quality Certificate in respect of the legal and actual manufacturing site (s) (wherever applicable) 5.1 Notarized copy of Certificate supporting quality management system (ISO: 13485) 5.2 Notarized Full quality Assurance Certificate/CE type examination Certificate/CE product quality assurance 5.3 Notarized CE design Certificate 5.4 Notarized Declaration of conformity 5.4.1 Part 1 6. Plant Master file from the Manufacturer as specified in Appendix 1 of Forth Schedule of Medical Devices Rules
S. No. Documents 7. Device Master file from the Manufacturer as specified in Appendix II (only for medical Devices) of Forth Schedule of Medical Devices Rules. 7.1 Part 1. Device Master File for Medical Devices as per Appendix II of Medical devices Rules, 2017 7.2 Part 2. Reference to predicate or previous generations of the device 7.3 Part 3. Label and IFU 7.4 Part 4. Device Design and Manufacturing process with flow chart 7.5 Part 5. Essential Principles Checklist 7.6 Part 6. Risk analysis and control summary 7.7 Part 7. Design Verification and validation of the medical device 7.8 Part 8 .Biocompatibility validation data 7.9 Part 9. Medicinal substances data if device contains Drug 7.10 Part 10. Biological Safety (TSE/BSE) 7.11 Part 11. Sterilization Validation data
S. No. Documents 7.12 Part 12. Software verification and validation if software used 7.13 Part 13. Animal studies Preclinical data 7.14 Part 14. Stability validation data 7.15 Part 15. Clinical evidence 7.16 Part 16. Post Marketing Surveillance data 7.17 Part 17. Batch Release Certificates or Certificate of Analysis of finished product for minimum 3 consecutive batches 7.18 Others(if any) 8. Notarized copy of overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority 9. Constitution details of domestic manufacturer or authorized agent require for Class B, C and D 10. Fee Challan 11. Legal Form
MD-3 Application Documents Required For Grant of License to Manufacture for Sale or Distribution of Class A & Class B (other than non-sterile): S. No. Documents 1. Covering Letter 1.1 Constitution Details of Manufacturer 1.2 The Establishment /Site ownership /Tenacy Agreement 2 Copy of Duly notarized valid copies of Quality Certificate in respect manufacturing site(s), if any 2.1 Copy of Certificate supporting quality management system (ISO: 13485), if any 3. Plant Master file from the Manufacturer as specified in Appendix 1 of Forth Schedule of Medical Devices Rules 4. Device Master file from the Manufacturer as 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.
S. No. Documents 5.1 Performance Evaluation Report of IVDs only -- Aortic Annuloplasty Device 6. Test License obtained for testing and generation of quality control data 7. Undertaking signed stating that the manufacturing site is in compliance with provision of Fifth schedule 8. Fee Challan 9. Legal Form
MD-4 Application Documents Required For Grant of Loan License to Manufacture for Sale or Distribution of Class A & Class B (other than non-sterile): S. No. Documents 1. Covering Letter 1.1 Constitution Details of Manufacturer 1.2 The Establishment /Site ownership /Tenacy Agreement 2 Copy of Duly notarized valid copies of Quality Certificate in respect manufacturing site(s), if any 2.1 Copy of Certificate supporting quality management system (ISO: 13485), if any 3. Plant Master file from the Manufacturer as specified in Appendix 1 of Forth Schedule of Medical Devices Rules 4. Device Master file from the Manufacturer as 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.
S. No. Documents 5.1 Performance Evaluation Report of IVDs only -- Aortic Annuloplasty Device 6. Test License obtained for testing and generation of quality control data 7. Undertaking signed stating that the manufacturing site is in compliance with provision of Fifth schedule 8. Fee Challan 9. Legal Form
MD-7 Application Documents Required For Grant of License to Manufacture for Sale or Distribution of Class C & Class D: S. No. Documents 1. Covering Letter 2. Constitution Details of Manufacturer, 3. Site or plant master file as specified in Appendix I of Fourth Schedule of MDR 2017. 3.1 Part – 1 Plant Layout of premise with indication of scale 3.2 Part – 2 Organization chart showing the arrangements for key personnel 3.3 Part – 3 Qualification, Experience and responsibilities of key Technical Persons 3.4 Part – 4 List of Equipment and Instruments 3.5 Part – 5 Contract Activities if any
S. No. Documents 4. Quality Management System 4.1 Part – 1 Quality Management System as per Fifth Schedule of Medical devices Rules, 2017 4.2 Part – 2 Quality Manual 4.3 Part – 3 Quality Policy 4.4 Part – 4 Control of Documents 4.5 Part – 5 Control of Records 4.6 Part – 6 Management Responsibility 4.7 Part – 7 Internal Audit System 4.8 Part – 8 Preventive and Corrective Action 4.9 Part – 9 Procedure for identifying training needs and ensure that all persons are trained to adequately perform their assigned responsibilities. 4.10 Part – 10 Table the areas showing the environmental requirement for Medical Devices as per Annexure A of Fifth Schedule of Medical devices Rules, 2017. 5. Undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule of MDR 2017
S. No. Documents 6. Regulatory certificates 6.1 copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within last 3 years .(if any) 6.2 copy of NOC from Department of Animal Husbandry, Ministry of Agriculture, In Case of Veterinary IVD Kits (if available) 6.3 copy of NOC from Bhabha Atomic Research Centre (BARC), Mumbai, In case Radio Immuno Assay Kits (if available) 6.4 valid copy of Quality Management System certificate (ISO:13485) certificate issued by the competent authority .(if any) 6.5 Copy of Test licence obtained for testing and generation of quality control data, if any 6.6 Self attested copy of valid Whole sale license or manufacturing license if any 7. Device Master File for In Vitro Diagnostic Medical Devices as per Appendix – III of Part III of Fourth Schedule of Medical devices Rules, 2017 7.1.1 Part – 1 Executive Summary -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.2 Part-2 Regulatory status of the similar device in India (approved or new in vitro diagnostic medical device). -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
S. No. Documents 7.1.3 Part-3 Description and specification, including variants and accessories of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.4 Part – 4 Essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the in vitro medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.5 Part – 5 Risk analysis and control summary - STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.6 Part – 6 Device Design and Manufacturing Information - STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.7 Part-7 Product validation and verification - STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.8 Part-8 Analytical studies, Specimen type, Analytical performance characteristics, Analytical sensitivity, Analytical Specificity, Metrological traceability of calibrator and control material values, Measuring range of assay, Definition of assay -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.9 Part – 9 Claimed Shelf life - stability study report for at least 3 lots including the protocol, acceptance criteria, testing intervals and conclusion. -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
S. No. Documents 7.1.10 Part-10 In use stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.11 Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.12 Part-12 Clinical Evidence -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.13 Part-13 Product Insert, Pack size, Label -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.14 Part-14 Specimen batch test report for at least consecutive 3 batches showing specification of each testing parameter -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.15 Part-15 Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
S. No. Documents 7.1.16 Part-16 Copy of performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of rule 83 of MDR 2017 for three batches -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.17 Part-17 Post Market Surveillance Data -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.18 Part-18-Others -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.1 Part – 1 Executive Summary -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.2 Part-2 Regulatory status of the similar device in India (approved or new in vitro diagnostic medical device). -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.3 Part-3 Description and specification, including variants and accessories of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.4 Part – 4 Essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the in vitro medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
S. No. Documents 7.2.5 Part – 5 Risk analysis and control summary -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.6 Part – 6 Device Design and Manufacturing Information -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.7 Part-7 Product validation and verification -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.8 Part-8 Analytical studies, Specimen type, Analytical performance characteristics, Analytical sensitivity, Analytical Specificity, Metrological traceability of calibrator and control material values, Measuring range of assay, Definition of assay -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.9 Part – 9 Claimed Shelf life - stability study report for at least 3 lots including the protocol, acceptance criteria, testing intervals and conclusion. -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.10 Part-10 In use stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
S. No. Documents 7.2.11 Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.12 Part-12 Clinical Evidence -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.13 Part-13 Product Insert, Pack size, Label -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.14 Part-14 Specimen batch test report for at least consecutive 3 batches showing specification of each testing parameter -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.15 Part-15 Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.16 Part-16 Copy of performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of rule 83 of MDR 2017 for three batches -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
S. No. Documents 7.2.17 Part-17 Post Market Surveillance Data -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.18 Part-18-Others -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 8. Fee Challan 9. Legal Form
MD-8 Application Documents Required For Grant of Loan License to Manufacture for Sale or Distribution of Class C & Class D: S. No. Documents 1. Covering Letter 2. Constitution Details of Manufacturer, 3. Site or plant master file as specified in Appendix I of Fourth Schedule of MDR 2017. 3.1 Part – 1 Plant Layout of premise with indication of scale 3.2 Part – 2 Organization chart showing the arrangements for key personnel 3.3 Part – 3 Qualification, Experience and responsibilities of key Technical Persons 3.4 Part – 4 List of Equipment and Instruments 3.5 Part – 5 Contract Activities if any
S. No. Documents 4. Quality Management System 4.1 Part – 1 Quality Management System as per Fifth Schedule of Medical devices Rules, 2017 4.2 Part – 2 Quality Manual 4.3 Part – 3 Quality Policy 4.4 Part – 4 Control of Documents 4.5 Part – 5 Control of Records 4.6 Part – 6 Management Responsibility 4.7 Part – 7 Internal Audit System 4.8 Part – 8 Preventive and Corrective Action 4.9 Part – 9 Procedure for identifying training needs and ensure that all persons are trained to adequately perform their assigned responsibilities. 4.10 Part – 10 Table the areas showing the environmental requirement for Medical Devices as per Annexure A of Fifth Schedule of Medical devices Rules, 2017. 5. Undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule of MDR 2017
S. No. Documents 6. Regulatory certificates 6.1 copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within last 3 years .(if any) 6.2 copy of NOC from Department of Animal Husbandry, Ministry of Agriculture, In Case of Veterinary IVD Kits (if available) 6.3 copy of NOC from Bhabha Atomic Research Centre (BARC), Mumbai, In case Radio Immuno Assay Kits (if available) 6.4 valid copy of Quality Management System certificate (ISO:13485) certificate issued by the competent authority .(if any) 6.5 Copy of Test licence obtained for testing and generation of quality control data, if any 6.6 Self attested copy of valid Whole sale license or manufacturing license if any 7. Device Master File for In Vitro Diagnostic Medical Devices as per Appendix – III of Part III of Fourth Schedule of Medical devices Rules, 2017 7.1.1 Part – 1 Executive Summary -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.2 Part-2 Regulatory status of the similar device in India (approved or new in vitro diagnostic medical device). -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
S. No. Documents 7.1.3 Part-3 Description and specification, including variants and accessories of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.4 Part – 4 Essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the in vitro medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.5 Part – 5 Risk analysis and control summary - STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.6 Part – 6 Device Design and Manufacturing Information - STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.7 Part-7 Product validation and verification - STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.8 Part-8 Analytical studies, Specimen type, Analytical performance characteristics, Analytical sensitivity, Analytical Specificity, Metrological traceability of calibrator and control material values, Measuring range of assay, Definition of assay -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.9 Part – 9 Claimed Shelf life - stability study report for at least 3 lots including the protocol, acceptance criteria, testing intervals and conclusion. -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
S. No. Documents 7.1.10 Part-10 In use stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.11 Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.12 Part-12 Clinical Evidence -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.13 Part-13 Product Insert, Pack size, Label -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.14 Part-14 Specimen batch test report for at least consecutive 3 batches showing specification of each testing parameter -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.15 Part-15 Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
S. No. Documents 7.1.16 Part-16 Copy of performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of rule 83 of MDR 2017 for three batches -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.17 Part-17 Post Market Surveillance Data -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.18 Part-18-Others -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.1 Part – 1 Executive Summary -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.2 Part-2 Regulatory status of the similar device in India (approved or new in vitro diagnostic medical device). -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.3 Part-3 Description and specification, including variants and accessories of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.4 Part – 4 Essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the in vitro medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
S. No. Documents 7.2.5 Part – 5 Risk analysis and control summary -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.6 Part – 6 Device Design and Manufacturing Information -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.7 Part-7 Product validation and verification -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.8 Part-8 Analytical studies, Specimen type, Analytical performance characteristics, Analytical sensitivity, Analytical Specificity, Metrological traceability of calibrator and control material values, Measuring range of assay, Definition of assay -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.9 Part – 9 Claimed Shelf life - stability study report for at least 3 lots including the protocol, acceptance criteria, testing intervals and conclusion. -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.10 Part-10 In use stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
S. No. Documents 7.2.11 Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.12 Part-12 Clinical Evidence -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.13 Part-13 Product Insert, Pack size, Label -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.14 Part-14 Specimen batch test report for at least consecutive 3 batches showing specification of each testing parameter -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.15 Part-15 Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.16 Part-16 Copy of performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of rule 83 of MDR 2017 for three batches -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
S. No. Documents 7.2.17 Part-17 Post Market Surveillance Data -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.18 Part-18-Others -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 8. Fee Challan 9. Legal Form
MD-14 Application Fees For Import License: S. No. Subject Fees 1. Import license for Class A (other than non-sterile and non-measuring) medical devices other than in vitro diagnostic medical devices for,- (a) one site; and (b) each distinct medical device. $1000 $50 2. Import license for Class B medical device other than in vitro diagnostic medical device for,- (a) one site; and (b) each distinct medical device. $2000 $1000 3. Import license for Class A (other than non-sterile and non-measuring) or Class B in vitro diagnostic medical device for,- (a) one site; and (b) each distinct in vitro diagnostic medical device. $1000 $10 4. Import license for Class C or Class D medical device other than in vitro diagnostic medical devices for,- (a) one site; and (b) each distinct medical device. $3000 $1500
S. No. Subject Fees 5. Import license for Class C or Class D in vitro diagnostic medical device for,- (a) one site; and (b) each distinct in vitro diagnostic medical device. $3000 $500 6. Manufacturing license or loan license to manufacture Class A (other than non-sterile and non-measuring) or Class B medical device for,- (a) one site; and (b) each distinct medical device. Rs. 5000 Rs. 500 7. Manufacturing license or loan license to manufacture Class C or Class D medical device for,- (a) one site; and (b) each distinct medical device. Rs. 50000 Rs. 1000 8. Manufacturing license or loan license retention fee for,- (a) one site manufacturing Class A (other than non-sterile and non-measuring) or Class B medical device; or (b) one site of manufacturing Class C or Class D medical device; or (c) each distinct medical device of Class A (other than non-sterile and non-measuring) or Class B; or (d) each distinct medical device of Class C or Class D. Rs. 5000 Rs. 50000 Rs. 500 Rs. 1000
CDSCO License.pptx

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CDSCO License.pptx

  • 1.
  • 2.
    Classification of MedicalDevice Medical Devices other than In Vitro Diagnostic Medical Devices shall be classified on the basis of parameters specified in part i of the first schedule, in the following classes: Class Risk Level Example A Low risk Thermometer B Low moderate risk Hypodermic Needle C Moderate high risk Lung Ventilator D High risk Heart Valves
  • 3.
    Classification of Invitro Diagnostic Medical Devices In vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part II of the First Schedule, in the following classes: Class Risk Level Example A Low risk Clinical chemistry analyzer B Low moderate risk Pregnancy self test kit C Moderate high risk Blood glucose self kit D High risk HIV blood diagnostic/blood donor screening kit
  • 4.
    MD-14 Application Documents RequiredFor Import License: S. No. Documents 1. Covering Letter 2. Power of Attorney (Original) 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. Self-attested copy of valid wholesale license or manufacturing license 4. Regulatory Certificate 4.1 Duly apostilled/notarized copy of Free Sale Certificate/Marketing Authorization of the product from National Regulatory Authority of country of origin (if any) 4.1.1 Part 1
  • 5.
    S. No. Documents 4.2 Dulyapostilled/notarized copy of Free Sale Certificate Marketing Authorization of the product from National Regulatory Authority of any of the following countries viz USA, EU, Canada, Japan, Australia. 4.3 Copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within last 3 years, if any. 5. Notarized copy of Duly notarized valid copies of Quality Certificate in respect of the legal and actual manufacturing site (s) (wherever applicable) 5.1 Notarized copy of Certificate supporting quality management system (ISO: 13485) 5.2 Notarized Full quality Assurance Certificate/CE type examination Certificate/CE product quality assurance 5.3 Notarized CE design Certificate 5.4 Notarized Declaration of conformity 5.4.1 Part 1 6. Plant Master file from the Manufacturer as specified in Appendix 1 of Forth Schedule of Medical Devices Rules
  • 6.
    S. No. Documents 7. DeviceMaster file from the Manufacturer as specified in Appendix II (only for medical Devices) of Forth Schedule of Medical Devices Rules. 7.1 Part 1. Device Master File for Medical Devices as per Appendix II of Medical devices Rules, 2017 7.2 Part 2. Reference to predicate or previous generations of the device 7.3 Part 3. Label and IFU 7.4 Part 4. Device Design and Manufacturing process with flow chart 7.5 Part 5. Essential Principles Checklist 7.6 Part 6. Risk analysis and control summary 7.7 Part 7. Design Verification and validation of the medical device 7.8 Part 8 .Biocompatibility validation data 7.9 Part 9. Medicinal substances data if device contains Drug 7.10 Part 10. Biological Safety (TSE/BSE) 7.11 Part 11. Sterilization Validation data
  • 7.
    S. No. Documents 7.12Part 12. Software verification and validation if software used 7.13 Part 13. Animal studies Preclinical data 7.14 Part 14. Stability validation data 7.15 Part 15. Clinical evidence 7.16 Part 16. Post Marketing Surveillance data 7.17 Part 17. Batch Release Certificates or Certificate of Analysis of finished product for minimum 3 consecutive batches 7.18 Others(if any) 8. Notarized copy of overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority 9. Constitution details of domestic manufacturer or authorized agent require for Class B, C and D 10. Fee Challan 11. Legal Form
  • 8.
    MD-3 Application Documents RequiredFor Grant of License to Manufacture for Sale or Distribution of Class A & Class B (other than non-sterile): S. No. Documents 1. Covering Letter 1.1 Constitution Details of Manufacturer 1.2 The Establishment /Site ownership /Tenacy Agreement 2 Copy of Duly notarized valid copies of Quality Certificate in respect manufacturing site(s), if any 2.1 Copy of Certificate supporting quality management system (ISO: 13485), if any 3. Plant Master file from the Manufacturer as specified in Appendix 1 of Forth Schedule of Medical Devices Rules 4. Device Master file from the Manufacturer as 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.
  • 9.
    S. No. Documents 5.1Performance Evaluation Report of IVDs only -- Aortic Annuloplasty Device 6. Test License obtained for testing and generation of quality control data 7. Undertaking signed stating that the manufacturing site is in compliance with provision of Fifth schedule 8. Fee Challan 9. Legal Form
  • 10.
    MD-4 Application Documents RequiredFor Grant of Loan License to Manufacture for Sale or Distribution of Class A & Class B (other than non-sterile): S. No. Documents 1. Covering Letter 1.1 Constitution Details of Manufacturer 1.2 The Establishment /Site ownership /Tenacy Agreement 2 Copy of Duly notarized valid copies of Quality Certificate in respect manufacturing site(s), if any 2.1 Copy of Certificate supporting quality management system (ISO: 13485), if any 3. Plant Master file from the Manufacturer as specified in Appendix 1 of Forth Schedule of Medical Devices Rules 4. Device Master file from the Manufacturer as 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.
  • 11.
    S. No. Documents 5.1Performance Evaluation Report of IVDs only -- Aortic Annuloplasty Device 6. Test License obtained for testing and generation of quality control data 7. Undertaking signed stating that the manufacturing site is in compliance with provision of Fifth schedule 8. Fee Challan 9. Legal Form
  • 12.
    MD-7 Application Documents RequiredFor Grant of License to Manufacture for Sale or Distribution of Class C & Class D: S. No. Documents 1. Covering Letter 2. Constitution Details of Manufacturer, 3. Site or plant master file as specified in Appendix I of Fourth Schedule of MDR 2017. 3.1 Part – 1 Plant Layout of premise with indication of scale 3.2 Part – 2 Organization chart showing the arrangements for key personnel 3.3 Part – 3 Qualification, Experience and responsibilities of key Technical Persons 3.4 Part – 4 List of Equipment and Instruments 3.5 Part – 5 Contract Activities if any
  • 13.
    S. No. Documents 4.Quality Management System 4.1 Part – 1 Quality Management System as per Fifth Schedule of Medical devices Rules, 2017 4.2 Part – 2 Quality Manual 4.3 Part – 3 Quality Policy 4.4 Part – 4 Control of Documents 4.5 Part – 5 Control of Records 4.6 Part – 6 Management Responsibility 4.7 Part – 7 Internal Audit System 4.8 Part – 8 Preventive and Corrective Action 4.9 Part – 9 Procedure for identifying training needs and ensure that all persons are trained to adequately perform their assigned responsibilities. 4.10 Part – 10 Table the areas showing the environmental requirement for Medical Devices as per Annexure A of Fifth Schedule of Medical devices Rules, 2017. 5. Undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule of MDR 2017
  • 14.
    S. No. Documents 6.Regulatory certificates 6.1 copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within last 3 years .(if any) 6.2 copy of NOC from Department of Animal Husbandry, Ministry of Agriculture, In Case of Veterinary IVD Kits (if available) 6.3 copy of NOC from Bhabha Atomic Research Centre (BARC), Mumbai, In case Radio Immuno Assay Kits (if available) 6.4 valid copy of Quality Management System certificate (ISO:13485) certificate issued by the competent authority .(if any) 6.5 Copy of Test licence obtained for testing and generation of quality control data, if any 6.6 Self attested copy of valid Whole sale license or manufacturing license if any 7. Device Master File for In Vitro Diagnostic Medical Devices as per Appendix – III of Part III of Fourth Schedule of Medical devices Rules, 2017 7.1.1 Part – 1 Executive Summary -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.2 Part-2 Regulatory status of the similar device in India (approved or new in vitro diagnostic medical device). -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
  • 15.
    S. No. Documents 7.1.3 Part-3Description and specification, including variants and accessories of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.4 Part – 4 Essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the in vitro medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.5 Part – 5 Risk analysis and control summary - STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.6 Part – 6 Device Design and Manufacturing Information - STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.7 Part-7 Product validation and verification - STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.8 Part-8 Analytical studies, Specimen type, Analytical performance characteristics, Analytical sensitivity, Analytical Specificity, Metrological traceability of calibrator and control material values, Measuring range of assay, Definition of assay -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.9 Part – 9 Claimed Shelf life - stability study report for at least 3 lots including the protocol, acceptance criteria, testing intervals and conclusion. -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
  • 16.
    S. No. Documents 7.1.10 Part-10In use stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.11 Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.12 Part-12 Clinical Evidence -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.13 Part-13 Product Insert, Pack size, Label -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.14 Part-14 Specimen batch test report for at least consecutive 3 batches showing specification of each testing parameter -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.15 Part-15 Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
  • 17.
    S. No. Documents 7.1.16 Part-16Copy of performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of rule 83 of MDR 2017 for three batches -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.17 Part-17 Post Market Surveillance Data -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.18 Part-18-Others -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.1 Part – 1 Executive Summary -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.2 Part-2 Regulatory status of the similar device in India (approved or new in vitro diagnostic medical device). -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.3 Part-3 Description and specification, including variants and accessories of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.4 Part – 4 Essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the in vitro medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
  • 18.
    S. No. Documents 7.2.5 Part– 5 Risk analysis and control summary -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.6 Part – 6 Device Design and Manufacturing Information -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.7 Part-7 Product validation and verification -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.8 Part-8 Analytical studies, Specimen type, Analytical performance characteristics, Analytical sensitivity, Analytical Specificity, Metrological traceability of calibrator and control material values, Measuring range of assay, Definition of assay -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.9 Part – 9 Claimed Shelf life - stability study report for at least 3 lots including the protocol, acceptance criteria, testing intervals and conclusion. -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.10 Part-10 In use stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
  • 19.
    S. No. Documents 7.2.11 Part-11Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.12 Part-12 Clinical Evidence -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.13 Part-13 Product Insert, Pack size, Label -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.14 Part-14 Specimen batch test report for at least consecutive 3 batches showing specification of each testing parameter -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.15 Part-15 Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.16 Part-16 Copy of performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of rule 83 of MDR 2017 for three batches -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
  • 20.
    S. No. Documents 7.2.17 Part-17Post Market Surveillance Data -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.18 Part-18-Others -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 8. Fee Challan 9. Legal Form
  • 21.
    MD-8 Application Documents RequiredFor Grant of Loan License to Manufacture for Sale or Distribution of Class C & Class D: S. No. Documents 1. Covering Letter 2. Constitution Details of Manufacturer, 3. Site or plant master file as specified in Appendix I of Fourth Schedule of MDR 2017. 3.1 Part – 1 Plant Layout of premise with indication of scale 3.2 Part – 2 Organization chart showing the arrangements for key personnel 3.3 Part – 3 Qualification, Experience and responsibilities of key Technical Persons 3.4 Part – 4 List of Equipment and Instruments 3.5 Part – 5 Contract Activities if any
  • 22.
    S. No. Documents 4.Quality Management System 4.1 Part – 1 Quality Management System as per Fifth Schedule of Medical devices Rules, 2017 4.2 Part – 2 Quality Manual 4.3 Part – 3 Quality Policy 4.4 Part – 4 Control of Documents 4.5 Part – 5 Control of Records 4.6 Part – 6 Management Responsibility 4.7 Part – 7 Internal Audit System 4.8 Part – 8 Preventive and Corrective Action 4.9 Part – 9 Procedure for identifying training needs and ensure that all persons are trained to adequately perform their assigned responsibilities. 4.10 Part – 10 Table the areas showing the environmental requirement for Medical Devices as per Annexure A of Fifth Schedule of Medical devices Rules, 2017. 5. Undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule of MDR 2017
  • 23.
    S. No. Documents 6.Regulatory certificates 6.1 copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within last 3 years .(if any) 6.2 copy of NOC from Department of Animal Husbandry, Ministry of Agriculture, In Case of Veterinary IVD Kits (if available) 6.3 copy of NOC from Bhabha Atomic Research Centre (BARC), Mumbai, In case Radio Immuno Assay Kits (if available) 6.4 valid copy of Quality Management System certificate (ISO:13485) certificate issued by the competent authority .(if any) 6.5 Copy of Test licence obtained for testing and generation of quality control data, if any 6.6 Self attested copy of valid Whole sale license or manufacturing license if any 7. Device Master File for In Vitro Diagnostic Medical Devices as per Appendix – III of Part III of Fourth Schedule of Medical devices Rules, 2017 7.1.1 Part – 1 Executive Summary -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.2 Part-2 Regulatory status of the similar device in India (approved or new in vitro diagnostic medical device). -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
  • 24.
    S. No. Documents 7.1.3 Part-3Description and specification, including variants and accessories of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.4 Part – 4 Essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the in vitro medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.5 Part – 5 Risk analysis and control summary - STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.6 Part – 6 Device Design and Manufacturing Information - STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.7 Part-7 Product validation and verification - STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.8 Part-8 Analytical studies, Specimen type, Analytical performance characteristics, Analytical sensitivity, Analytical Specificity, Metrological traceability of calibrator and control material values, Measuring range of assay, Definition of assay -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.9 Part – 9 Claimed Shelf life - stability study report for at least 3 lots including the protocol, acceptance criteria, testing intervals and conclusion. -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
  • 25.
    S. No. Documents 7.1.10 Part-10In use stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.11 Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.12 Part-12 Clinical Evidence -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.13 Part-13 Product Insert, Pack size, Label -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.14 Part-14 Specimen batch test report for at least consecutive 3 batches showing specification of each testing parameter -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.15 Part-15 Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
  • 26.
    S. No. Documents 7.1.16 Part-16Copy of performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of rule 83 of MDR 2017 for three batches -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.17 Part-17 Post Market Surveillance Data -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.1.18 Part-18-Others -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.1 Part – 1 Executive Summary -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.2 Part-2 Regulatory status of the similar device in India (approved or new in vitro diagnostic medical device). -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.3 Part-3 Description and specification, including variants and accessories of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.4 Part – 4 Essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the in vitro medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
  • 27.
    S. No. Documents 7.2.5 Part– 5 Risk analysis and control summary -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.6 Part – 6 Device Design and Manufacturing Information -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.7 Part-7 Product validation and verification -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.8 Part-8 Analytical studies, Specimen type, Analytical performance characteristics, Analytical sensitivity, Analytical Specificity, Metrological traceability of calibrator and control material values, Measuring range of assay, Definition of assay -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.9 Part – 9 Claimed Shelf life - stability study report for at least 3 lots including the protocol, acceptance criteria, testing intervals and conclusion. -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.10 Part-10 In use stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
  • 28.
    S. No. Documents 7.2.11 Part-11Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for Part-11 Shipping stability study report for 1 lot including the protocol, acceptance criteria, testing intervals and conclusion for -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.12 Part-12 Clinical Evidence -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.13 Part-13 Product Insert, Pack size, Label -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.14 Part-14 Specimen batch test report for at least consecutive 3 batches showing specification of each testing parameter -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.15 Part-15 Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the in vitro diagnostic medical device -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.16 Part-16 Copy of performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of rule 83 of MDR 2017 for three batches -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL.
  • 29.
    S. No. Documents 7.2.17 Part-17Post Market Surveillance Data -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 7.2.18 Part-18-Others -- STAMPING, STICKERING, OVERPRINTING ON FINISHED PRODUCT PACKINGS WITHOUT CHANGING ORIGINAL LABEL. 8. Fee Challan 9. Legal Form
  • 30.
    MD-14 Application Fees ForImport License: S. No. Subject Fees 1. Import license for Class A (other than non-sterile and non-measuring) medical devices other than in vitro diagnostic medical devices for,- (a) one site; and (b) each distinct medical device. $1000 $50 2. Import license for Class B medical device other than in vitro diagnostic medical device for,- (a) one site; and (b) each distinct medical device. $2000 $1000 3. Import license for Class A (other than non-sterile and non-measuring) or Class B in vitro diagnostic medical device for,- (a) one site; and (b) each distinct in vitro diagnostic medical device. $1000 $10 4. Import license for Class C or Class D medical device other than in vitro diagnostic medical devices for,- (a) one site; and (b) each distinct medical device. $3000 $1500
  • 31.
    S. No. SubjectFees 5. Import license for Class C or Class D in vitro diagnostic medical device for,- (a) one site; and (b) each distinct in vitro diagnostic medical device. $3000 $500 6. Manufacturing license or loan license to manufacture Class A (other than non-sterile and non-measuring) or Class B medical device for,- (a) one site; and (b) each distinct medical device. Rs. 5000 Rs. 500 7. Manufacturing license or loan license to manufacture Class C or Class D medical device for,- (a) one site; and (b) each distinct medical device. Rs. 50000 Rs. 1000 8. Manufacturing license or loan license retention fee for,- (a) one site manufacturing Class A (other than non-sterile and non-measuring) or Class B medical device; or (b) one site of manufacturing Class C or Class D medical device; or (c) each distinct medical device of Class A (other than non-sterile and non-measuring) or Class B; or (d) each distinct medical device of Class C or Class D. Rs. 5000 Rs. 50000 Rs. 500 Rs. 1000