CDSCO public Form MD-14 checklist — MD — Public Form MD-14 medical-device import checklist — fresh, endorsement and retention
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Contents
CHECKLIST
Form Name: Form MD-14
Category: MD
FRESH
Section no. Checklist Name Is Mandatory
1.0 Covering Letter Yes
2.0 Fee Challan Yes
3.0 Application (Form MD-14) Yes
Power of Attorney along with undertaking
4.0 from the authorized agent as per Part I of Yes
Fourth Schedule of MDR, 2017 (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)
Copy of Whole Sale licence / Manufacturing
5.0 licence / Registration Certificate in Form MD- Yes
42 of the Authorized agent
6.0 Constitution details of the authorized agent Yes
7.0 Regulatory Certificate No
Copy of Free Sale Certificate/Marketing
7.1 Authorization of the product issued by the Yes
National Regulatory Authority of country of
origin (if any) (duly notarized)
Copy of Free Sale Certificate Marketing
7.2 Authorization of the product isued from Yes
National Regulatory Authority of any of the
following countries viz USA, UK, EU, Canada,
Japan or Australia (duly notarized)
Copy of overseas manufacturing site /
7.3 establishment / plant registration, by Yes
whatever name called, in the country of
origin issued by the competent authority
(duly notarized)
Copy of latest inspection or audit report
7.4 carried out by the Competent Authority Yes
within last 3 years, if any.
Quality Certificate in respect of the actual
8.0 No
manufacturing site, as applicable
Copy of Certificate supporting Quality
8.1 Yes
Management System (duly notarized)
CDSCO public Form MD-14 checklist — MD — official PDF page 1
Copy of Full Quality Assurance Certificate/ CE
8.2 type examination Certificate/ CE product Yes
quality asurance certificate, CE design
Certificate, etc as applicable (duly notarized)
Declaration of conformity issued by the
8.3 Yes
manufacturer
Plant Master file from the Manufacturer as
9.0 per Appendix I of Fourth Schedule of Medical Yes
Devices Rules, 2017
Device Master file from the Manufacturer as
10.0 per Appendix II of Fourth Schedule of No
Medical Devices Rules, 2017
10.1 Executive Summary Yes
10.2 Descriptive information of the device Yes
10.3 Justification for the Medical Device Grouping Yes
Product Specification, including variants,
10.4 Yes
accessories, etc
Substantial equivalence with reference to the
10.5 predicate device or previous generations of Yes
the device
Labelling information (Labels, Instruction for
10.6 Yes
Use, etc)
Device Design and Manufacturing
10.7 Yes
Information
Essential Principles checklist for
10.8 demonstrating conformity to the Safety and Yes
Performance of the Medical Device
10.9 Risk analysis and control summary Yes
Verification and validation of the medical
10.10 Yes
device
Biocompatibility validation data (if
10.11 Yes
applicable)
Medicinal substances data (if device contains
10.12 Yes
Drug)
10.13 Biological Safety (TSE/BSE), if applicable Yes
10.14 Sterilization Validation data (if applicable) Yes
Software verification and validation (if
10.15 Yes
software used)
10.16 Animal studies – Preclinical data (if any) Yes
Stability study data (Real-time and
10.17 Accelerated conditions) for the claimed shelf Yes
life (if applicable)
10.18 Clinical evidence (if any) Yes
Post Marketing Surveillance data (Vigilance
10.19 Yes
reporting)
CDSCO public Form MD-14 checklist — MD — official PDF page 2
Batch Release Certificates or Certificate of
10.20 Analysis for minimum 3 consecutive batches/ Yes
Software version release certificate
11.0 Any other additional documents Yes
Copy of Permission in Form MD-27 (incase of
12.0 Yes
Investigational Medical Device )
ENDORSEMENT
Section no. Checklist Name Is Mandatory
1.0 Covering letter Yes
2.0 Application (Form MD-14) Yes
3.0 Fee Challan Yes
Power of Attorney along with undertaking
4.0 from the authorized agent as per Part I of Yes
Fourth Schedule of MDR, 2017 (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)
Copy of Import License obtained for which
5.0 Yes
the endorsement is applied
6.0 Regulatory Certificate Yes
Copy of Free Sale Certificate/Marketing
6.1 Authorization of the product issued by the Yes
National Regulatory Authority of country of
origin (if any) (duly notarized)
Copy of Free Sale Certificate Marketing
6.2 Authorization of the product isued from Yes
National Regulatory Authority of any of the
following countries viz USA, UK, EU, Canada,
Japan or Australia (duly notarized)
Quality Certificate in respect of the actual
7.0 manufacturing site, as applicable (duly Yes
notarized)
Copy of Certificate supporting Quality
7.1 Yes
Management System
Copy of Full Quality Assurance Certificate/
7.2 CE type examination Certificate/ CE product Yes
quality asurance certificate, CE design
Certificate, etc as applicable
Declaration of conformity issued by the
7.3 Yes
manufacturer
CDSCO public Form MD-14 checklist — MD — official PDF page 3
Undertaking from the overseas
8.0 manufacturer stating that there is no major Yes
change(s) in the existing Plant Master File
(PMF). Otherwise, information as per
Appendix I of Fourth Schedule of Medical
Devices Rules, 2017 needs to be submitted
Device Master file from the Manufacturer as
9.0 per Appendix II of Fourth Schedule of Yes
Medical Devices Rules, 2017
9.1 Executive Summary Yes
9.2 Descriptive information of the device Yes
9.3 Justification for the Medical Device Grouping Yes
Product Specification, including variants,
9.4 Yes
accessories, etc.
Substantial equivalence with reference to
9.5 the predicate device or previous generations Yes
of the device
Labelling information (Labels, Instruction for
9.6 Yes
Use, etc)
Device Design and Manufacturing
9.7 Yes
Information
Essential Principles checklist for
9.8 demonstrating conformity to the Safety and Yes
Performance of the Medical Device
9.9 Risk analysis and control summary Yes
Verification and validation of the medical
9.10 Yes
device
Biocompatibility validation data (if
9.11 Yes
applicable)
Medicinal substances data (if device contains
9.12 Yes
Drug)
9.13 Biological Safety (TSE/BSE), if applicable Yes
9.14 Sterilization Validation data (if applicable) Yes
Software verification and validation (if
9.15 Yes
software used)
9.16 Animal studies – Preclinical data (if any) Yes
Stability study data (Real-time and
9.17 Accelerated conditions) for the claimed shelf Yes
life (if applicable)
9.18 Clinical evidence (if any) Yes
Post Marketing Surveillance data (Vigilance
9.19 Yes
reporting)
CDSCO public Form MD-14 checklist — MD — official PDF page 4
Batch Release Certificates or Certificate of
9.20 Analysis for minimum 3 consecutive Yes
batches/ Software version release certificate.
10.0 Any other additional documents Yes
Copy of Permission in Form MD-27 (incase of
11.0 Yes
Investigational Medical Device )
RETENTION
Section no. Checklist Name Is Mandatory
An undertaking from the manufacturer
1.0 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
2.0 reporting) during last 5 yrs. (details of No
complaints, recall from any country (if any),
CAPA taken, etc), duly authenticated by the
manufacturer or authorized agent.
Duly notarized valid Free Sale
3.0 Certificate/Marketing Authorization of the No
product issued by the National Regulatory
Authority of country of origin (if any)
Duly notarized valid Free Sale Certificate
4.0 Marketing Authorization of the product Yes
issued from National Regulatory Authority of
any of the following countries viz USA, UK,
EU, Canada, Japan or Australia)
Copy of Certificate supporting Quality
5.0 Management System, Full Quality Assurance Yes
Certificate/ CE type examination Certificate/
CE product quality assurance certificate, CE
design Certificate, DOC etc.,
POA along with undertaking from the
6.0 authorized agent as per Part I of Fourth Yes
Schedule of MDR, 2017 (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)
shall be submitted.
7.0 Duly Signed Retention Application Yes
8.0 Fee Challan Yes
CDSCO public Form MD-14 checklist — MD — official PDF page 5
