CHECKLIST

Form Name: Form MD-3

Category: IVD
FRESH

Section no. Checklist Name Is Mandatory

1.0 Covering Letter, Yes

2.0 Constitution Details of Manufacturer, Yes

Site or plant master file as specified in

3.0 No
Appendix I of Fourth Schedule of MDR 2017.,

3.1 Part 1, Yes

3.2 Part 2, No

3.3 Part 3, No

3.4 Part 4, No

3.5 Part 5, No

Device master file as specified in Appendix

4.0 No
III of Fourth Schedule of MDR 2017,

4.1 Part 1, Yes

4.2 Part 2, No

4.3 Part 3, No

4.4 Part 4, No

4.5 Part 5, No

Essential principles checklist for

5.0 demonstrating conformity to the essential Yes
principles of safety and performance of the
in vitro medical device,
 Undertaking signed by the manufacturer
6.0 stating that the manufacturing site is in Yes
compliance with the provisions of the Fifth
Schedule of MDR 2017,

7.0 Labelling and Pack Size, Yes

8.0 Regulatory Certificates, No

copy of latest inspection or audit report

8.1 carried out by Notified bodies or National No
Regulatory Authority or Competent
Authority within last 3 years, if any.,
valid copy of Quality Management System
8.2 certificate (ISO:13485) certificate issued by No
the competent authority .(if any),
copy of NOC from Department of Animal
8.3 Husbandry, Ministry of Agriculture, In Case No
of Veterinary IVD Kits (if available),
copy of NOC from Bhabha Atomic Research
8.4 Centre (BARC), Mumbai, In case Radio No
Immuno Assay Kits (if available),

Copy of Test licence obtained for testing and

8.5 No
generation of quality control data, if any,

Self attested copy of valid Whole sale licence

8.6 No
or manufacturing licence if any,
Specific evaluation report, if done by any
9.0 laboratory in India, showing the sensitivity No
and specificity of the in vitro diagnostic
medical device ( For class B medical devices)
(if available),
Specimen batch test report for at least
10.0 consecutive 3 batches showing specification No
of each testing parameter( For class B
medical devices),
Copy of performance evaluation report
11.0 issued by the central medical device testing No
laboratory or medical device testing
laboratory registered under sub-rule (3) of
rule 83 of MDR 2017 for three batches ( For
class B medical devices) ,
A summary of analytical technology, relevant
12.0 analytes and test procedure( For class A No
medical devices),
Working principle and use of a novel
13.0 technology ( For class A medical devices)(if No
any),

14.0 Stability( For class B medical devices), No

Claimed Shelf life - stability study report for

14.1 at least 3 lots including the protocol, No
acceptance criteria, testing intervals and
conclusion.,
In use stability study report for 1 lot
14.2 including the protocol, acceptance criteria, No
testing intervals and conclusion,
Shipping stability study report for 1 lot
14.3 including the protocol, acceptance criteria, No
simulated conditions, conclusion and
recommended shipping conditions,
 15.0 Product Insert ( For class B medical devices), No

16.0 Fees Challan Yes

17.0 Legal Form Yes

ENDORSEMENT

Mandatory or
Section no. Checklist Name
NO RECORD FOUND not

1.0 Covering Letter, Yes

2.0 Constitution Details of Manufacturer, Yes

Device master file as specified in Appendix

4.0 No
III of Fourth Schedule of MDR 2017,

4.1 Part 1, Yes

4.2 Part 2, No

4.3 Part 3, No

4.4 Part 4, No

4.5 Part 5, No

Essential principles checklist for

5.0 demonstrating conformity to the essential Yes
principles of safety and performance of the
in vitro medical device,
Undertaking signed by the manufacturer
6.0 stating that the manufacturing site is in Yes
compliance with the provisions of the Fifth
Schedule of MDR 2017,

7.0 Labelling and Pack Size, Yes

8.0 Regulatory Certificates, No

copy of latest inspection or audit report

8.1 carried out by Notified bodies or National No
Regulatory Authority or Competent Authority
within last 3 years, if any.,
valid copy of Quality Management System
8.2 certificate (ISO:13485) certificate issued by No
the competent authority .(if any),
copy of NOC from Department of Animal
8.3 Husbandry, Ministry of Agriculture, In Case of No
Veterinary IVD Kits (if available),
copy of NOC from Bhabha Atomic Research
8.4 Centre (BARC), Mumbai, In case Radio No
Immuno Assay Kits (if available),
Copy of Test licence obtained for testing and
8.5 No
generation of quality control data, if any,
 Self attested copy of valid Whole sale licence
8.6 No
or manufacturing licence if any,
Specific evaluation report, if done by any
9.0 laboratory in India, showing the sensitivity No
and specificity of the in vitro diagnostic
medical device ( For class B medical devices)
(if available),
Specimen batch test report for at least
10.0 consecutive 3 batches showing specification No
of each testing parameter( For class B
medical devices),
Copy of performance evaluation report
11.0 issued by the central medical device testing No
laboratory or medical device testing
laboratory registered under sub-rule (3) of
rule 83 of MDR 2017 for three batches ( For
class B medical devices) ,
A summary of analytical technology, relevant
12.0 analytes and test procedure( For class A No
medical devices),
Working principle and use of a novel
13.0 technology ( For class A medical devices)(if No
any),

14.0 Stability( For class B medical devices), No

Claimed Shelf life - stability study report for

14.1 at least 3 lots including the protocol, No
acceptance criteria, testing intervals and
conclusion.,
In use stability study report for 1 lot
14.2 including the protocol, acceptance criteria, No
testing intervals and conclusion,
Shipping stability study report for 1 lot
14.3 including the protocol, acceptance criteria, No
simulated conditions, conclusion and
recommended shipping conditions,

15.0 Product Insert ( For class B medical devices), No

16.0 Fees Challan Yes

17.0 Legal Form Yes

RETENTION

Mandatory or
Section no. Checklist Name
not

1.0 Covering letter with purpose of application Yes

Undertaking duly signed and stamped with

2.0 designation from manufacturer that there is Yes
no change in the Constitution of the Firm.
Duly signed Undertaking and stamped with
3.0 designation from manufacturer stating that Yes
there is no change in Plant Master File &
Device Master File.
Qualification, experience and responsibilities
4.0 Yes
of current competent Technical staff.
Post Marketing Surveillance data (Details of
5.0 Yes
Sales, complaints,Recall, CAPA if any).
6.0 Any other additional documents. Yes

Copy of existing manufacturing license (MD-

7.0 5/MD-6/MD-9/MD-10) for which retention is Yes
applied.

8.0 Post Approval Change Applications (If Any) No

Retention Fee Challan along with late fees (if

9.0 Yes
any).

10.0 Duly Signed Retention Form Yes