Indian Medical Device rules 2017- Forms
• MD-1 Application for grant of Certificate of Registration of a Notified Body
• MD-2 Certificate of Registration for a Notified Body under the Medical Devices Rules, 2017
• MD-3 Application for Grant of License to Manufacture for Sale and Distribution of Class A/ Class B
• MD-4 Application for Grant of Loan License to Manufacture for Sale or for Distribution of Class A /Class B
• MD-5 License to Manufacture for Sale or for Distribution of Class A/Class B.
• MD-6 Loan License to Manufacture for Sale or for Distribution of Class A/Class B
• MD-7 Application for Grant of License to Manufacture for Sale or for Distribution of Class C/Class D
• MD-8 Application for Grant of Loan License to Manufacture for Sale or for Distribution of Class C/Class D
• MD-9 License to Manufacture for Sale or for Distribution of Class C/Class D
• MD-10 Loan License to Manufacture for Sale or for Distribution of Class C/Class D
• MD-11 Form in which the Audit or Inspection Book shall be maintained.
• MD-12 Application for license to manufacture medical device for purpose of clinical investigations,test,
evaluation, examination, demonstration or training
• MD-13 License to Manufacture Devices for the Purposes of Clinical Investigations/Test/Evaluation/Training
• MD-14 Application for issue of import license to import medical device
• MD- 15 License to Import Medical Device
• MD-16 Application for License to Import Devices for the Purposes of Clinical
Investigations/Test/Evaluation/Training
• MD-17 License to Import Devices for the Purposes of Clinical Investigations or
Test/Evaluation/Demonstration/Training
• MD-18 Application for license to import investigational medical devices for the purposes by a government
hospital or statutory medical institution for the treatment of patients
• MD-19 License to import investigational medical device by a government hospital or statutory medical
institution for the treatment of patients
• MD-20 Application for permission to import small quantity of medical devices for personal use
• MD-21 Permission to import of small quantity of medical devices for personal use
• MD-22 Application for Grant of permission to conduct clinical investigation of an investigational device
• MD-23 Permission to conduct Clinical Investigation
• MD-24 Application for grant of permission to conduct clinical performance evaluation of new in vitro
diagnostic medical device
• MD-25 Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device
• MD-26 Application for grant of permission to import / manufacture for sale or for distribution of medical
device which does not have predicate medical device
• MD-27 Permission to import/manufacture/distribution of device which does not have predicate device
• MD- 28 Application for grant of permission to Import or Manufacture for sale or for distribution of new in
vitro diagnostic medical device
• MD-29 Permission to Import or Manufacture New In Vitro Diagnostic Medical Device
• MD-30 Memorandum to the Central Medical Device Testing Laboratory
• MD- 31 Certificate of test or evaluation by the Central Medical Device Testing Laboratory
• MD-32 Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer
• MD-33 Application from a purchaser for test or evaluation of a Medical Device under section 26 of the Drugs
and Cosmetics Act, 1940 (23 of 1940)
• MD-34 Order under clause (c) of sub-section (1) of section of the Drugs and Cosmetics Act, 1940, (23 of
1940) requiring a person not to dispose of stock in his possession
• MD-35 Receipt for stock of medical devices for record, register, document or material object seized under
clause (c) or clause (cc) of sub-section (1) of Section 22 of the Drugs and Cosmetics Act (23 of 1940)
• MD- 36 Intimation of Person from Whom Sample is taken
• MD-37 Receipt for Sample of medical device(s) taken where fair price tendered thereof under sub-section (1)
of Section 23 of the Drugs and Cosmetics Act, 1940 is refused
• MD-38 Memorandum to Medical Device Testing Officer
• MD-39 Application for grant of registration to Medical Device Testing Laboratory for carry out Test or
Evaluation of a medical device on behalf of manufacturer
• MD-40 Certificate of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a
medical device on behalf of manufacturer
