Medical Device Forms as per MDR 2017

Download Form MD 1: Application for grant of Certificate of Registration of a Notified Body
Download Form MD 2: Certificate of Registration for a Notified Body under the Medical Devices Rules, 2017
Download Form MD 3: Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device
Download Form MD 4: Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device
Download Form MD 5: Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device.
Download Form MD 6: Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device
Download Form MD 7: Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D
Download Form MD 8: Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D
Download Form MD 9: Licence to Manufacture for Sale or for Distribution of Class C or Class D
Download Form MD 10: Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device
Download Form MD 11: Form in which the Audit or Inspection Book shall be maintained
Download Form MD 12: Application for licence to manufacture a medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training
Download Form MD 13: Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
Download Form MD 14: Application for issue of import licence to import medical device
Download Form MD 15: Licence to Import Medical Device
Download Form MD 16: Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
Download Form MD 17: Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
Download Form MD 18: Application for licence to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients
Download Form MD 19: Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients
Download Form MD 20: Application for permission to import a small quantity of medical devices for personal use
Download Form MD 21: Permission to the import of small quantity of medical devices for personal use
Download Form MD 22: Application for Grant of permission to conduct a clinical investigation of an investigational medical device
Download Form MD 23: Permission to conduct Clinical Investigation
Download Form MD 24: Application for grant of permission to conduct a clinical performance evaluation of new in vitro diagnostic medical device
Download Form MD 25: Permission to conduct a clinical performance evaluation of new in vitro diagnostic medical device
Download Form 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
Download Form MD 27: Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device
Download Form MD 28: Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device
Download Form MD 29: Permission to Import or Manufacture New In Vitro Diagnostic Medical Device
Download Form MD 30: Memorandum to the Central Medical Device Testing Laboratory
Download Form MD 31: Certificate of test or evaluation by the Central Medical Device Testing Laboratory
Download Form MD 32: Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer
Download Form 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)
Download Form 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
Download Form MD 35: Receipt for stock of medical devices for the 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)
Download Form MD 36: Intimation of Person from Whom Sample is taken
Download Form 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
Download Form MD 38: Memorandum to Medical Device Testing Officer
Download Form MD 39: Application for grant of registration to Medical Device Testing Laboratory for carrying out Test or Evaluation of a medical device on behalf of the manufacturer
Download Form MD 40: Certificate of registration to Medical Device Testing Laboratory for carrying out Test or Evaluation of a medical device on behalf of the manufacturer
Download Form MD 41: Application for grant of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device
Download Form MD 42: Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device
Download Form MD 43: Form in which the Inspection Book shall be maintained