Last Updated on January 21, 2024 by The Health Master
Forms: for Medical Devices
Applications Forms: Medical Devices Rules 2017
As per Medical Devices Rules 2017 we have provided Application Forms relevant to the above said topic, Click below links for more information:
Form MD 1: Application for grant of Certificate of Registration of a Notified Body
Form MD 2: Certificate of Registration for a Notified Body under the Medical Devices Rules, 2017
Form MD 3: Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device
Form MD 4: Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device
Form MD 5: Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device.
Form MD 6: Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device
Form MD 7: Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D
Form MD 8: Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D
Form MD 9: Licence to Manufacture for Sale or for Distribution of Class C or Class D
Form MD 10: Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device
Form MD 11: Form in which the Audit or Inspection Book shall be maintained
Form MD 12: Application for licence to manufacture a medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training
Form MD 13: Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
Form MD 14: Application for issue of import licence to import medical device
Form MD 15: Licence to Import Medical Device
Form MD 16: Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
Form MD 17: Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
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
Form MD 19: Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients
Form MD 20: Application for permission to import a small quantity of medical devices for personal use
Form MD 21: Permission to the import of small quantity of medical devices for personal use
Form MD 22: Application for Grant of permission to conduct a clinical investigation of an investigational medical device
Form MD 23: Permission to conduct Clinical Investigation
Form MD 24: Application for grant of permission to conduct a clinical performance evaluation of new in vitro diagnostic medical device
Form MD 25: Permission to conduct a clinical performance evaluation of new in vitro diagnostic medical device
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
Form MD 27: Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device
Form MD 28: Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device
Form MD 29: Permission to Import or Manufacture New In Vitro Diagnostic Medical Device
Form MD 30: Memorandum to the Central Medical Device Testing Laboratory
Form MD 31: Certificate of test or evaluation by the Central Medical Device Testing Laboratory
Form MD 32: Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer
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)
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
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)
Form MD 36: Intimation of Person from Whom Sample is taken
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
Form MD 38: Memorandum to Medical Device Testing Officer
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
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
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
Form MD 42: Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device
Form MD 43: Form in which the Inspection Book shall be maintained
Form MD 1 to MD 43: Download all forms at once, click the below link
Licenses-fee-structure-for-all-licenses
For more details on licensing process of Medical devices, click here
For notifications of Medical Devices, click here
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