Forms: All types of Medical Devices

Applications Forms: All types of Medical Devices under Medical Devices Rules 2017

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SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
Rakesh Dahiya

Last Updated on January 21, 2024 by The Health Master

Forms of All types of Medical Devices under Medical Devices Rules 2017

Law Books Act
Law Books Act

As per Medical Devices Rules 2017 we have provided all 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-1

Form MD 2: Certificate of Registration for a Notified Body under the Medical Devices Rules, 2017

Form-MD-2

Form MD 3: Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device

Form-MD-3

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-4

Form MD 5: Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device

Form-MD-5

Form MD 6: Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device

Form-MD-6

Form MD 7: Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D

Form-MD-7

Form MD 8: Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D

Form-MD-8

Form MD 9: Licence to Manufacture for Sale or for Distribution of Class C or Class D

Form-MD-9

Form MD 10: Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device

Form-MD-10

Form MD 11: Form in which the Audit or Inspection Book shall be maintained

Form-MD-11

Form MD 12: Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training

Form-MD-12

Form MD 13: Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training

Form-MD-13

Form MD 14: Application for issue of import licence to import medical device

Form-MD-14

Form MD 15: Licence to Import Medical Device

Form-MD-15

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-16

Form MD 17: Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training

Form-MD-17

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-18

Form MD 19: Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients

Form-MD-19

Form MD 20: Application for permission to import small quantity of medical devices for personal use

Form-MD-20

Form MD 21: Permission to import of small quantity of medical devices for personal use
Form-MD-21

Form MD 22: Application for Grant of permission to conduct clinical investigation of an investigational medical device

Form-MD-22

Form MD 23: Permission to conduct Clinical Investigation

Form-MD-23

Form MD 24: Application for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device

Form-MD-24

Form MD 25: Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device

Form-MD-25

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-26

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-27

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-28

Form MD 29: Permission to Import or Manufacture New In Vitro Diagnostic Medical Device

Form-MD-29

Form MD 30: Memorandum to the Central Medical Device Testing Laboratory

Form-MD-30

Form MD 31: Certificate of test or evaluation by the Central Medical Device Testing Laboratory

Form-MD-31

Form MD 32: Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer

Form-MD-32

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-33

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-34

Form 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)

Form-MD-35

Form MD 36: Intimation of Person from Whom Sample is taken

Form-MD-36

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-37

Form MD 38: Memorandum to Medical Device Testing Officer

Form-MD-38

Form 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

Form-MD-39

Form MD 40: Certificate of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer

Form-MD-40

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

Form-MD-1-to-Form-MD-43

Forms: Drugs

Forms: Cosmetics

Forms: Medical Devices

Forms: Clinical Trial

Schedules: Drugs

Schedules: Cosmetics

Schedules: Medical Devices

Schedules: Clinical Trials

Licenses-fee-structure-for-all-licenses


Compiled by:
Rakesh Dahiya
SDCO cum Licensing Authority, FDA Haryana

Licensing procedure for Medical devices

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