Forms: Medical Devices

Applications Forms: Medical Devices Rules 2017

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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-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 a 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 a small quantity of medical devices for personal use

Form-MD-20

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

Form-MD-21

Form MD 22: Application for Grant of permission to conduct a 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 a clinical performance evaluation of new in vitro diagnostic medical device

Form-MD-24

Form MD 25: Permission to conduct a 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 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-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 carrying out Test or Evaluation of a medical device on behalf of the manufacturer

Form-MD-39

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-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-41

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-42

Form MD 43: Form in which the Inspection Book shall be maintained

Form-MD-43

Form MD 1 to MD 43: Download all forms at once, click the below link

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

Also download other forms

Forms: Drugs

Forms: Cosmetics

Forms: Medical Devices

Forms: Clinical Trial

Also download Shedules

Schedules: Drugs

Schedules: Cosmetics

Schedules: Medical Devices

Schedules: Clinical Trials

Also download fee structure for all licenses

Licenses-fee-structure-for-all-licenses

For more details on licensing process of Medical devices, click here

For notifications of Medical Devices, click here
https://thehealthmaster.com/application-forms/forms-medical-devices/