In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945.

1. (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);

2. (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and

3. devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940;

List Of Devices

1.Grant of Certificate of Registration for a Notified Body for audit of Class A and Class B Medical Devices: A notified body accredited by National Accreditation Body( designated by Central Government) may apply in MD 1 to CLA for grant of registration certificate in MD 2.

2.Grant of Import Licence: The applicant shall make an application in MD-14 in sugam online portal for grant of import licence in MD-15 to import Medical Devices.

3.Grant of licence or loan licence to manufacture for sale or for distribution: The applicant shall make an application in MD-7 & MD-8 in sugam online portal for Grant of manufacturing Licence / Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D in MD-9 & MD-10.

4.Grant of test licence to manufacture for test, evaluation, clinical investigations, etc.:The applicant shall make an application in MD-12 in sugam online portal for licence in MD-13 to manufacture Medical Devices for purpose of clinical investigations, test, evaluation, examination, demonstration or training.

5.Grant of test licence to import for test, evaluation, clinical investigations, etc.: The applicant shall make an application in MD-16 in sugam online portal for licence in MD-17 to import Medical Devices for purpose of clinical investigations, test, evaluation, examination, demonstration or training.

6.Grant of license to Import investigational medical device by Government hospital or statutory medical institution for treatment of patient- Small quantity of investigational medical device, the import of which is not allowed, but approved in the country of origin, may be allowed to be imported by the Central Licensing Authority for treatment of a patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need, on an application made by a Medical Officer through the medical superintendent of a Government hospital or a statutory medical institution in Form MD-18

7.Permission to conduct clinical investigation of Investigational Medical Device:The applicant shall make an application in MD-22 in sugam online portal for grant of permission to conduct clinical investigation of investigational medical device in MD-23.

8.Permission to conduct clinical performance evaluation for new in vitro diagnostic medical device: The applicant shall make an application in MD-24 in sugam online portal for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device in MD-25

9.Permission to import or manufacture medical device which does not have its predicate device – The applicant shall make an application in MD 26 in sugam online portal after completion of its clinical investigation to the CLA for grant permission to import or manufacture medical device which does not have predicate medical device in Form MD-27.

10.Permission to import or manufacture new in vitro diagnostic medical device: The applicant shall make an application in MD-28 in sugam online portal for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device in MD-29.

11.Registration of Medical Device Testing Laboratory: The applicant shall make an application in MD-39 in sugam online portal for grant of registration in MD-40 to medical device (MD) testing laboratory for test or evaluation on behalf of manufacturer.

12.Preparation of Guidance and FAQ on key activities.

13.Processing of application for Issuance of Free Sale Certificate for domestic manufacturers Medical Devices.

14.Processing of application for Issuance of Market Standing Certificate and Non- Conviction for Medical Devices

15.Complaint, Not of Standard Quality (NSQ) Verification.

16.Updating the list as per the Classification of Medical Devices from time to time.

17.Post Approval Changes in respect of Medical Devices.

18.Constitution of MD experts committee.

19.Inspection of manufacturing site for compliance of QMS by CLA/SLA.

20.Capacity building activities of technical management.

21.Preparing and submitting replies of Parliament Questions/RTIs/Clarifications/NOCs/ Port office queries

22.Providing clarification to applicant on the regulatory status of products