India’s Latest Medical Devices Draft, 2016

The Union Health Ministry has released a draft for Medical Devices Rules under the existing Drugs and Cosmetics (D&C) Act and also a completely new rule to replace the 1940 Act. The Drugs and Cosmetics Act and Rules will likely see revision in standard related to the study of new drugs, systems and modes of drug delivery.

Medical devices other than in-vitro diagnostic (IVD) devices shall be classified on the basis of parameters specified in Part I of the First Schedule by the Central Government by notification in the Official Gazette.

Low risk (Class A)
Low moderate risk (Class B)
Moderate high risk (Class C)
High risk (Class D)

Under these Medical Devices draft rules,

Substances covered under sub-clause (i) of clause (b) of section 3 used for IVD
Substances covered under sub-clause (ii) of clause (b) of section 3 used for nature of mechanical devices
Devices specified from time to time by notification in the Official Gazette under sub-clause (iv) of clause (b) of section 3 of the (D&C) Act, 1940 (23 of 1940)

Medical devices already marketed in India

Medical devices which are already marketed in India earlier to the commencement of these rules shall continue to be marketed as before subject to the condition that the manufacturer shall provide evidence of past sale in India and apply for license within a period of 90 days from the date the device is notified under sub-clause (iv) of clause (b) of section 3 of the (D&C) Act, 1940 (23 of 1940).
The Central Government shall, by notification, specify the date from which medical device mentioned in clause (2) will be regulated in accordance with these rules.

Medical devices already notified in India

Medical device already notified under sub-clause (iv) of clause (b) of section 3 of the (D&C) Act, 1940 and marketed in India earlier to the commencement of these rules shall continue to be marketed as before till the expiry of 18 months from the start of these rules.
For the purposes of these rules, the IVD medical devices which are already marketed in India and ruled under sub-clause (i) of clause (b) of section 3 of the (D&C), 1940 shall be considered to be medical devices and will also continue to be marketed as before till the expiry of 18 months from the commencement of these rules.

The rules divide licencing and enforcement powers between the Central and states.

Central Licensing authority Powers

The Drugs Controller General of India (DCGI) shall be the Central Licensing Authority and shall be the competent authority for execution of these rules in matters relating to import, manufacture of Class C and Class D medical devices, clinical study and clinical performance evaluation of medical devices and other related functions, provided that where any manufacturer plan to manufacture Class C or Class D medical device along with Class A or Class B medical device.
The Central Licensing Authority has power for execution of these rules and no separate licence from the State Licensing Authorities (SLA) shall be required in respect of devices of Class A or Class B.

State Licensing Authority Powers

State Licensing Authority (SLA) is the competent authority for execution of these rules in matters relating to production of Class A or Class B medical devices, stock, exhibit or offer for medical devices sale and other related functions, Provided that where any person plans to manufacture predicate medical devices, before applying to the State Licensing Authority earlier approval from the Central Licensing Authority is necessary.