To reinforce the regulations on Medical Devices in India, the Central Drugs Standard Control Organization (CDSCO) published two amendments to the 2017 medical device regulation. Both amendments will enter into force from April 1, 2020.

CDSCO publishes two amendments of 2017 Medical Device Rule
CDSCO publishes two amendments of 2017 Medical Device Rule

Concerning the first amendment, CDSCO widened the definition of “Medical Device”. The new definition of medical device is more aligned with the Global Harmonization Task Force (GHTF) approach, increasing, in this way, the area of the products that will require the registration.

In the second amendment, instead, CDSCO added the “Chapter: IIIA – Medical Devices Registration” at the current 2017 Medical Device Rule, to regulate some Medical Devices that were not previously included.

A new registration procedure is required, where the Manufacturers can provide the documentation and the certifications required for the regulatory review by using an online portal.

CDSCO provides to Manufacturers a period of assistance of 18 months from the implementation date of the chapter IIIA required in the second amendment. After the implementation date the change will become mandatory for all the Manufacturers of Medical Devices. The regulatory requirements for modifications are applicable to Medical Devices in the following timings:  

  • Class A and Class B – 30 months after the implementation date;
  • Class C and Class D – 42 months after the implementation date.

For further information on the registration of a medical device in India see the relevant page in the section COUNTRIES on our website.