Regulations of Medical Devices in India

Medical Devices in India are regulated as drugs by the Central Drugs Standards Control Organization (CDSCO) as per the provisions of Medical device rules 2017 issued by the Government under the Drugs and Cosmetics Act, 1940 (“D&C Act”). Only the devices notified by the Government are regulated and falls under the provisions of regulations as per MDR17. In tune with global practice, the 2017 Rules have introduced a risk based classification system for the regulation of medical devices including Low risk (Class A), Low Moderate (Class B) Moderate High (Class C) and High-Risk devices classified as (Class D).

India’s medical device market is expected to grow over the next several years due to increased health awareness, a growing middle class, and government health initiatives. Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare.

As of September 30, 2022, all Class A and Class B medical devices are under mandatory Certification.

Class C and D will be under the regulations from September 30 2023.