India Sets Compliance Timing for New Device Regulations

India’s Ministry of Health and Family Welfare has established a transition timeline for its new medical device rules that go into force on April 1.

The government is allowing an 18-month transition period for the new regulations that will treat medical devices sold in India as drugs. Once the transition period ends, devices will need to be registered with the central licensing authority through an online portal established by the Central Drugs Standard Control Organization.

Higher-risk devices classified as Class C and D will have 42 months to comply with the new regulations, which include quality and pricing oversight. Devices that are low and moderate risk (Class A and B) will have 30 months to comply.