India Releases Comprehensive Reference Manual on New Medical Device Rules

India’s Ministry of Health & Family Welfare released a 241-page draft guidance to help devicemakers better understand the country’s new device rules that came into effect in January.

Prepared by the Indian Pharmacopoeia Commission, the guidance covers regulatory requirements, quality management systems and standards and is intended to serve as a reference manual that will be updated as needed.

The guidance covers the device classification system, notified bodies and general requirements for good manufacturing practices. For Class A and Class B devices, the State Drugs Controller serves as the State Licensing Authority, while higher-risk Class C and Class D devices are regulated by the Central Licensing Authority.