India postpones the implementation of licensing requirements for higher-risk medical devices.

In 2020, India outlined plans to revamp the regulatory framework for medical devices adopting a phased approach. While manufacturers of low and low-moderate risk devices were required to comply with the new rules and obtain a license in 2022, the enforcement of these requirements for higher-risk Class C and D products was deferred until 1st October 2023.

Multiple stakeholders and representatives reached out to the agency expressing their interest in ensuring business continuity. India’s Central Drugs Standard Control Organization (CDSCO) has decided to postpone the implementation of new regulations for Class C and D medical devices in response to feedback.

Additionally, CDSCO announced that manufacturers who have not yet obtained the necessary licenses for Class C and D products are permitted to proceed with the sale of their medical devices.

The CDSCO agreed to give more time to companies that have submitted an application but have yet to receive a license. Allowing manufacturer or importer who filed application by the end of September 2023, to continue to sell the medical device for up to six months. The regulatory flexibility will end when CDSCO rules on the application or at the end of six months.