India Considers Streamlining Import Regulations for EU-Approved Medical Devices

India is evaluating a proposal to amend Rule 63(1) of the Medical Devices Rules, 2017, to include the European Union (EU) in the list of exempted regulatory bodies for medical device imports. This potential change, set to be discussed at the upcoming Drugs Technical Advisory Board (DTAB) meeting, would align India’s import regulations with existing exemptions for devices approved by authorities from the US, UK, Australia, Canada, and Japan.

The proposal, which has been under review since 2018 following discussions with the EU on trade regulations, was first submitted to the Health Ministry in 2021. It was subsequently referred back to the Central Drugs Standard Control Organisation (CDSCO) for further evaluation. Rajiv Nath from the Association of Indian Medical Devices Industry suggests negotiating mutual recognition agreements with the EU to ensure reciprocal benefits for Indian manufacturers.