India – India Commits to Phased Overhaul of Medical Device Regulations

The Indian government has set out the timeline for moving to a new regulatory system for medical devices. Officials intend to institute a law that will increase oversight of all medical devices on 1 April but will defer enforcing the new requirements for upward of 18 months.

Last year, the Indian government published draft legislation that would see all medical devices sold in India treated as drugs for regulatory purposes. Historically, India has only subjected a fraction of the devices sold in the country to the more stringent drug regulations. The government detailed plans to expand the use of the regulations in 2018, starting initially with nebulizers, blood pressure monitors, digital thermometers and glucometers, and has since moved to bring more devices under the rules.