India Proposal Would Set Distinct Standards for Medical Devices

The Drugs Controller General of India proposed rules that would for the first time set separate standards for devices.

The Indian regulator announced in July that it would abandon a proposed law that would have amended parts of India’s Drugs and Cosmetic Act of 1940, and instead develop a separate device regulation.

In the draft document, the regulator proposed third-party certification bodies, similar to those in the EU, as well as a four-tiered risk-based classification system for devices. — Tamra Sami