Apr 18, 2016

The Indian Ministry of Health and Family Welfare has issued draft rules that establish registration and quality system requirements for medical devices and IVDs distinct from pharmaceutical products.

Although the new rules pertain only to medical device manufacturers based in India, they are significant for all domestic and foreign participants in the country’s medical device market by showing that the Indian government now recognizes and distinguishes medical devices as a separate industry from pharmaceuticals. This move also suggests that the government may act on implementing other efforts and initiatives to develop a more formalized registration process in the country.

Previously, both pharmaceuticals and medical devices were grouped together under Schedule M of India’s Drugs and Cosmetics Rules; now, the government is proposing moving medical devices and IVDs to a separate structure, Schedule M-III.

As drafted, Schedule M-III contains its own set of requirements for quality management systems pertaining to all notified medical devices and IVDs, plus appendices covering Device Master Files and Site Master Files.

The Indian government has now opened a 45-day comment period for the draft rules, after which any comments received will be considered. Emergo consultants in India will continue monitoring these developments and report on any impacts foreign medical device registrants should expect.


  • Stewart Eisenhart