Indian regulators separate medical device and pharmaceutical rules

 19-Apr-16, MassDevice 

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.

Image: Business Today

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.

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