Step by Step: Registration Process of Medical Devices in India
India belongs to one of the top 20 medical device markets in the world. As per various reports, the medical device market in India is expected to reach a valuation of USD 65 billion in the year 2024. Also, favorable Government policies like 100% FDI and support for R&D create profitable opportunities for foreign businesses in this sector.However, earlier manufacturers of medical devices were free to sell their products in the Indian market without any stringent regulation process. But since 2006, all medical devices imported from overseas must comply with a mandatory process of medical device registration in India regulated by the CDSCO.
Given below is a detailed overview of the various classes of medical devices and their registration process in India.