The Indian medical device sector is worth approximately USD 5.5 Billion and is growing at 15% CAGR. The medical device market is dominated by imported products, which comprise of around 75% of total sales.

There are few key factors about operating in India that every serious player should be aware of. Foreign Direct Investment in medical device manufacturing sector is now possible without any prior approval. The Indian legal regime is robust and promotes innovation and commerce. Being a signatory to the TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights), India todays boast of strong patent, trademark and copyright protection within its territory.


The approximate USD 5.5 Billion worth Indian medical device sector is Asia’s fourth largest market, and presents an exciting business landscape and opportunities for both multi-national and domestic players. Until the early 1990s, the medical device sector was significantly dominated by domestic players.  But after India opened up its markets in 1991, tables have turned. The technological advancement and expertise that the global market leaders offered has proved to be an advantage.

medical-device-industryThe regulatory framework in India applicable to medical devices borrows heavily from the regulatory framework applicable to drugs. At present, only 15 types of medical devices are regulated (unfortunately, as “drugs”). The rest are unregulated. After many efforts of various stake holders, the government has notified the Medical Device Rules, 2017, which are to come into effect from the 1st of January, 2018 unless a different date is notified.

The multi nationals looking to invest in the Indian medical device sector must strategize their entry on the basis of certain key factors which will influence profitability of the investment.

For further details contact V. Sundaram – Trade Officer, Bangalore. also at 080-49406517

Excerpts from Nishith Desai Associates