India Medical Device Consulting

The Indian medical device market is valued at $3 billion. It is the fourth largest medical device market in Asia, after Japan, China and South Korea. With improving access to healthcare services and a growing middle-income population, demand for medical devices in India is expected to grow 15% over the next five years. PBM’s India medical device consultants have worked on numerous consulting projects. We have helped international companies to market new medical devices, do product registration, find local distributors and establish local manufacturing facilities in India.

Currently, India’s expenditures on medical devices are low, at just $2.50 per capita. This is much lower than in China, at $10 per capita. However, improvements in private healthcare services towards more sophisticated medical treatments will boost the need for quality medical devices in India. More than 75% of India’s healthcare delivery is provided by private medical institutions.

There are about 120 significant local Indian medical device companies in the country. 25 of these are large local companies. Generally, local Indian medical device manufacturers make low-cost products with minimal research and development (R&D). However, there are some medium quality devices which are FDA/CE approved. Key medical devices manufactured in India include syringes, needles, urine bags, gloves, oxygen supply tubings and stents. Nevertheless, close to 80% of India’s medical devices are still imported. International companies who are interested in expanding their medical device business into India can turn to PBM’s medical device consultants for assistance.

Despite India’s large market potential for medical devices, there are no comprehensive guidelines to regulate their product standards in the country. Instead, certain medical devices in India are classified as drugs under India’s Drugs & Cosmetics Act 1940 (DCA). These include cardiac stents, drug-eluting stents, catheters, intraocular lenses, bone cements, heart valves, and scalp vein sets, etc. There is still a variety of medical devices that are out of the DCA’s purview. Currently, the Central Drugs Standard Control Organization (CDSCO) is the main medical regulatory body in India. It is responsible for implementing and enforcing the DCA. A new medical device body will be set up in India soon. International companies that are unfamiliar with India’s medical regulations and policies can contact PBM’s India medical device consultants for professional guidance.

PBM’s India medical device consultants have years of experience in the Indian medical device industry. We offer the best solutions to help your company succeed in the Indian medical device market. For inquiries on PBM’s India consultant services, please contact us or view PBM’s publications to find out more about the Indian healthcare market.