Tech Park, Sector-49,
Gurgaon 122018 Haryana, India
+91 (0124) 491-1981
Boasting the world’s second largest population, India is a massive market offering a ton of potential for medical device manufacturers. While the Indian government has launched numerous programs to try and support R&D investments in their country, India still imports 90% of all sophisticated devices they need. Currently, it is the 4th largest medical device market in Asia, with their market size expected to grow by ~28% to reach $50 billion by 2025. Most of this growth can be attributed to citizens’ rising disposable income and significant government investments in healthcare infrastructure throughout the country.
Medical devices are overseen by the Central Drugs Standard Control Organization (CDSCO) which was established under the Drugs and Cosmetics Act of 1940 to regulate the importation, manufacturing and distribution of drugs in the country. While India has approved several amendments to the original Act, India’s regulatory process remains fairly unsophisticated and instead, provides manufacturers with a specific list of device types that require registration.
List of notified Medical Devices
*Seek guidance on application of categories
Information updated on June 14, 2021. Learn more about the updated regulations here.
Asia Actual is available to help navigate the complex medical device registration requirements and regulatory pathway for medical device and IVD distribution in India.
Contact Asia Actual for a free consultation discussing the potential for your medical device or IVD in the India medical market.
US: +1 512 898-9222
SG: +65 3138-4148