India Medical Device Registration

India's device market is about $2.5 billion. The Indian regulator of pharmaceuticals and some medical devices is the Central Drug Standards Control Organization (CDSCO). CDSCO is also commonly referred to as the DCGI.

The principal legislation governing drug and India medical device regulations is the Drugs and Cosmetics Act of 1940 (DCA). Both state and national authorities share the work of medical regulation. Under the DCA, there is no definition of “devices” and all medical regulation is of “drugs,” although there is legislation under development to regulate India medical devices separately from drugs.

Over time, a number of devices have been identified as needing product registration. In October 2005 and again in April 2009, a number of medical device categories have been officially regulated as drugs. These include spinal needles, endotracheal tubes, cochlear implants, annuloplasty rings, trachestomy tubes, heart lung packs, measure volume sets, heart valves, cardiac stents, orthopedic implants, and internal prosthetic replacements, among others.

For more information on India medical device registration and regulations, please see the following PBM publications and/or contact us to discuss your specific needs.

2011 India Medical Device Updates (webcast June 15, 2011)
India Medical Devices Manufacturers, Distributors, Exporters Directory 2011 (First of its kind!)
Indian Medical Device Manufacturers Push For Changes in Industry
Updates on the Medical Device Regulations in India
New Updates on India's Expanding Medical Device Market Webcast (webcast for sale)
Looking East for R&D and Clinical Trials
Doing Business in India (webcast for sale)
Update on India's Medical Device Markets (webcast for sale)
Strategies for Success in China, Japan, and India (webcast for sale)
India's Medical Markets Webcast (webcast for sale)