Regulatory Strategy for Medical Devices in India

The medical device market in India is about $2.5 billion. Developing the right regulatory strategy for medical devices in India is key.

Historically, only a few medical devices were regulated. In 2005, the Drug Controller General of India (DCGI) determined that several devices also needed registration, including heart valves, cardiac stents, orthopedic implants, and internal prosthetic replacements, among others. In 2009, 19 additional medical devices, such as endotracheal tubes, cochlear implants, annuloplasty rings, trachestomy tubes, heart lung packs, and hemodialysis tubing sets now also require registration.

Manufacturing medical devices in India also entails compliance to Schedule M of the DCA. This Schedule includes requirements on documentation and record-keeping, quality assurance and quality control system, sanitation, handling recalls, etc.

For more information on medical device regulatory issues in India, 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
Strategies for Success in China, Japan and India (webcast for sale)
Doing Business in India (webcast for sale)
Update on India's Medical Device Markets (webcast for sale)
India's Medical Markets Webcast (webcast for sale)