Medical Product Registration in India
Registration of Medical Devices in India
Registration of Pharmaceuticals/Drugs in India
The Indian medical regulatory system has become more complicated in recent years. New drugs can take a year or more to be approved for marketing. Medical devices traditionally did not need approval at all, but as of recently, some new devices require product registration.
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, which stands for Drug Controller General India.
All pharmaceuticals imported into India must have prior approval from the DCGI. There is no registration system designed for medical devices as a class, but some medical devices now require product approval as "drugs" before being marketed.
PBM's expertise will help you navigate the Indian regulatory system, achieve medical product registration, and access the huge Indian medical markets. PBM will help you register your medical product in a cost-effective and timely way.
For more information on medical product registration 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!)
- New Updates on India's Expanding Medical Device Market Webcast (webcast for sale)
- Looking East for R&D and Clinical Trials
- India Pharmaceutical Regulatory Report 2011 (publication for sale)
- Doing Business in India (webcast for sale)
- Pharmaceuticals in India: A Business and Regulatory Outlook
- Update on India's Medical Device Markets (webcast for sale)
- Strategies for Success in China, Japan, and India (webcast for sale)
- India's Pharmaceutical Markets (webcast for sale)
- India's Medical Markets Webcast (webcast for sale)
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