Quality Systems for Medical Devices in India

More and more Western medical device companies are sourcing and/or manufacturing their medical devices or components in India. Hence, quality in India is a key issue.

Good Manufacturing Practices (GMP) for medical devices are described in Schedule M and Schedule M III of the Drug Cosmetics Act (DCA). Schedule M describes the quality assurance, self-inspection and/or quality audit, and quality control systems requirements.

Depending on the type of medical device, the DCGI and the State FDA will approve or determine the medical device licensing process. The application for a manufacturing license may include manufacturing processes, product details, information on staff, etc. In addition, there are many state/local level licenses needed to manufacture a medical device. Therefore, determining the regulations of a particular Indian State is also important when deciding on a manufacturing site location.

For more information on Indian medical device quality standards, 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 for sale)
Looking East for R&D and Clinical Trials
Sourcing Medical Devices in Asia 2010 (publication for sale)
Update on India's Medical Device Markets (webcast for sale)