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Medical Device Regulation in India

BayBiotech.NET

At present, the Indian market for medical devices is largely unregulated and Medical devices can freely be imported into India. Solely, the key decision maker is either the doctor, or a private or government hospital that evaluates the device and imports it to India.

Although the FDA approved products are preferred because of their better
quality and performance, but since India is a price sensitive market, low priced, poor quality medical devices find a bigger and more favored market.

To ensure the quality of healthcare service and keeping the globalization of the clinical trials in mind, the Government of India is in the process of developing regulations for medical devices. A set of guidelines are expected to evolve that would bring a select group of medical devices under the regulatory framework.

In India, the authority regulating medical devices will be the Central Drug Standard Control Organization (CDSCO) in the Ministry of Health. The CDSCO is the authority, which lays down rules, standards and approves import and manufacturing of drugs, diagnostics, devices, and cosmetics. Currently, CDSCO’s functions are to establish the standards and regulations for drugs, blood and blood products, intravenous fluids, and vaccines. With added responsibility of regulating the medical devices industry, CDSCO will be the approving authority for import, manufacture and sale of medical devices in India.
To read more on the topic follow the link: http://www.cdsco.nic.in

Reference:

1. http://www.trade.gov/td/health/india_med_registration05.pdf

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