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Regulation of Medical Devices in India

Regulation of Medical Devices in India

At the federal (central or union) government level in India, medical device are regulated by the Central Drug Standards Control Organisation (CDSCO) under the Ministry of Health and Family Welfare. Some Indian states have additional regulatory bodies.

India defines a medical device as one intended for internal or external use in the diagnosis, treatment, migration or prevention of a disease or disorder in humans or animals. Certain devices such as intra-uterine contraceptive devices, tubal rings, condoms, sutures/staples/ligatures, blood bags are regulated as “drugs” and registration is required.

The Indian government proposed regulatory guidelines for pre-market approval of medical devices in 2008, through amendments to the 68 year old Drug and Cosmetics Act and the ultimate expectation is to create a new agency to regulate medical devices, the Central Licensing Approval Authority. The bill is moving slowly through the regulatory process and even after it becomes law, the government will need to define specific regulations and processes on its administration.

As of now, only 21“notified” categories of devices are required to register prior to sale, this includes disposable hypodermic syringes and needles, disposable perfusion sets, in-vitro diagnostic devices for HIV, HBSAG and HCV, cardiac and drug-eluting stents, catheters and IV cannulas, bone cements, intra-ocular lenses, orthopedic implants, prosthetic replacements, and heart valves. Devices not under the notified categories can be sold without registration. Also, devices already approved in their home countries by the U.S. FDA, the European CE, Australian, Canadian, or Japanese regulators are readily importable with limited paperwork.

If registration is required it can take 3-6 months to process after submittal of complete and accurate documentation and fees. Registration is valid for 3 years and renewal applications need to be submitted well in advance of expiry.

Amritt’s Medical Device practice can assist and guide in the selection of a local authorized agent to register your medical device if needed. See separate pages on Amritt services to find, vet and manage medical device distributors in India.

 

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