India’s CDSCO Clarifies Which Devices Require Registration

India’s Central Drugs Standard Control Organisation (CDSCO) has issued an order listing those medical device categories that are subject to the same requirements as drugs under India’s Drugs and Cosmetics Act of 1940. 

Under section 3(b)(iv) of the Act, included are “such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.”

The order lists 14 devices categories that fall within that definition, and states that all other devices do not require any registration, license, permission or NOC under the Act for their import, manufacture, sale or distribution in India.  The 14 categories are: disposable hypodermic syringes, disposable hypodermic needles, disposable perfusion sets, in vitro diagnostics for HIV, HbsAg and HCV, cardiac stents, drug eluting stents, catheters, intra ocular lenses, I.V. cannulae, bone cements, heart valves, scalp vein sets, orthopedic implants and internal prosthetic replacements.

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