INDIA: IVDs marketing clampdown

The new Indian Regulation on medical devices and IVDs brought significant restrictions to IVD devices.

The number of IVDs requiring complete technical documentation and registration with the local Regulatory Authority CDSCO (Central Drugs Standard Control Organization) in order to be marketed in the country is increasing.

The complete technical documentation shall include:

– the country of origin registration certificate;

– the production plant quality system certificate;

– the device complete technical details.

The import license issued by the CDSCO has unlimited validity, with a five-year deadline for the payment of its maintenance fees.

For more information:

http://www.cdsco.nic.in/writereaddata/Medical%20Device%20Rule%20gsr78E.pdf

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