India Issues New Rules On Medical Device Manufacturing

July 5, 2006
With the aim of increasing confidence in the manufacturing of medical devices in India, new guidelines were issues regarding the import, manufacture and sale of all sterile devices in India, according to a July 4 report on In-PharmaTechnologist.com . ...

With the aim of increasing confidence in the manufacturing of medical devices in India, new guidelines were issues regarding the import, manufacture and sale of all sterile devices in India, according to a July 4 report on In-PharmaTechnologist.com .

The guidelines, which were issued by India's Central Drugs Standard Control Organization (CDSCO), give manufacturers 60 days to obtain a license for medical devices they already manufacture in India. The current devices manufactured such as cardiac stents, drug eluting stents, catheters and orthopedic implants can be sold for up to six months until an application is approved or rejected.

Registration fees of $1,500 per manufacturing premise will be levied on device manufacturers with a fee of $1,000 per single device. This $1,000 fee would not be applicable of the device only varies in size or shape without any change in the material method of use.

For new companies entering the Indian market a license must be obtained prior to commencing manufacturing.

Importers and retail sellers of medical devices must obtain sale licenses from the State Licensing Authorities for the medical devices they distribute within the next three months.

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