India’s Central Drugs Standard Control Organization has issued new rules pertaining to all medical devices to be manufactured or sold in India…
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.
The original article doesn’t elaborate as to the nature of the approval process. Whether this will require the stringent standards of the US FDA is unclear. Attempts to locate information on the CDSCO homepage proved fruitless.
