Nov 26, 2012
India’s Central Drugs Standard Control Organization (CDSCO) has published new guidance documents covering registration and re-registration of notified medical devices, as well as guidances for manufacturing and import licensing.
Based on an initial analysis by Emergo Group, the medical device registration process in India generally remains the same. However, manufacturers should bear in mind several small changes.
Indian regulators are adding staff and resources to the Central Drugs Standard Control Organization (CDSCO) in order to enforce more stringent clinical trial guidelines for medical devices and pharmaceuticals.
The Drug Controller General (India) (DCGI) has announced plans to prescreen registration applications for medical devices and pharmaceutical products upon receipt beginning December 1, 2011.
Drugs Control General of India (DCG(I)), the country’s regulatory agency overseeing medical devices and pharmaceuticals, is currently lacking a director, stalling all