India’s Ministry of Health and Family Welfare (MoHFW) and the Central Drugs Standard Control Organization (CDSCO) are the main regulatory bodies that are responsible for overseeing pharmaceuticals and medical devices within India.
Medical devices and in vitro diagnostics (IVDs) in India are regulated under the Medical Device Rules that came into effect in 2018. Medical devices are categorized into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk), or Class D (high risk) devices. IVDs are categorized separately using the same class names and risk levels from Class A to Class D.
The Central Licensing Authority is the authoritative body that oversees the importation of all classes of medical devices; the manufacture of Class C and D medical devices; the clinical evaluation and approval of investigational medical devices; and the clinical evaluation and approval of new IVDs. The responsibility of overseeing the manufacture of Class A and B medical devices and the sale, stocking, exhibiting, and distribution of all classes of medical devices is delegated to state licensing authorities.
Both new Indian market entrants as well as companies currently selling such devices in the country will have to register with CDSCO by the April 2020 deadline in order to continue legally marketing these products. And we are here to help you.