The medical device importer must obtain an import license from the Central Drugs Standard Control Organisation (CDSCO). In the year 2020, the Ministry of Health and Family Welfare (MoHFW) issued a notification stating all the medical devices mentioned under subclause 4 of clause b of section 3 of the Drugs and Cosmetics Act, 1940, have to be regulated.
For this, the MoHFW released guidelines dated 11.02.2020. The guidelines mentioned that the regulation of medical devices should be carried out in a phased manner. The notification had given a deadline of 01.10.2022 to Class A and Class B medical devices; post this date, all devices shall come under the licensing regime i.e. 1st of October 2022.