Published Mon, 27 Feb 2023
The Central Drugs Standard Control Organization must issue the medical device importer with an import licence (CDSCO). In a notification published in 2020, the Ministry of Health and Family Welfare (MoHFW) mandated regulation for all medical devices listed in sub-clause 4 of clause b of section 3 of the Drugs and Cosmetics Act, 1940. The MoHFW issued instructions for this on 11.02.2020. According to the standards, medical device regulation should be implemented gradually.
Class A and Class B medical devices have a deadline of October 1, 2022, according to the notification; after this date, all devices would need to be licensed. For the sake of business continuity, several stakeholders and groups urged the government to postpone the implementation of the licencing regime until beyond October 1, 2022.
At this time, licencing class A and class B medical devices would interrupt the business flow and cause significant losses. Given the aforementioned issues, CDSCO decided that any importer or manufacturer who is currently importing or manufacturing a Class A or Class B medical device and who has submitted an application for that device to the Central Licensing Authority (CLA) or State Licensing Authority (SLA) on or before September 30, 2022 in accordance with the Medical Device Rules 2017, will have their application held valid for a period of three years.
As per the notification, if any existing importer importing Class A or B Medical Devices, submitted application to the authority on or before 30.09.2022, for grant of license, shall be deemed to be valid and can import up to 6 months from the date of issue of the order or till Authority takes decision, whichever earlier.
