In a move that is aimed at bringing all medical devices under the ambit of regulation in a phased manner, on February 11th, 2020, the Ministry of Health and Family Welfare published the Medical Device Rules, 2020 as an amendment to the Medical Device Rules, 2017 requiring the registration of all non-Notified medical devices over a 18-month period with the Central Drugs Standard Control Organization (CDSCO).
These Medical Device Rules, 2020 will come into full effect on April 1, 2020. The notification calls for a voluntary registration within a period of 18 months from April 2020 and obtaining manufacturing/import license under Medical Device rules within a span of 36 months for class A&B devices and 42 months for class C&D devices. After the 18 months period for temporary registration all non-Notified medical devices must be registered (i.e., by October 1, 2021) in the CDSCO’s on-line portal and shall bear the temporary registration number on the label of the product . The roadmap was earlier released for stakeholder comment on 18 October 2019 and will ensure that the safety and post market surveillance concerns surrounding medical devices will now be streamlined and timely action taken.
Mr Himanshu Baid, Chairman, CII Medical Technology Division and Managing Director, Polymedicure, said “CII Medical Technology Division welcomes this move, as this will ensure that all medical devices available will be safe and effective. The temporary registration application for devices that are currently unregulated will require basic administrative documents and basic product information. The registration process carries no government processing fees and does not expire till the manufacturer/importer obtain the import/manufacturing licence within a period of 36 and 42 months for class A,B and C,D devices respectively, the temporary registration may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by an Import/ Manufacturing License. Once registered the local registration holder will be required to notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SEA) occurring in India.”
12 February 2020