MoHFW issues a circular on the regulations of all Class A & B Medical Devices under Licensing regime

Oct 06, 2022 | by TeamLease RegTech Legal Research Team

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Industry Specific ComplianceThe Ministry of Health & Family Welfare (MoHFW) on September 30, 2022, issued a circular on the regulations of all Class A & B Medical Devices under Licensing regime with reference to the notification published G.S.R. 102 (E) dated February 11, 2020, and said notification the Class A & B medical devices will be under licensing regime from October 01, 2022. 

The Ministry has received representations from the various Associations and Stakeholders requesting that the business continuity should not be disrupted due to the implementation of licensing regime w.e.f. October 01, 2022, for Class A & B medical devices. 

In view of this, the Ministry has decided that if an existing importer/manufacturer who is already importing /manufacturing any of Class A or Class B Medical Devices, has submitted an application to Central Licensing Authority or State Licensing Authority on or before September 30, 2022, as the case may be, for grant of import /manufacturing licence in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from the date of issue of this order or till the time, the Central Licensing Authority or State Licensing Authority.

[File No. 29/Misc/03/2022-DC (257)]


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