Sunday, August 1, 2021

License required to import, manufacture medical devices – ET HealthWorld

New Delhi: Importers and manufacturers required to take licence from the Central Licensing Authority or State Licensing Authority for the import and manufacture of nebulizers, BP monitoring devices, digital thermometers, and glucometers with effect from January 1, said Central Drugs Standard Control Organisation.

“Representation has been received requesting to extend the implementation of the notification for another three to six months because a lot of procedural work is to be done such as the resolution of queries, an audit of facilities by the regulators, and notified bodies, as the case may be, testing of products at the requisite testing labs,” reads an order.

In this regard, it may be pertinent to mention that Rule 97 of Medical Device Rules (MDR) 2017 provides details about applicability of the said rules in respect of various actions/operations undertaken under Drugs and Cosmetics Rules for the substances and devices referred to in rule 2 of the MDR, 2017 prior to commencement of MDR 2017.

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