Importers and manufacturers required to take licence from the Central Licensing Authority or State Licensing Authority for the import & manufacture of nebulizers, BP monitoring devices, digital thermometers, and glucometer with effect from Jan 1, said Central Drugs Standard Control Organisation.
An order reads, "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, & notified bodies, as the case may be, testing of products at the requisite testing labs".
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 & Cosmetics Rules for the substances & devices referred to in rule 2 of the MDR, 2017 prior to commencement of MDR 2017.
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