CDSCO mandates license for import, manufacture of nebulizers, BP monitoring devices, digital thermometers, glucometer
New Delhi: Through a recent notification the Central Drugs Standard Control Organization (CDSCO) has made it mandatory for importers and manufacturers to take license from the Central Licensing Authority or State Licensing Authority for the import and manufacture of nebulizers, BP monitoring devices, digital thermometers, and glucometer with effect from January 1, 2021.
The Ministry of Health & Family welfare, Government of India has notified the following devices as per S.O. 4671(E) dated December 27, 2019 which will be effective from 01.01.2021.
1. Nebulizer
2. Blood Pressure Monitoring Devices
3. Digital Thermometer; and
4. Glucometer
Accordingly, as per the said order the importers/manufacturers are required to take import/manufacturing licence from Central Licencing Authority or State Licencing Authority, as the case may be, for import/manufacture of above devices, w.e.f. 01.01.2021.
In the meantime, a representation has been received, requesting to extend implementation of the notification for another 3 to 6 months because a lot of procedural work is to be done such as resolution of queries, audit of facilities by the regulators and notified bodies, as the case may be, testing of products at the requisite testing labs etc.
"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 and devices referred to in rule 2 of the MDR, 2017 prior to commencement of MDR 2017," the notification added.
In view of the above, it has been decided that in case an existing importer/manufacturer who is already importing /manufacturing any of these devices, has submitted application to Central Licencing Authority or State Licencing Authority, 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 issue of this order or till the time, the Central Licencing Authority or State Licencing Authority, as the case may be. takes a decision on the said application, whichever is earlier.
To access the official notification, click on the link below-
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