CDSCO mandates license for import, manufacture of nebulizers, BP monitoring devices, digital thermometers, glucometer
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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.
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