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CDSCO issues order on import of medical devices

Importers and manufacturers require to take licence for the import and manufacture of nebulizers, BP monitoring devices, digital thermometers and glucometer

Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare, Government of India, in its recent notification stated that importers of medical devices need to take import/manufacturing licence from Central Licensing Authority or State Licencing Authority in case the medical devices are imported. The medical devices mentioned are nebuliser, blood pressure monitoring devices, digital thermometer and glucometer. The rule comes into effect from January 1, 2021.

The CDSCO order also mentioned, “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.”

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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