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India Simplifies Licensing for Medical Device Manufacturing

India Simplifies Licensing for Medical Device Manufacturing

Per India’s Medical Device Rules, 2017 that came into effect in January this year, new licenses awarded for manufacturing and import of medical devices will not need periodical renewal and will remain valid until they are either suspended, cancelled, or surrendered. The licensee will need to pay a retention fee once every five years for the license to remain valid.

India’s federal regulator, the Central Drugs Standard Control Organization has launched Sugam, an online portal, to facilitate granting licenses for manufacturing, import, clinical investigation, sale and distribution of medical as well as in vitro diagnostics devices.

Authorities will inspect manufacturing sites  annually ensure compliance to the terms and conditions stipulated in the licenses. Manufacturers are required to follow a quality management system for manufacturing medical devices.

Blood pressure monitor

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