CDSCO classifies In-Vitro Diagnostic Medical Devices under Medical Device Rules, 2017
This classification has been undertaken on the basis of intended use, risk associated with the device and other parameters. CDSCO has updated its List of In-Vitro Diagnostic Medical Devices (IVD Analyzers) and List of In-Vitro Diagnostic Medical Devices (IVD Instruments). It has also added List of In-Vitro Diagnostic Medical Devices (IVD- Specimen receptacle) and List of In-Vitro Diagnostic Medical Devices under provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017.
CDSCO permits applicants of Class C & D Medical Device Licences to continue Operations
The Central Drugs Standard Control Organisation (CDSCO) has issued a circular clarifying that an existing manufacturer or importer of Class C or Class D medical devices can continue to import/ manufacture these devices till 12th April, 2024. This circular has been issued with the view to limit the disruption to business continuity.
CDSCO publishes List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious for May 2023
This list includes a total of 28 drugs, medical devices and cosmetics that are identified as being deficient. Out of these 28 samples, 27 were declared as not of standard quality and 1 was declared spurious.
Medical Devices (Amendment) Rules, 2023
These Rules aim to enhance the regulatory framework governing medical devices in the country. They provide for the establishment and designation of State Medical Devices Testing Laboratories, further empowering the testing and evaluation of medical devices.
