The Central Drugs Standard Control Organization (CDSCO) released a circular on 16 May announcing an extension for the importation of the Class C and D medical devices currently under application review with CDSCO. These classes of devices, which were to fall under the licensing regime starting from 1 October 2023 and the deadline was 1 April 2024, are now granted an additional 3 months for compliance.
The extension granted is due to concerns from associations and stakeholders requesting to avoid business continuity disruption because of the licensing implementation for class C and D medical devices.
Therefore, any importer or manufacturer who has been importing or manufacturing the involved medical devices, and has submitted the application on or before 30 September 2023, will be granted for the extension. The application will be considered valid, from the issuance date of this circular until the Central Licensing Authority reaches a decision, whichever comes earlier.
Contact us at info@arqon.com for more information.