The Central Drugs Standard Control Organization (CDSCO) has issued a Circular in response to representations from various associations and stakeholders to ensure business continuity for the industry. The Circular states that any existing importer or manufacturer currently producing Class C & D medical devices, who submitted their application to the Central Licensing Authority (CLA) before 30th September, 2023 (under the Medical Devices Rules 2017), will have their application deemed valid. Such importers or manufacturers may continue to import or manufacture the specified devices until 16th August, 2024, or until the CLA makes a decision on their application, whichever occurs first.
Consequently, importers or manufacturers of Class C and D medical devices are permitted to continue their operations for an additional three months, even if their license application is still pending with the CLA for decision.
A Copy of the Circular is linked below for your ease of reference.
Source: Central Drugs Control Standards Organization
