The Central Drugs Standard Control Organisation (“CDSCO”) has reiterated that licenses for manufacturing or importing medical devices, as well as registration certificates for Quality Management System (“QMS”) audits by a notified body as well as for Medical Devices Testing Laboratory, are issued in perpetuity. This is conditional upon the timely payment of the requisite fee as stipulated under the Medical Device Rules, 2017, unless suspended or cancelled by the Licensing Authority.
Further, endorsements to these licenses and certificates will remain valid as long as the base license or certificate is valid. If the required fee is not paid within the specified timeframe, the license or certificate will be deemed cancelled.
The CDSCO urges all stakeholders in the medical devices sector to ensure timely payment of the requisite fee into the appropriate government account and to submit the necessary applications to the Licensing Authority. This is crucial for maintaining the validity of licenses or registration certificates under the Medical Device Rules, 2017, and ensuring the continued availability of products in the market.
A Copy of the Circular is linked below for your ease of reference.
Source: Central Drugs Control Standards Organization
