The Central Drugs Standard Control Organization (CDSCO) has issued a reminder to manufacturers, importers, and testing labs about license and certificate renewal requirements under the Medical Devices Rules, 2017 (MDR). This circular was issued on May 15, 2024.
The circular states that licenses for manufacturing or importing medical devices, and registration certificates for quality management system (QMS) audits and medical device testing labs, are issued indefinitely.
However, timely payment of the requisite fees is crucial for maintaining license/ certificate validity. Non-payment by the stipulated deadline will result in the license/certificate being deemed cancelled.
Endorsements made on these licenses/ certificates also remain valid as long as the base document is valid.
Additionally, the circular urges all stakeholders to ensure timely payment of the necessary fees to the designated government account before the deadline to maintain product market continuity.
