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CDSCO Issues Guidelines on Medical Device License Retention

CDSCO Issues Guidelines on Medical Device License Retention


New Delhi, May 15, 2024 — The Central Drugs Standard Control Organization (CDSCO) has released a circular (F. No. MED-15/35/2024-eOffice) on the retention of medical device licenses and certificates under the Medical Devices Rules, 2017. Effective immediately, licenses for manufacturing or importing medical devices, as well as registration certificates for Notified Bodies and Testing Laboratories, will be issued in perpetuity, provided requisite fees are paid on time. This new directive emphasizes the importance of CDSCO medical device license retention.

The CDSCO emphasized that failure to pay the required fees within the stipulated timeframe will result in automatic cancellation of the licenses or certificates. Endorsements will also remain valid only if the base license or certificate is maintained.

Contact Morulaa to understand more on the retention time period and how to plan in advance to avoid any issues in your commercial activities in India. Email us on [email protected] or Click Here.

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