Mandatory Registration of Class C and D Medical Devices
Regarding the transition from mandatory registration to a licensing regime for Class C and D non-notified medical devices, effective from October 1, 2023, per GSR 102(E) dated February 11, 2020, under the Medical Devices Rules 2017:
Manufacturers and importers are reminded of the forthcoming shift, wherein these devices will move from mandatory registration to a licensing framework. Under the Medical Devices Rules 2017, obtaining a manufacturing license for Class C and D medical devices necessitates an inspection within 60 days of application by Medical Devices Officers (MDO) from the Central Licensing Authority (CLA) to ensure compliance with the Fifth Schedule of MDR 2017.
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To facilitate a seamless transition, it is recommended that manufacturers/importers initiate the process by applying for manufacturing/import licenses via the www.cdscomdonline.gov.in portal, submitting all required documents and fees as per MDR 2017. Applications will be promptly processed to ensure timely issuance of licenses, thereby avoiding any disruption to the supply chain of these medical devices and ensuring continued patient access.
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It becomes imperative for manufacturers and importers to proactively navigate this shift. Our team is committed to assisting clients in smoothly transitioning from mandatory registration to the new licensing framework, ensuring compliance with all regulatory requirements. By leveraging our expertise and resources, we aim to facilitate a seamless transition, thereby minimizing disruptions to the supply chain and maintaining uninterrupted access to vital medical devices for patients. Trust Operon Strategist to guide you through this regulatory landscape with precision and efficiency.
