In accordance with GSR 102(E), dated February 11, 2020, the Medical Device Rule 2017 will now be in effect beginning October 1, 2023, and non-notified medical devices of classes C and D that are currently required to be registered will be subject to a licensing system.
It is pertinent to mention that, as per Medical Device Rules (MDR) 2017, for grant of manufacturing license of class C & D medical devices, the inspection needs to be carried out within 60 days (about 2 months) from the date of application by the Medical Device Officers (MDO) of Central Licensing Authority (CLA), to ensure the compliance with Fifth Schedule of MDR 2017.
It is crucial to act fast and ensure a seamless transition to the new licensing system starting from October 1, 2023.
To avoid any delays or disruptions in the supply chain of these medical devices, it is highly recommended that Manufacturer/Importer should hire a trustworthy and experienced medical device regulatory consultant who can guide you through the process quickly and efficiently. This is where Operon can strategize your regulatory process for timely submission and approvals.
To ensure a smooth transition from voluntary registration to the new licensing system, manufacturers and importers are advised to apply for manufacturing or import licenses through the www.cdscomdonline.gov.in portal, accompanied by all necessary documents and fees according to MDR 2017. The applications will be processed promptly, and licenses will be issued within the specified timeline to avoid any disruptions in the supply chain of these medical devices and ensure patient access.
If you are a manufacturer or importer of class C and D non-notified medical devices in India, it is essential to prepare for the upcoming transition from mandatory registration to a licensing system starting from October 1, 2023.
We can ensure compliance with the Medical Device Rules (MDR) 2017 and a smooth application process for procuring the license from CDSCO.
Contact us today to learn how we can assist you in obtaining the necessary licenses and maintaining compliance with regulatory requirements.
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