It is now prominent that in order to maintain market access starting on š¢š°šš¼šÆš²šæ š, š®š¬š®šÆ all Class C and D medical devices must obtain a #license (Manufacturing/Import). According to GSR 102 (E) dated February 11, 2020, the mandatory registration phase is currently in effect for non-notified Class C and D devices.
The #CDSCO office has issued a circular on šØšššš 12, 2023, to notify the medical device industry that they can begin submitting applications for Manufacturing and Import License for the šš¹š®šš š š®š»š± š š±š²šš¶š°š²š that have not been notified. This circular has been issued to ensure that manufacturer(s) operations don’t stop while they wait for the approval of their Manufacturing or Import License application.
The #CDSCO clarified that the manufacturers could begin submitting applications through the CDSCO Medical Device Online Portal with the required paperwork and costs in accordance with India MDR 2017. In order to give the #license(s) within the allotted period, they also reaffirmed that the application will be processed promptly.
This Circular states that starting on š¢š°šš¼šÆš²šæ š, š®š¬š®šÆ, all non-notified šš¹š®šš š š®š»š± š š±š²šš¶š°š²š would be subject to licensing requirements. The relevant options to proceed with submitting the aforementioned applications are also displayed on the Online Portal for Medical Devices.
The Circular can be found here.
If you are a manufacturer of Class C & D medical devices, and looking for someone to guide and assist you in obtaining #license, please feel free to reach out to us at contact@8chealthcare.com.
