It is now prominent that in order to maintain market access starting on ๐ข๐ฐ๐๐ผ๐ฏ๐ฒ๐ฟ ๐ญ, ๐ฎ๐ฌ๐ฎ๐ฏ all Class C and D medical devices must obtain aย #licenseย (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.
ย Theย #CDSCOย office has issued a circular on ๐จ๐๐๐๐ 12, 2023, to notify the medical device industry that they can begin submitting applications for Manufacturing and Import License for the ๐๐น๐ฎ๐๐ ๐ ๐ฎ๐ป๐ฑ ๐ ๐ฑ๐ฒ๐๐ถ๐ฐ๐ฒ๐ 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.
Theย #CDSCOย 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 theย #license(s) within the allotted period, they also reaffirmed that the application will be processed promptly.
This Circular states that starting on ๐ข๐ฐ๐๐ผ๐ฏ๐ฒ๐ฟ ๐ญ, ๐ฎ๐ฌ๐ฎ๐ฏ, all non-notified ๐๐น๐ฎ๐๐ ๐ ๐ฎ๐ป๐ฑ ๐ ๐ฑ๐ฒ๐๐ถ๐ฐ๐ฒ๐ 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.
