The Ministry of Health and Family Welfare (MoHFW) on October 21, 2022, issued a notification regarding the implementation of Medical Devices (fifth amendment) Rules, 2022 vide G.S.R 754(E) dated September 30, 2022.
Wherein provision for a Registration Certificate to sell, stock, exhibit, or offer for sale or distribute a medical device including in vitro diagnostic medical device, as an alternative to Drugs Sale License has been implemented with effect from September 30, 2022.
Regarding the application of these rules, several stakeholder representations have been received claiming that their application in physical form is not being accepted. According to the aforementioned regulations, the applicant may submit an application for a Registration Certificate in Form MD-41 to the relevant State Licensing Authority (SLA), and the SLA, upon fulfilling the requirements, shall issue a Registration Certificate in Form MD-42 to sell, stock, exhibit, offer for sale, or distribute a medical device, including an in vitro diagnostic medical device, within the nation.
Accordingly, all the SLAs are requested to accept the applications in hard copy from such applicants of medical devices and dispose of the application expeditiously on priority and ensure uninterrupted access or supply of such medical devices.
[Notification No. 29/Misc/03/2022-DC (269)]
