Article
Medical Devices Rules: Faster Manufacturing Licence Approvals
The Union Ministry of Health and Family Welfare (the “Ministry”) has recently published a Draft Notification[1] in the Official Gazette proposing amendments to the Medical Devices Rules, 2017[2] (the “Rules”), promulgated under the Drugs and Cosmetics Act, 1940. The proposed amendments specifically target the statutory timelines prescribed for processing manufacturing licence applications across the four risk-based classifications of medical devices.
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