India Eases Medical Device Rules: EU Added to Waiver List
India has eased medical device rules by removing the requirement for a separate loan licence when manufacturers outsource sterilisation. However, the sterilisation facility should hold a valid licence, with a six‑month transition period to update labels. Additionally,...
CDSCO License for Class C and D Ophthalmic Medical Devices
Ophthalmic medical devices play a critical role in diagnosis, treatment, monitoring, and surgical management of eye-related diseases and vision disorders. Given their role in healthcare industries, regulatory bodies regulate ophthalmic medical devices to ensure...
Draft Drugs, Medical Devices & Cosmetics Bill 2026: India’s Pharma & Medical Device Regulation Overhauled
Government plans to replace the Drugs & Cosmetics Act, 1940. This highlights a major regulatory shift. The Draft Drugs, Medical Devices & Cosmetics Bill, 2026 aims to replace the 1940 Act. It will consolidate drug, device, and cosmetic regulation under one...