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...
5 Tips to Overcome Common US FDA 510k Clearance Barriers
Owing to incorrect application, thousands of US FDA 510(k) submissions are rejected. In this blog, we have provided a detailed guide on how to overcome common FDA 510k clearance barriers. Furthermore, in certain cases, the applicants cannot complete their FDA 510k...