Medical Device Grouping: Simplifying CDSCO License Application
Medical device grouping has been introduced to enhance the license application process in India. Grouping of medical devices expedites and simplifies the CDSCO registration and license application process. In this blog, we will delve into the grouping of medical...
Choosing an Indian Authorized Agent for Medical Devices: A Guide
Authorized agent for medical devices oversees a foreign manufacturer’s regulatory compliance and import operations in India. This blog will guide you on how to choose an “Indian Authorized Agent” for launching your medical device in India. Who is an Indian authorized...
Plant Master File for Medical Devices Registration
Central Drugs Standard Control Organisation (CDSCO) regulates the safety, efficacy, and quality of all medical devices in India. The aim of this regulatory body is to ensure substandard medical devices do not enter the Indian market. To market your medical devices in...
Quality Control in the Medical Device Assembly Process
With advancement in technologies, medical devices have become complicated and intricate with several parts. Manufacturers need to assemble various parts of the medical device to produce a functioning finished product. Hence, medical device assembly quality control...