Medical Device Process Validation Assures the Device Quality

by Sudhriti M | Jun 1, 2024 | Medical Device

Regulatory bodies require medical device manufacturers to confirm whether the finished product meets the set regulatory benchmark. Manufacturers need to have strict quality control systems to ensure the devices being manufactured comply with safety and quality...

CDSCO Registration : Start Medical Device Business in India Without CDSCO License

by Sudhriti M | May 31, 2024 | Medical Device

Medical devices form the backbone of the healthcare sector. They are used to perform real time diagnosis of medical conditions as well as treat and monitor them. Medical devices industry is a booming sector in India. There is a high unmet demand for affordable,...

Medical Device Grouping: Simplifying CDSCO License Application

by Sudhriti M | May 30, 2024 | Medical Device

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

by Sudhriti M | May 29, 2024 | Medical Device

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

by Sudhriti M | May 28, 2024 | Medical Device, Medical Device License Requirements

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...