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...

Guide to Starting a Class A Medical Device Business in India

by Sudhriti M | May 21, 2024 | Medical Device

Medical devices form the backbone of the healthcare sector. Medical devices sector of India has been recognised as the sunrise sector. Given the potential of India’s medical device industry, entities are trying to establish a medical device manufacturing business in...

CDSCO Regulations for Bone Marrow Cell Separator in India

by Sudhriti M | May 21, 2024 | Medical Device

India is witnessing a high prevalence of blood and bone marrow diseases, such as aplastic anaemia, leukaemia, and multiple myeloma. Bone marrow cell separator is a standard laboratory medical device used to diagnose and monitor these diseases. The treatment and...

Medical Devices and IVDs: CDSCO Regulations in India

by Sudhriti M | May 21, 2024 | Medical Device

Medical devices and IVDs are pivotal components of the healthcare sector. They are vital for effective healthcare delivery. Demonstration of safety and efficacy of these devices is crucial prior to marketing these products for use. To ensure improved outcome and...

CDSCO Medical Device MD13 Test License in India: A Detailed Guide

by Sudhriti M | May 18, 2024 | Medical Device

Companies planning to test the quality and safety of medical devices before full-fledged sale need to obtain a test license. A CDSCO test license will enable manufacturers/importers to manufacture or import small quantities of medical devices for evaluation purpose....