Post Market Surveillance of Medical Device in India
Medical devices are essential components of the healthcare system. Hence, strict vigilance of their efficacy and safety is necessary. All safety concerns cannot be identified during the pre-market testing phase. Post market surveillance helps identify any potential...
Basics and Tips for Medical Devices Registration in India
India is a lucrative market for medical devices business. Indian medical devices industry, one of the top 20 markets in the world, is the 4th largest market in Asia. The Indian government is aimed at establishing India as a hub for manufacturing affordable,...
Risk Management in Medical Devices: Navigating CDSCO Regulations
Medical devices are integral to modern healthcare. From simple tools to complex machinery, they aid in diagnosis, treatment, and overall patient care. However, with this utility comes the undeniable responsibility of ensuring their safety. In India, the Central Drugs...
CDSCO Classification of Rehabilitation Medical Devices
The Central Drugs Standard Control Organisation (CDSCO) is the regulatory authority for the medical device industry in India. On 13 September 2021, CDSCO specified 60 Rehabilitation medical devices. This list includes devices such as Exothermic heat therapy packs,...