What I am about to share with you is a guide to medical device regulatory classification. In this guide, I will provide you with a step-by-step approach for determining how your medical device will be ...

The Central Drugs Standard Control Organisation (CDSCO) has launched a new risk classification module on the drug regulator's online system for medical devices in order to simplify the regulatory ...

New Delhi: The nodal licensing and regulatory body for medical devices, CDSCO, has issued the draft list of revised risk-based classification of devices in the cardiovascular and neurological domains ...

Announcing a new article publication for BIO Integration journal. The development of a comprehensive regulatory model for medical devices is essential to ensure the safety, efficacy, and quality of ...

Medical device labeling is considered as important as classifying a product or creating an insulation diagram. In IEC 60601-1, labeling is deemed "a critical component of a medical device." 1 The ...