In its latest move to better control the safety of medical devices for sale in India, regulators announced in September that a range of devices used in hospitals will be classified into six separate areas for the purpose of assessment and registration.
The classification areas published by Central Drugs Standard Control Organization (CDSCO) separate devices into those for pain management, nephrology and renal care, software systems, personal protective equipment, conduct of operations, and general hospital use. The classifications give every device a risk class rating of A to D and include a description of each device, its use, and its primary characteristics.
The classification system is designed to make it simpler to classify devices according to their risk and intended use. They are dictated by India’s medical device regulatory framework first put in place in 2017.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/