Written by Revision of Risk based Classification of Medical Devices – CDSCO
Central Drugs Standard Control Organisation (CDSCO) has revisited the existing risk based classification of Medical Devices in the categories of Cardiovascular and Neurological and added new entries based on their classification as per the First Schedule (Part I) of the MDR 2017
In this regard, CDSCO has issued a notification dated 1st April 2025, inviting all Stakeholders in the Medical Devices sector, such as Healthcare professionals, Manufacturers, Policymakers, Regulatory bodies, and other entities involved in the classification and regulation of medical devices to review the draft document and provide feedback within 30 days of publication to refine the risk-based classification framework for medical devices.
All concerned associations/stakeholders are requested to forward your comments by filling the Google form at https://forms.gle/62xF3BtXWC5pgD3TA within 30 days from the date of publication of this draft.
