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New Delhi – The Central Drugs Standard Control Organization (CDSCO) has released a draft list proposing a revised risk-based classification for 553 cardiovascular and neurological medical devices, marking a significant step towards enhanced regulatory oversight in India. The CDSCO is now seeking feedback from stakeholders within a 30-day window, ending April 1, 2025.
The proposed revisions categorize the 553 devices into four classes, aligning with the Medical Devices Rules (MDR), 2017, and international regulatory standards. This initiative aims to ensure patient safety and improve the quality and efficacy of medical devices used in critical healthcare domains.
The breakdown of the proposed classifications is as follows:
- Class D (Highest Risk): 221 devices
- Class C (High Risk): 151 devices
- Class B (Moderate Risk): 153 devices
- Class A (Low Risk): 25 devices
The list includes 351 cardiovascular devices and 202 neurological devices. This comprehensive review reflects CDSCO’s commitment to adapting to evolving medical technologies and ensuring robust regulatory frameworks.
The CDSCO has provided a Google Form to facilitate the submission of stakeholder feedback. This streamlined approach aims to gather diverse perspectives, ensuring a thorough and informed decision-making process. The proposed changes are expected to significantly impact manufacturers, importers, and healthcare providers, fostering a more transparent and accountable medical device ecosystem.
This move underscores CDSCO’s ongoing efforts to strengthen the regulatory landscape for medical devices in India, ultimately prioritizing patient well-being.
Disclaimer: This news article is based on information available as of the provided source. Regulations and classifications are subject to change based on stakeholder feedback and further review by the CDSCO. Readers are advised to consult official CDSCO publications and regulatory documents for the most accurate and up-to-date information.
