The Central Drugs Standard Control Organisation (CDSCO) has released a draft list of revised classifications for cardiovascular and neurological medical devices. Doctors, manufacturers, and stakeholders in the medical industry are invited to review and share their feedback by April 30, 2025.

What’s in the Draft?

• A total of 553 medical devices have been listed:
  • 351 Cardiovascular Devices
  • 202 Neurological Devices
• Devices are classified under four risk-based categories:
  • Class A – Low risk (25 devices)
  • Class B – Low to moderate risk (153 devices)
  • Class C – Moderate to high risk (151 devices)
  • Class D – High risk (221 devices)

This classification follows the guidelines of the Medical Devices Rules (MDR), 2017, and aligns with international standards from the IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force).

Why Is This Important?

This revised classification is part of India’s push to ensure:

• Better regulation of high-risk medical devices
• Improved patient safety
• Greater transparency in licensing and quality control
• Global alignment with international medical device norms

By properly classifying devices based on risk, the CDSCO can create better approval pathways, inspection protocols, and post-market surveillance systems.

How to Submit Comments?

CDSCO has provided a Google Form link (mentioned in their official notice) for collecting feedback. Industry professionals and doctors are encouraged to:

• Review the draft list
• Highlight corrections or concerns
• Submit suggestions for improvement

Deadline for submission: April 30, 2025

Who Should Respond?

• Doctors, especially cardiologists, and neurologists
• Medical device manufacturers and importers
• Hospital procurement departments
• Healthcare associations and regulatory experts

Final Thoughts

This is a key opportunity to ensure that the classification of life-saving devices is accurate, appropriate, and aligned with real-world clinical practice. Your voice can help shape India’s medical device ecosystem and protect patient safety.

📢 For Doctors and Industry Stakeholders:

👉 Download and review the draft list shared by CDSCO
👉 Submit your comments by April 30, 2025
👉 Collaborate with your medical associations or device partners to give informed feedback

Let’s work together to create a safer, smarter, and more regulated medical device environment in India.

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