In a groundbreaking move, the Central Drugs Standard Control Organisation (CDSCO) has unveiled an updated classification list for medical devices, ushering in a new era of regulatory excellence. This revision, encompassing categories like interventional radiology, radiotherapy, oncology, and Class A (non-sterile and non-measuring) medical devices, aligns with the Medical Device Rules (MDR), 2017, and international standards. It underscores India’s commitment to fostering innovation, enhancing patient safety, and streamlining the approval process.

What’s New in the Classification Categories?

The revised classification list is rooted in a risk-based framework, as specified under Rule 4(3) of Chapter II of the MDR, 2017. Here’s a snapshot of the changes:

• Interventional Radiology: 186 devices reclassified:
  
  • Class C: Angiography devices, cardiovascular MRI systems, full-body MRI systems.
    
    
  • Class B: Ultrasound and x-ray devices.
    
    
  • Class A: Grid for MRI (needle guide positioner).
    
    
    
• Radiotherapy: 114 devices now include:
  
  • Class D: Gamma knife for radiotherapy.
    
    
  • Class C: Brachytherapy devices.
    
    
    
• Oncology: 75 devices redefined:
  
  • Class C: Accelerator systems, cancer diagnostic probes.
    
    
  • Class B: Breast ultrasound imaging systems, facial prosthesis.
    
    
    
• Class A (Non-Sterile and Non-Measuring) Devices: 803 devices, such as abdominal support belts, absorbent cotton wool, and acupressure bands.
  
  

Your Voice Matters: Stakeholder Feedback Encouraged

To ensure the updated classifications address real-world needs, CDSCO has opened the floor to industry feedback. Stakeholders are invited to review the draft list and share their insights within 30 days of the announcement. Access the feedback form and draft list on the CDSCO website to participate in shaping the future of medical device regulation in India.

Why Is This Update a Big Deal?

Dr. Rajeev Singh Raghuvanshi, Drugs Controller General, emphasized, “The existing classification lists have been revisited, and new entries have been added in line with the First Schedule (Part I) of the MDR, 2017, as well as international classification standards.”

This updated framework aims to:

• Boost regulatory transparency.
  
  
• Enhance patient safety by addressing risks with precision.
  
  
• Bring Indian regulations in line with global standards.
  
  
• Unlock global market opportunities for Indian manufacturers.
  
  

How Bioexcel Simplifies Regulatory Challenges

At Bioexcel, we’re dedicated to helping medical device innovators navigate regulatory updates with ease. Our comprehensive services include:

• Expert Regulatory Consultation: Tailored strategies to adapt to updated classifications.
  
  
• Documentation Excellence: Seamless preparation and submission of technical files.
  
  
• Customized Training Programs: Equip your teams with knowledge and readiness for evolving regulations.
  
  
• Compliance Assurance: Guarantee adherence to both national and international standards.
  
  

Shaping the Future Together

The CDSCO’s reclassification initiative represents a critical step forward in India’s regulatory journey. By seeking stakeholder input, it paves the way for a more inclusive and globally competitive medical device sector.

At Bioexcel, we’re committed to empowering innovators to succeed in this dynamic landscape. Let’s collaborate to drive innovation, ensure compliance, and build a safer healthcare future. Contact us today to start your journey towards regulatory excellence.