CDSCO Updates Risk Classification for 119 Radiotherapy Devices Under MDR 2017

CDSCO Updates Risk Classification for 119 Radiotherapy Devices Under MDR 2017

The Central Drugs Standard Control Organisation (CDSCO) has released an updated risk classification list for 119 radiotherapy and oncology-related medical devices under the Medical Devices Rules (MDR), 2017.
This update aligns Indian regulations with global standards and clarifies how radiotherapy devices will be monitored, licensed, and controlled going forward.

This new list is especially important for manufacturers, importers, regulatory professionals, and healthcare institutions involved in radiotherapy devices in India, as it provides clearer guidance on device class, regulatory pathway, and licensing requirements.

Why Did CDSCO Update the Radiotherapy Device Classification?

CDSCO has been progressively updating medical device lists to ensure all categories of medical devices fall under MDR, 2017.
Earlier drafts were released in January 2017, but in 2025, CDSCO revisited radiotherapy, interventional radiology, oncology, and Class A devices to update classifications based on:

• International device classification practices

• Emerging new radiology & oncology device types

• Risk-based assessment

• Intended use criteria

This ensures the Indian medical device ecosystem remains aligned with global safety standards.

Breakdown of Risk Classification for Radiotherapy Devices

Under Rule 4, Chapter II of MDR 2017, radiotherapy devices are classified into Class A, B, C, and D based on risk level.

Class A (Low Risk)

Only one device falls under Class A:

• Compact thermoluminescent dosimetry electrometer

  • Used for measuring radiation dose in organs with high radiosensitivity (e.g., eyes).

Class B (Low-Moderate Risk)

Around 25 radiotherapy devices fall under Class B, including:

• Brachytherapy needle

• Laser irradiation therapy kit

• Interventional radiology percutaneous access kit

• Patient positioning devices for diagnostic imaging and radiotherapy

These devices pose moderate operational risk but require regulatory oversight.

Class C (Moderate-High Risk)

A total of 75 devices have been categorized under Class C.
Examples include:

• Brachytherapy applicators

• Conformal brachytherapy sources

• High-frequency hyperthermia systems

These devices directly interact with high-dose radiation and require higher regulatory scrutiny.

Class D (High Risk)

18 devices fall under Class D the highest-risk class.
These include:

• Absorbable tissue spacers for radiotherapy

• Manual and remote after-loading coronary brachytherapy applicators

• Therapeutic radionuclide systems

These devices deliver radiation to critical organs and need extensive safety tests.

How CDSCO Determines a Device’s Risk Class

CDSCO evaluates devices using:

• Intended use
• Duration of use
• Level of body contact
• Radiation exposure
• Invasiveness

This is guided by the First Schedule of MDR 2017, ensuring consistent classification across Class A-D.

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Why This New Classification Matters for Manufacturers and Importers

The updated radiotherapy device list:

• Defines the licensing pathway

• Indicates whether the device needs manufacturing, import, or loan license

• Helps regulatory teams prepare documentation

• Ensures compliance with safety and performance standards

• Supports device registration in India

A Dynamic List That Will Continue to Evolve

CDSCO noted that the radiotherapy classification list is dynamic and may be revised as new devices enter the market, new clinical needs emerge, or international standards change.

Regulatory Impact on Oncology & Radiotherapy Sector

This update strengthens India’s regulatory framework for:

• Radiotherapy equipment

• Oncology intervention tools

• Hyperthermia systems

• Brachytherapy accessories

Conclusion

The CDSCO’s updated classification for 119 radiotherapy devices marks a major step toward robust radiation-based medical care in India.
With clearer definitions under MDR 2017, manufacturers and importers can now align documentation, ensure compliance, and prepare more effectively for regulatory submissions.

For the complete CDSCO guidance document, please click here to view the official file.

Note:
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