India Risk Classification for Radiotherapy as a Medical Device

Introduction – Radiotherapy Equipment Classification in India as per the Updated CDSCO Medical Device Rules

Radiotherapy devices play an important role in cancer treatment and other medical applications requiring precise radiation delivery. The Central Drugs Standard Control Organization (CDSCO) classifies these devices under the Medical Device Rules 2017 in India based on their intended use, associated risks, and regulatory requirements. The classification ensures that radiotherapy devices meet stringent safety and performance standards to protect patient health. By categorizing devices into appropriate risk-based classes (Class A, B, C, and D), the CDSCO medical device classification in India rules simplify the registration process while ensuring compliance with global best practices.

The recent updates to the Radiotherapy equipment classification in India reflect technological advancements and aim to align Indian regulations with international frameworks. These changes enable manufacturers to innovate while ensuring patient safety and regulatory efficiency.

India is Updating Existing Risk-Based Classifications for Radiotherapy Devices to ensure Medical Device Compliance in India

On January 6th, 2025, India's CDSCO published a draft annexure under notification MED-16014(12)/1/2022-eOffice making the following changes to the existing classification

• 26 new devices were added to the old list.
• 8 devices have been reclassified from Class A to Class A (non-sterile and non measuring).?
• 4 devices have slight name changes compared to the previous classification.
• 5 devices have not been included in the new classification.?

The complete list of updated classifications for Radiotherapy Devices, along with their intended use and revised risk categories, is provided in this document for easy reference.

To see the full list of Radiotherapy Equipment's Classification, click here

Conclusion: Medical Device Compliance in India for Radiotherapy Equipment

This article is based on notifications S.O 648(E), G.S.R 102(E), and MED-16014(12)/1/2024-eoffice, which outline the regulatory requirements for radiotherapy devices. The CDSCO medical device classification in India provides a structured framework based on the intended use, associated risks, and device-specific parameters.

Manufacturers must ensure compliance with the updated CDSCO medical device rules in India. The classification is dynamic and subject to periodic revisions. To navigate these changes and ensure smooth medical device registration in India, contact Morulaa [email protected] or visit our website for the latest updates.