India Risk Classification for Interventional Radiology Products

Introduction – Interventional Radiology Equipment Classification in India

The classification of Interventional Radiology Products plays a vital role in ensuring their safety, efficacy, and regulatory compliance. These devices, which include cameras, scanners, nuclear probes, ultrasonic monitors, X-ray systems, and more, are important for accurate diagnostics and therapeutic procedures. The CDSCO classifies these devices under the Medical Device Rules 2017 in India, using a risk-based approach to assign each device into appropriate risk categories, ensuring compliance with established safety standards. This helps streamline the medical device registration in India and facilitates better market access for manufacturers and importers.

India is Updating Existing Risk-Based Classifications for Medical Devices

On January 6th, 2025, India's CDSCO published a draft annexure under notification MED-16014(12)/1/2022-eoffice, adding 140 new devices to the existing list of Interventional Radiology Products. This significant update also reclassified several existing devices, reflecting advancements in technology and regulatory requirements. For instance, devices such as the Scintillation (gamma) camera, Positron camera, and Nuclear scanning bed have been updated from Class A to Class A (Self Notified).

The Updated CDSCO medical device rules in India ensure alignment with international standards and facilitate a more robust regulatory framework for medical device compliance in India. The complete list of updated classifications for Interventional Radiology Products, along with their intended use and revised risk categories, is provided in this document for easy reference.

To see the full list of Interventional Radiology Products classification, click here

Conclusion: Medical Device Compliance in India for Interventional Radiology Equipment

The recent updates to the classification of Interventional Radiology Products, as part of the evolving regulatory framework under the Medical Device Rules 2017 in India, signify CDSCO’s dedication to align with global standards. The addition of 140 new devices and the reclassification of several products emphasize the importance of staying updated with the latest developments in CDSCO medical device classification in India.

For regulatory support and assistance in navigating these updates, Morulaa’s consultancy team is available to guide manufacturers through the medical device registration in India process, ensuring compliance with the Updated CDSCO medical device rules in India. Contact us at [email protected] for more information on these updates and the registration process.