India Risk Classification for Rheumatology as a Medical Device

Introduction – Rheumatology Equipment Classification in India

This article discusses the latest rules for Rheumatology equipment classification in India as a Medical Device under the Medical Device Rules 2017 in India. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued a substantial risk-based classification for all Rheumatology Products. All Rheumatology Products need to be registered to comply with the Medical Device Rules 2017 as per the Updated CDSCO medical device rules in India.

India is Updating Existing Risk-Based Classifications for Medical Devices

On January 6th, 2025, the Central Drugs Standard Control Organization (CDSCO) published a draft annexure revisiting the existing classification lists under notification number MED-16014(12)/1/2022-eoffice. There are no changes in the Rheumatology equipment classification in India?as outlined in the previous notifications.

Below is a table that helps manufacturers classify their products and apply with the Indian Health Ministry accordingly.

Conclusion: Medical Device Compliance in India for Rheumatology Equipment

The CDSCO has classified the Rheumatology devices as per the medical device registration in India based on the intended use, risks associated, and other parameters specified with the device. The table above outlines the general intended use for each device. Manufacturers must specify any unique intended uses for their products. Adhering to the Medical Device Rules 2017 in India is important for fulfilling regulatory obligations for medical device compliance in India.

To obtain MDR in India, contact Morulaa. We at Morulaa will help you understand the latest rules for Rheumatology as a Medical Device in India. We are a turnkey solution provider with an in-house Medical Device Consultancy team to conduct medical device registration in India. To comply with the regulations, contact us at [email protected]. Visit our website to learn more about the latest rules and Updated CDSCO medical device rules in India.