Risk-based classification
The rules classify medical devices by risk:
- Class A — low risk
- Class B — low to moderate risk
- Class C — moderate to high risk
- Class D — high risk
What this means for buyers
Whether a specific item is a notified medical device, and which licence applies, depends on the product and current notifications. Hospitals should ask the supplier or manufacturer for the applicable registration or licence details for each device. Building infrastructure such as wall panels is generally not a medical device, while equipment such as surgical lights may be.
Important
This page is a general overview for planning purposes. It is not legal or regulatory advice. Always refer to the current official text of the standard or regulation and your hospital's accreditation consultant.
Frequently Asked Questions
Who regulates medical devices in India?+
CDSCO under the Medical Devices Rules, 2017, together with state licensing authorities for certain classes.
