Medical Devices Rules, 2017
Also called: MDR 2017 · Topic: Statutory, Regulatory and Quasi-judicial Bodies · NCERT: Beyond NCERT
Meaning
The Medical Devices Rules, 2017 (MDR 2017) are rules made under the Drugs and Cosmetics Act, 1940. They govern medical devices, which are tools and equipment used to diagnose or treat patients. They cover how devices are made, brought into India (imported), sold and tested on people in trials. Devices are placed in four risk classes, from A (low risk) to D (high risk), and the higher the risk, the stricter the checks. The national drug regulator, the CDSCO (Central Drugs Standard Control Organisation), headed by the DCGI (Drugs Controller General of India), applies these rules.
Example
A company that imports a device placed inside the body faces stricter checks than one importing a simple low-risk product, because the first falls in a higher risk class. Imported devices can enter only through notified ports of entry, which are official entry points listed in the rules. CDSCO officers there check the papers and may take samples for testing. In 2026, the Union Health Ministry proposed adding 10 such points for drugs, medical devices and cosmetics: 8 inland container depots, 1 SEZ and 1 airport.
Don't confuse with
- Drugs and Cosmetics Rules, 1945: these are also made under the 1940 Act, but they cover drugs and cosmetics. The MDR 2017 covers medical devices.
- CDSCO: this is the regulator, an organisation. The MDR 2017 is the set of rules that the CDSCO enforces.