Medical Devices Rules, 2017

The Medical Devices Rules, 2017 place medical devices into four classes according to the risk associated with their intended use. The framework applies separately to ordinary medical devices and in vitro diagnostic medical devices, while using the same ascending classes from A to D.

Four risk classes

Under Rule 4, classification is based on the device's intended use and the parameters specified in the First Schedule.

• Class A covers low-risk devices.
• Class B covers low-to-moderate-risk devices.
• Class C covers moderate-to-high-risk devices.
• Class D covers high-risk devices.

Basis of risk assessment

For devices other than diagnostics, classification considers factors such as invasiveness, duration of contact, whether the device is active or implantable, and its interaction with the body. For in vitro diagnostic devices, risk reflects the intended diagnostic purpose and the possible consequences of an incorrect result for the individual or public health.

• Where more than one classification rule applies, the rule resulting in the higher risk class governs.
• Accessories and devices used together are classified according to their own intended purposes.

Regulatory consequence

The classification determines the intensity and institutional level of regulatory oversight. Manufacturing licences for Classes A and B are handled by the State Licensing Authority, while those for Classes C and D are handled by the Central Licensing Authority.

• Higher-risk devices are subject to more rigorous scrutiny before licensing and stronger conformity assessment requirements.
• Import licensing is administered by the Central Licensing Authority.