Medical Device Regulatory Services

Medical devices have been classified into A, B, C and D categories where the risk factor involved increases from A to D.

Class A – Low

Class B – Low-Moderate

Class C – Moderate-High

Class D – High

Low-risk devices include equipment like thermometers whereas high-risk devices include pacemakers, heart valves and others. The devices are further classified as surgical or non-surgical devices based upon their invasiveness. License for class A devices is easy to obtain as compared to class D devices.

The application for license to import Class A or Class B medical devices from Unregulated Jurisdictions (defined below) can be granted on the strength of a free sale certificate and either of published safety and performance data or clinical investigation in the country of origin. However, an application for import of Class C or Class D medical devices from Unregulated Jurisdictions can be granted only after its safety and effectiveness has been established through clinical investigation in India.

Unregulated Jurisdictions are jurisdictions other than Australia, Canada, Japan, European Union Countries, or the United States of America.

Similarly, for applications for grant of license to manufacture – Class A medical devices do not require prior audit by third party or official inspection; Class B medical devices require prior audit by third party but do not require official inspection, and; Class C or Class D medical devices require prior official inspection.

The application for manufacture of Class A or Class B medical device will be assessed by the State licensing authority whereas the application for manufacture of Class C or Class D medical device will be assessed by DCGI.