(1) Medical devices other than in vitro diagnostic devices shall be classified on the basis of parameters specified in Part I of the First Schedule in to following classes, by the Central Government by notification in the Official Gazette-
(i) low risk - Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
(iv) high risk- Class D.
(2) In vitro diagnostic medical devices shall be classified and notified by the Central Government on the basis of parameters specified in Part II of the First Schedule in to the following classes,-
(i) low risk - Class A;
(ii) low moderate risk- Class B;
(iii) moderate high risk- Class C;
(iv) high risk- Class D.
(3) Manufacture of Class A medical devices referred in sub-rule (1) shall not be required to be licensed and such devices shall be self-regulated in accordance with the applicable standards.
(4) Where the manufacturer of Class A medical device referred in sub-rule (3) voluntarily applies for licence for conformance with the regulatory requirements under these rules, the same shall be assessed by the Notified Body for conformance with the relevant part of the Quality Management System in accordance with the procedure specified in the rules.
Medical device grouping.
6. Any person may, while applying for grant of licence for,-
(i) import for sale or for distribution;
(ii) manufacture for sale or for distribution;
(iii) sale, stock, exhibit or offer for sale;
group medical devices in the manner in accordance with the guidelines to be issued from time to time by the Central Licensing Authority by taking into consideration the technological changes or development in the field of medical devices and in biotech Highlight biotech Highlight biotech Highlight biotech Highlight 10 vitro diagnostic devices.
Essential principles for manufacturing medical devices.
7. Medical device manufacturer shall follow the essential principles of safety and performance of medical devices as may be specified in the guidelines issued by the Central Government from time to time keeping in view the contemporary scientific and technological knowledge and development.
Part III Authorities, Officers and Bodies.
Central Licensing Authority, State Licensing Authority and Notified Body.