(1)Medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, in the following classes, namely:-(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 on the basis of parameters specified in Part II of the First Schedule, in the following classes, namely:-(i)low risk - Class A;(ii)low moderate risk- Class B;(iii)moderate high risk- Class C;(iv)high risk- Class D.(3)The Central Licencing Authority shall, classify medical devices referred to in rule 2, based on the intended use of the device and other parameters specified in the First Schedule.(4)Based on the classification referred to in sub-rule (3), class wise list of medical devices shall be published on the website of the Central Drugs Standard Control Organization:Provided that the Central Licencing Authority may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device.
