The Central Drugs Standard Control Organisation vide its notification dated 6th August 2021 has classified 101 medical devices pertaining to Radiotherapy such as Medical charged particle radiation therapy system, Absorbable perirectal spacer, Applicator for bile duct manual brachytherapy, Applicator for pancreas manual brachytherapy etc.
These medical devices are classified on the basis of parameters in the following classes, namely:—
- low risk – Class A;
- low moderate risk- Class B;
- moderate high risk- Class C;
- high risk- Class D.
Based on the above classification, class wise list of medical devices shall be published on the website of the Central Drugs Standard Control Organisation: 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.
