The Central Drugs Standard Control Organisation on 26th July 2021 has classified 55 medical devices pertaining to Dermatological & Plastic Surgery such as organ bag, surgical camera, and accessories, Implantable ligating clip, Wound autofluorescence imaging device, Carbon dioxide laser, Cryosurgical unit and accessories etc.
These medical devices are classified into risk classes of A, B and C based on the intended use, risk associated with device and other parameters as specified under the medical device rules 2017.
Application of the classification provisions shall be governed by the intended purpose of the device and if the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used.
