The Central Drugs Standard Control Organisation vide its notification dated 26th July 2021 has classified 66 interventional radiology devices based on the intended use, risk associated with device and other parameters as specified under the medical device rules 2017.
This includes devices such as bone sonometer, nuclear rectilinear scanner, nuclear tomography system, nuclear scanning bed, nonmetal ultrasonic monitor, ultrasonic pulsed doppler imaging system, spot film device, diagnostic x-ray high voltage generator, general purpose ultrasound imaging system, flexible ultrasound laparoscope, among others.
The 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.
Further, if the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use.
