New Delhi : The Central Drugs Standard Control Organisation (CDSCO) has announced classification of medical devices pertaining to rehabilitation, physical support, dermatology and plastic surgery and interventional radiology under the provisions of Medical Devices Rules, 2017.
In separate notices issued for each category, the Drugs Controller General (India) has included 48 rehabilitation related medical devices including standard mechanical and powered treadmill, parallel bar exerciser, back pulldown exerciser, balance ball exerciser, bed/chair electric massager, bicycle ergo meter, body elastic exerciser, cold-air therapy unit among others into different classifications.
Another 38 medical devices for physical support, including the cervical spine collar, body arch traction table, balance board, cranial orthosis, elbow orthosis, finger orthosis, kinetic beds, orthopaedic bed, swivel-walker, among others were also announced under various classifications.
Dermatology and plastic surgery devices, a total of 56, were also brought under the classifications through another notice. Laparoscopy trays, implantable staple, haemostatic knife, general electrosurgical units, gastroscope general and plastic surgery, eye pad, electrosurgical device for over-the-counter aesthetic use, among others are classified with this notice.
Sixty six interventional radiology devices are also classified under another notice. This include 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.
Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules related to that. The medical devices are classified based on the intended use, risk associated with the device and other parameters specified in the first schedule of the Medical Devices Rules, 2017.