DCGI notifies classification of 60 medical devices related to rehabilitation

New Delhi, August 11, 2022 :

The Drug Controller General of India (DCGI) has issued a notice classifying 60 medical devices pertaining to rehabilitation under the provisions of Medical Devices Rules, 2017.

The decision comes as the latest in the drug regulator’s efforts to classify the medical devices sold in the country based on the perceived risk of the product type and its use in patients. The measure is to help the authority to bring in all the medical devices under the regulatory control. In July, the drug regulator classified a group of 70 medical devices pertaining to rehabilitation. Some of the same devices are mentioned in the new notice issued on August 4, also.

According to the notice, the regulator has classified medical devices including Acupressure calf band, back/leg/chest mechanical dynamometer, bicycle ergometer, blue/red/infrared phototherapy lamp, cold compression therapy cervical spine collar, cold/cool therapy gel, core-body mechanical weight exerciser, exothermic heat therapy pack, gait analysis system, mechanical hand dynamometer/pinch meter, hydrotherapy treadmill, manual goniometer, parallel bar exerciser, silicone prosthetic ear, silicone prosthetic nose, external assembled lower limb prosthesis, external limb prosthesis socket liner, finger/thump prosthesis, truncatal orthosis, prosthesis external arm, congenital hip dislocation abduction splint, Denis brown splint, arm sling, crutches, abdominal support, among others under Class A of the regulation.

Arthritis TENS system, back/leg/chest electronic dynamometer, balance-training tongue electrical stimulation system, bed/chair/electric massager, bladder-emptying vibratory stimulator, circulating-fluid thermal therapy system, cold-air therapy unit, deep-tissue electromagnetic stimulation system, electronic goniometer/kinesiology sensor, electric hand dynamometer/pinch meter, medium-wave diathermy treatment system, microwave diathermy treatment system, musculoskeletal infrared phototherapy unit, physical therapy massager, physical therapy paraffin wax bath, physical therapy steam bath, telemetry diagnostic spirometer, upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components, among others have been classified under Class B of the regulation.

Electromechanical orthopaedic extracorporeal shock wave therapy system, foot sensorimotor therapy mechanical neurostimulator, interferential electrical stimulation system, musculoskeletal intense therapeutic ultrasound system, musculoskeletal or physical therapy laser, pulsed signal therapy system, short-wave diathermy treatment system, therapeutic nuclear magnetic resonance system, among others are classified under Class C of the regulation.

None among the 60 devices were classified as Class D of the regulation.

The risk associated with the Class A is perceived to be low, while B has low to moderate risk, C has moderate to high risk and D has the high risk, according to the widely accepted classification criteria.

The safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules and for the regulation of medical devices for imports, manufacture, clinical investigation, sale and distribution, the Central Government has notified the Medical Devices Rules, 2017, which commenced from January 1, 2018. Pharmabiz