New Delhi : The Drug Controller General (India) has issued a notice classifying around 70 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.
According to the notice, the regulator has classified medical devices including acupressure calf band, back pull down exerciser, back row exerciser, back/leg/chest mechanical dynamometer, balance ball exerciser, bicycle ergometer, blue/red/infrared phototherapy lamp, body elastic exerciser, body flywheel exerciser, old compression therapy cervical spine collar, cold/cool therapy gel, core-body mechanical weight exerciser, exothermic health therapy pack, finger/hand exerciser, gait analysis system, mechanical hand dynamometer/pinch meter, hydrotherapy treadmill, 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, electric massager, electronic goniometer/kinesiology sensor, electronic 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 and steam bath, among others are classified under Class B of the regulation.
Electromechanical orthopaedic extracorporeal shock wave therapy system to treat musculoskeletal disorders, Foot sensorimotor therapy mechanical neurostimulator for reducing motor impairments and balance disturbances in patients with neurological or neurodegenerative disorders, interferential electrical stimulation system for stimulating peripheral nerves, musculoskeletal intense therapeutic ultrasound system to produce and deliver intense therapeutic ultrasound waves through the skin to create ablative lesions in subcutaneous soft tissues, musculoskeletal/physical therapy laser to improve blood circulation in the treated areas or for no needle acupuncture, pulsed signal therapy system to regenerate damaged cartilage, short-wave diathermy treatment system to provide a therapeutic deep heat within specific volumes of body, among others under Class C under 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.
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