Download DCGI notice dated 06-07-2022 - Classification of Medical Device Pertaining to Rehabilitation, link is given below: The Drug Controller General India (DCGI) 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.

DCGI notice dated 06-07-2022 Classification of Medical Device Pertaining to Rehabilitation

The measure is to help the authority to bring all the medical devices under regulatory control.

The risk associated with Class A is perceived to be low, while Class B has low to moderate risk, Class C has moderate to high risk, and Class D has a 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 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 on January 1, 2018.

To read other classifications of Medical Devices, click below link

Classifications of Medical Devices under the provisions of MDR 2017

According to the notice dated 06-07-2022, the regulator has classified medical devices as under:

Under Class A:

- 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.

Under Class B:

- 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,
- Steam bath.

Under Class C:

- Electromechanical orthopedic 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 the body.

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