Saurangi Shah / 25th February, 2022

Under The Provisions Of The Medical Devices Rule 2017, The DCGI Classifies Medical Devices Pertaining To Rehabilitation

Regulation/Guidelines

Medical Device,

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Summary:

The Drug Controller General India (DCGI) has categorized medical devices pertaining to rehabilitation based on their intended use, associated risks, and other factors provided in the Medical Devices Rules, 2017’s First Schedule.

The Drugs and Cosmetics Act of 1940, as well as the rules promulgated under it, govern the safety, quality, and performance of medical devices. The Central Government has notified Medical Devices Rules, vide G.S.R. 78 (F) dated 31.01.2017, for the regulation of medical devices with respect to import, manufacture, sale and distribution, clinical investigation, after consulting with the Drugs Technical Advisory Board. DCGI has done the classification of medical devices pertaining to rehabilitation.

Classification of Medical Devices (Pertaining To Rehabilitation)

Under the provisions of Medical Devices Rules, 2017, the medical devices are classified into three classes, i.e., A, B, and C. This new classification comes into effect from 26 July 2021. Table 1 gives the list of all medical devices and their classification pertaining to Rehabilitation.

S.No	Name of the Medical Device	Intended use	Classification India as per First Schedule part- 1 MDR 2017
1	Acupressure calf band	Intended to relieve low back pain, sciatica and piriformis syndrome.	A
2	Arthritis TENS system	Used as an adjunctive therapy in reducing pain and stiffness for rheumatoid arthritis or osteoarthritis	B
3	Back pulldown exerciser	Strengthens the muscles latissimus dorsi of the back through a repetitive pulldown motion performed with arms against a heavy weight.	A
4	Back row exerciser	trengthens the back muscles through a rowing motion performed with against a weight.	A
5	Back/leg/chest dynamometer, electronic	Electronic device intended to assess neuromuscular functioningof the back, chest and leg muscle during flexion.	B
6	Back/leg/chest dynamometer, mechanical	Non- Electric device used to assess neuromuscular functioning by measuring power exerted by the back, chest, and/or leg muscles during flexion.	A
7	Balance ball exerciser	ball specifically made to improve balance, mobility and strengthen the core.	A
8	Balance-training tongue electrical stimulation system	A biofeedback device for training balance by sensing body movements, giving out electrical stimuli to the tongue, for understanding body movement during exercise	B
9	Bed/chair electric massager	An electric chair to provide therapeutic massage for treating body aches and pain.	B
10	Bicycle ergometer	A device to measure the amount of energy (work) used by the muscle or group of muscles under specified conditions.	A
11	Bladder-emptying vibratory stimulator	A simulator initiates the urination process by creating small mechanical vibrations in the lower abdomen.	B
12	Blue/red/infrared phototherapy lamp	A device that emits blue, red, and infrared radiation intended for phototherapy for mild skin disorders, acne, wounds, and musculoskeletal spasms and pain.	A
13	Body elastic exerciser	An elastic resistance device that can be used to strengthen muscles or groups of muscles of the body, by using the repetitive motion of the specific muscle and joints	A
14	Body flywheel exerciser	A flywheel for performing strengthening exercise for major muscles groups of the body, using repetitive motion against its resistance.	A
15	Circulating-fluid thermal therapy system	A thermal therapy system that uses a pump to pass hot or cold fluid for treating localized pain, swelling and inflammation.	B
16	Cold compression therapy cervical spine collar	A cold compression collar for treating injury to the neck region, inflammation, stiffness or whiplash.	A
17	Cold/cool therapy gel	A gel that is used locally to provide a cooling effect to the muscle/ joints to reduce pain and swelling.	A
18	Cold-air therapy unit	A device that gives out a cold stream of air for treating pain and inflammation. Also intended for reducing thermal skin damage during dermatological laser treatment.	B
19	Core-body mechanical weight exerciser	A device intended for patients with a lumbar spine injury to perform controlled extension, contraction, twisting movements of the lumbar/ thoracic spine for testing, rehabilitation and improving movement.	A
20	Deep-tissue electromagnetic stimulation system	A device that is used to apply an electromagnetic (EM) field without heat to the tissues of the body, for treating issues like musculoskeletal disorders, pain, promoting soft and hard tissue wound healing.	B
21	Electric massager	A device used for respiratory therapy or physiotherapy to reduce muscular tension, arthritis pain and improve joint mobility.	B
22	Electromechanical orthopaedic extracorporeal shock wave therapy system	A device that produces electromechanical orthopaedic extracorporeal shock wave therapy (OEST) for treating muscular disorders.	C
23	Electronic goniometer/kinesiology sensor	A device used to test a patient’s range of movement of individual joints/limb/spine either before or after a medical or surgical procedure; to assess the degree of physical fitness.	B
24	Exothermic heat therapy pack	A heat therapy pack used with pressure to provide heat to the affected area, for reducing muscle spasms, cramps, muscle stiffness and pain	A
25	Finger/hand exerciser	A resistance or elastic device used to strengthen the muscles of fingers, hands by repetitive motion.	A
26	Foot sensorimotor therapy mechanical neurostimulator	A non-invasive device that improves somatosensory integration, primarily for improving motor functioning. Mainly used for balance disturbances in neurological disorders like Parkinson’s disease.	C
27	Gait analysis system	An analytical system that is used for studying patterns of running and walking in patients.	A
28	Hand dynamometer/pinch meter, electronic	An electronic device used to assess the neuromuscular functioning by measuring the force of the hand/arm muscles exerted by squeezing or pinching	B
29	Hand dynamometer/pinch meter, mechanical	A mechanical device used to assess neuromuscular functioning by measuring the force exerted by the hand and forearm muscles to squeeze an object.	A
30	Hydrotherapy treadmill	A hydrotherapy device that is partially immersed in water and provides treadmill walking exercise without impacting the patient’s joints.	A
31	Interferential electrical stimulation system	A device that is used to stimulate peripheral nerves via transcutaneous application. It mainly works by passing two electric voltages of different frequencies which produce a beating frequency at the treatment point.	C
32	Manual goniometer	A mechanical device used in clinical settings to measure the range of motion of the limbs in patient by measuring the angle of movement achieved in the joints.	A
33	Medium-wave diathermy treatment system	A device which uses electromagnetic energy in radio frequency bands (0.5 MHz to 1 MHz) transmitting to the body transcutaneously. The device produces therapeutic deep heat.	B
34	Microwave diathermy treatment system	An electromagnetic device that produces therapeutic heat 1 to 2 cm below the skin through transcutaneous transmission, via frequency around 2450 MHz (megahertz) to promote tissue healing and relieve pain .	B
35	Musculoskeletal infrared phototherapy unit	An infrared (IR) heat production device used for local treatment of musculoskeletal injury, to improve blood circulation to improve healing.	B
36	Musculoskeletal intense therapeutic ultrasound system	A device that delivers intense therapeutic ultrasound (ITU) waves to create ablative lesions in the skin subcutaneous tissues (muscle tendons)	C
37	Musculoskeletal/ physical therapy laser	A device that treats musculoskeletal conditions by noninvasive laser therapy [ e.g., infrared phototherapy, low-level laser therapy (LLLT) ] improves blood circulation to hasten healing or for non-needle acupuncture. Used for muscle pain, sports injury, joint disorders and connective tissues.	C
38	Parallel bar exerciser	A device made to assist users in maintaining good walking posture, especially persons with disability, paraplegia or a patient who suffered from a stroke and is relearning to walk.	A
39	Physical therapy massager	An electronic device to provide massages to large area as compared to hand-held devices.	B
40	Physical therapy paraffin wax bath	A physical therapy bath filled with liquid paraffin.	B
41	Physical therapy steam bath	A physical therapy steam bath for applying hot steam to patients.	B
42	Pulsed signal therapy system	A therapy for regenerating damaged cartilage, by stimulating the production of collagen that is found in healthy cartilage.	C
43	Short-wave diathermy treatment system	A device used to provide deep therapeutic heat through transcutaneous transmission of electromagnetic (EM) energy in the radio frequency bands (RF) of 13 MHz to 27.12 MHz	C
44	Standard treadmill, mechanical	A machine used to enable in-place jogging, walking or running to promote muscle redevelopment, promote weight loss and cardiovascular fitness, and restore movements of joints.	A
45	Standard treadmill, powered	An electronic used to facilitate in-place walking, running or jogging, to promote muscle redevelopment, restore joint movements, and promote cardiovascular fitness and weight loss.	A
46	Telemetric diagnostic spirometer	A portable device powered by a battery that is used to measure several respiratory-gas volumes and flow parameters for pulmonary function testing; to transmit the pulmonary function data to a healthcare professional(s) at a remote server via a communications device.	B
47	Therapeutic nuclear magnetic resonance system	A device that uses nuclear magnetic resonance (NMR) to influence cellular metabolism for the treatment of degenerative and pathological movements/support profile of body, especially in diseases of joints, bones and muscles ( e.g., cervical and lumbar spine, shoulders, elbow, etc).	C
48	Wall bars	A device permanently attached to the wall for training and rehabilitation to regain and improve balance, body movements, for strengthening the limbs and trunk.	A

Table 1: Classification of medical devices pertaining to Rehabilitation

Factors associated with the classification of medical devices

As per the sub-rule (3) of rule 4 of Medical Devices Rules, 2017, the DCGI has classified the Medical Devices based on the following factors:

Intended use
Risk associated with the device
Other parameters as per the First Schedule of Drugs and Cosmetics Ace, 1940.

The classification of medical devices is subjected to changes

As per the provisions of Medical Devices Rules 2017, this classification of medical devices pertaining to Rehabilitation can be revised from time to time.

Summary:

The Drugs Controller General (India) has listed a classification of medical devices used for rehabilitation in patients based on the parameters specified in the First Schedule of the Medical Devices Rules 2017.
The classification is based on the intended use and risks associated with using the medical device, and other parameters listed in the First Schedule.
This classification may be revised from time to time as deemed fit by the authorities.

Reference:

Classification of medical devices pertaining to Rehabilitation under the provisions of Medical Devices Rules, 2017-Reg. Accessed on Aug 18, 2021.

Saurangi is a food regulatory expert with 8 years of experience. She shares her knowledge and insights on regulatory updates, food trends, best practices, and news. Follow her for expert insights and practical advice on all things for food regulatory

Saurangi Shah

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Under The Provisions Of The Medical Devices Rule 2017, The DCGI Classifies Medical Devices Pertaining To Rehabilitation