Background – Regulatory Affairs for Medical Devices
This article deals with the Regulatory Affairs for Medical Devices. This amendment is for the Intended Use for Medical devices in Rehabilitation. The Central Drugs Standard Control Organization (CDSCO) controls the Regulatory Affairs for Medical Devices and is the Advisory Body for Pharmaceuticals and Medical Device Registration in India wherein all Notified Medical Products are regulated by them. The responsibility lies with the Drugs Controller General of India (DCGI) under the CDSCO for product approvals in India. The CDSCO is responsible for approval and regulation Drugs, Cosmetics, IVD and Medical Device Registration, control over the quality of Imported Devices, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. Manufacturers can leverage their approvals in the US, Canada, Europe, Australia or Japan for the Medical Device Registration Process in India. To know more on the Regulatory Affairs for Medical Devices – Click Here
What is The Amendment:
With several changes being constantly introduced by the CDSCO, this current change is mainly dealing with the Intended Use of Various Products & Regulatory Affairs for Medical Devices. The CDSCO has classified the medical device registration in India, Appendix A based on the Intended Use, Risks Associated and Other Parameters Specified with the device. The General intended Use has been given by the CDSCO, however, Specific Intended Use can be given by the manufacturer. This list is dynamic and is subject to changes. The following is the table which has been published by the CDSCO for products dealing with Rehabilitation along with their Intended Use.
Appendix –
| S.No. | Medical Device Name | Intended Use | Risk Class |
| 1 | Acupressure calf band | Intended to wear around the calf to apply pressure to an acupressure point to relieve low back pain, including sciatica and piriformis syndrome. A Non powered belt like device. | A |
| 2 | Arthritis TENS system | Intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneous). | B |
| 3 | Back pulldown exerciser | Intended to strengthen the muscles of the back (especially the latissimus dorsi) through a repetitive pulldown motion performed with the arms against the force of a weight. | A |
| 4 | Back row exerciser | Intended to strengthen the muscles of the back through a repetitive rowing motion (as in rowing a boat with oars) performed with the arms against the force of a weight. | A |
| 5 | Back/leg/chest dynamometer, electronic | Powered device intended to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion. | B |
| 6 | Back/leg/chest dynamometer, mechanical | Non powered device intended to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion. | A |
| 7 | Balance ball exerciser | Intended to be used as an unstable surface on which to perform exercise to improve balance and posture. | A |
| 8 | Balance-training tongue electrical stimulation system | Intended to provide biofeedback for training of balance by sensing body movements and subsequently producing signals which are translated into electrical stimuli applied to the tongue, enabling a patient to correlate electrotactile stimulation with their head and body position during exercise sessions. | B |
| 9 | Bed/chair electric massager | Intended to provide therapeutic massage to the occupant of a bed or chair for the treatment of body aches and pains. | B |
| 10 | Bicycle ergometer | Intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions. | A |
| 11 | Bladder-emptying vibratory stimulator | Intended to initiate urination and facilitate complete bladder emptying through application of small mechanical vibrations to the lower abdomen to promote urethral sphincter relaxation. | B |
| 12 | Blue/red/infrared phototherapy lamp | Intended to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasm, stiffness). | A |
| 13 | Body elastic exerciser | Intended to primarily strengthen several or all of the major muscle groups of the body (i.e., in the arms, legs, chest, back, and/orabdomen) through repetitive body motion against elastic resistance. | A |
| 14 | Body flywheel exerciser | Intended to strengthen several of the major muscle groups of the body (i.e., in the arms, legs, chest, back) through repetitive body motion against a flywheel. | A |
| 15 | Circulating-fluid thermal therapy system | Intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). | B |
| 16 | Cold compression therapy cervical spine collar | Intended to facilitate, through cooling and compression, the treatment of a variety of conditions resulting from injury/surgery to the neck region (e.g., inflammation,stiffness, whiplash). | A |
| 17 | Cold/cool therapy gel | Intended for localized topical skin application to provide a cooling effect for underlying muscles/joints to reduce pain and swelling. | A |
| 18 | Cold-air therapy unit | Intended to reduce localized pain/inflammation, and/or to reduce thermal skin damage by applying cold streams of air during dermatological laser treatments. | B |
| 19 | Core-body mechanical weight exerciser | Intended to enable a patient with a lumbar spine injury to perform controlled extension, contraction, and/or twisting movements of the lumbar/thoracic spine back region and the abdomen, for testing and rehabilitation. | A |
| 20 | Deep-tissue electromagnetic stimulation system | Intended to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders (e.g., osteoarthritis, osteoporosis); 2) treat body pain (musculoskeletal, postsurgical); and/or 3) help facilitate soft and hard tissue wound/injury healing, with no production of a therapeutic deep heat. | B |
| 21 | Electric massager | Intended for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility. | B |
| 22 | Electromechanical orthopaedic extracorporeal shock wave therapy system | Intended to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. | C |
| 23 | Electronic goniometer/kinesiology sensor | Intended to evaluate a patient’s range of motion/movement of individual joints/limbs/spine; it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess degree of physical fitness. | B |
| 24 | Exothermic heat therapy pack | Intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain. | A |
| 25 | Finger/hand exerciser | Intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity or density. | A |
| 26 | Foot sensorimotor therapy mechanical neurostimulator | Intended to provide non-invasive peripheral neurostimulation to the feet for improving somatosensory integration, typically for reducing motor impairments and balance disturbances in patients with neurological or neurodegenerative disorders (e.g., Parkinson’s disease). | C |
| 27 | Gait analysis system | Intended to be used to study walking or running patterns. | A |
| 28 | Hand dynamometer/pinch meter, electronic | Electronic device intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. | B |
| 29 | Hand dynamometer/pinch meter, mechanical | Mechanical device intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. | A |
| 30 | Hydrotherapy treadmill | Powered device intended for use in partially immersed in water, e.g., in a hydrotherapy tank, to provide additional resistance to the treadmill walking exercise without increasing the impact and/or stress | A |
| 31 | Interferential electrical stimulation system | Intended to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies that cross-over/interfere, producing a beating frequency at thetreatment point. | C |
| 32 | Manual goniometer | Non powered device intended to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint. | A |
| 33 | Medium-wave diathermy treatment system | Intended to produce a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio- frequency (RF) bands of 0.5 MHz to 1 MHz | B |
| 34 | Microwave diathermy treatment system | Intended to produce a therapeutic heat 1 to 2 cm below the skin within specific volumes of the body through the transcutaneous transmission of high frequency electromagnetic (EM) energy, typically 2,450 megahertz (MHz) [microwave], to promote tissue healing and pain relief. | B |
| 35 | Musculoskeletal infrared phototherapy unit, | Intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. | B |
| 36 | Musculoskeletal intense therapeutic ultrasound system | Intended to produce and deliver intense therapeutic ultrasound (ITU) waves through the skin to create ablative lesions in subcutaneous soft tissues (e.g., muscles, tendons). | C |
| 37 | Musculoskeletal/ physical therapy laser | Intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low- level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, disorders of the joints and soft/connective tissues), improving blood circulation in the treated areas to facilitate healing, or for non- needle acupuncture. | C |
| 38 | Parallel bar exerciser, | Intended to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. | A |
| 39 | Physical therapy massager | Electrically powered device intended to provide therapeutic massage to a larger area than hand-held massaging devices. | B |
| 40 | Physical therapy paraffin wax bath | Intended to be filled with liquid paraffin wax for physical therapy. | B |
| 41 | Physical therapy steam bath | Intended to apply hot steam as a physical therapy to a patient. | B |
| 42 | Pulsed signal therapy system | Intended to regenerate damaged cartilage, particularly by stimulating the production of collagen types that are present in healthy cartilage. | C |
| 43 | Short-wave diathermy treatment system | Intended to provide a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio- frequency (RF) bands of 13 MHz to 27.12MHz | C |
| 44 | Standard treadmill, mechanical | Intended to facilitate in-place walking, jogging, or running to promote muscle redevelopment, to restore motion to joints, and to promote weight loss and cardiovascular fitness. | A |
| 45 | Standard treadmill, powered | Electrically powered units intended to facilitate in-place walking, jogging, or running to promote muscle redevelopment, to restore motion to joints, and to promote weight loss and cardiovascular fitness. | A |
| 46 | Telemetric diagnostic spirometer | It is a Battery powered portable device Intended to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)], and to transmit the pulmonary function data via a communication device to a healthcare professional(s) at a remote server. | B |
| 47 | Therapeutic nuclear magnetic resonance system | Intended to influence cellular metabolism using nuclear magnetic resonance (NMR) for the treatment of degenerate and pathological changes to the movement/support profiles of a patient’s body, in particular diseased skeletal joints, bones, and surrounding muscle tissue (e.g., cervical and lumbar spine, shoulders,elbows, hands, hips, knees, feet). | C |
| 48 | Wall bars | A device that is permanently fixed to the wall intended for training and rehabilitation to regain and/or improve body movement and balance and/or for strengthening the limbs and the trunk of the body. | A |
Conclusion
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