Indian risk-based regulatory standards for medical-grade physical support equipment
CDSCO Medical Device Rules In India: Classification For Physical Support As Medical Device
This article focuses on the classification of Physical Support Products. The Central Drugs Standard Control Organization (CDSCO) has established risk-based classification lists to ensure these devices meet international safety and efficacy standards. This classification helps manufacturers understand the risk level and intended use of their devices. The updated CDSCO medical device rules in India support innovation while ensuring patient safety and compliance with global standards.
India is Updating Existing Risk-Based Classifications for Physical Support Products
As per the latest notification MED-16014(12)/1/2024-eoffice released on January 6th, 2025, 23 devices in this category have been reclassified from Class A to Class A (Self Notified). This change simplifies compliance for low-risk devices and aligns with the CDSCO medical device classification in India framework. You can view the full list of devices and their updated classifications in this document.
Table: Physical Support Products classification in India as per the updated medical device rules:
The table below provides the updated classifications for Physical Support. Devices reclassified to Class A (Self Notified) have been highlighted in dark grey for better identification. This detailed breakdown helps manufacturers and stakeholders navigate the medical device registration in India
S.No | Name of the Medical Device as per Medical Device Rules 2017 | Intended use | Classification |
1 | Ankle continuous passive motion exerciser | Electrical devices intended to continuously move the ankle joint (e.g.,flexion, inversion/eversion) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joint. | B |
2 | Cervical spine immobilization head ring | Intended to be fixed to the skull of a patient at brow level using pointed,steel, threaded bolts (typically four)that are adjusted to penetrate the outer bone of the skull. | D |
3 | Chest-oscillation airway secretion clearing system | Intended to rapidly inflate and deflate against the chest wall of the patient for promoting airway clearance by creating high frequency chest wall oscillation (HFCWO), resulting in the mobilization of bronchial secretions. | B |
4 | Finger orthosis | Intended to encompass the whole or part of the finger to support, align,prevent, or correct deformities/injuries or to improve function of the finger. | A |
5 | Foot orthosis | Intended to encompass the whole or part of the foot, or designed as a plantar insert, and intended to provide rigid or semi-rigid correction of the foot for persons with orthopaedic deformities/injuries of the feet | A |
6 | Hand orthosis | Intended to encompass the whole or part of the hand to support, align,prevent, or correct deformities/injuries or to improve function of the hand. | A |
7 | Hand/wrist continuous passive motion exerciser | A mains electricity (AC-powered)deviceIntended to continuously move the metacarpal/interphalangeal joints(e.g., flexion and extension) withoutpatient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joints. | B |
8 | Hip/knee continuous passive motion exerciser | A mains electricity (AC-powered)device Intended to provide continuous passive motion (CPM) exercise therapy for the hip and/or knee,typically following joint surgery/traumato promote healing; some types mayalso operate with patient assistanceunder controlled active motion (CAM). | B |
9 | Intermittent traction system | It is an AC powered electronic device.Intended to apply and relieve pre-settraction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. | B |
10 | Knee immobilizer | Intended to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy. | A |
11 | Neuro-controlled ambulation exoskeleton | Intended to assist a patient with a walking disability (neurogenic,muscular, or osseous in origin) regain lost motor function by transmission of the patient’s residual nerve function,via cutaneous electrodes, to the devicemotor assembly. | C |
12 | Physical therapy massager | Electrically powered device intended to provide therapeutic massage to a larger area than hand-held massaging devices. | B |
13 | Shoulder continuous passive motion exerciser | It is a mains electricity (AC-powered)device Intended to continuously move the shoulder joint (e.g., flexion,rotation, adduction/abduction) withoutpatient assistance during continuouspassive motion (CPM) exercise therapy usually following surgery or trauma to the joint. | B |
14 | Traction table, line- powered | Intended to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a motorized mechanical manipulation of the spine. | B |
15 | Cranial orthosis | Intended to be worn on the head of an infant with an abnormal head shape(e.g., due to plagiocephaly,brachycephaly, scaphocephaly), or after craniosynostosis repair surgery,to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. | B |
16 | Ankle/foot orthosis | Intended to encompass the ankle joint,or the ankle and foot, to support, align,prevent, or correct orthopaedicdeformities/injuries or to improvefunction of the ankle and/or foot; it mayalso be intended to offload andredistribute foot pressures that affectpedal circulation to improve blood flowand help heal diabetic foot ulcers or post surgical wounds. | Class A Non-Notified |
17 | Balance board | Intended to train patients with difficulties in balance (e.g., a paraplegic or stroke victim) walks for balance training. | Class A Non-Notified |
18 | Bed traction frame | Intended to treat patients with fractures and other orthopaedic disorders (e.g.,of the lower or cervical spine, hip). | Class A Non-Notified |
19 | Body arch traction table | Intended to support the body of a patient and provide traction for the back muscles and spine by flexing the patient into a reverse supine body/arch. | Class A Non-Notified |
20 | Canalith repositioning procedure chair, manual | Intended to treat balance disorders[e.g., benign paroxysmal positional vertigo (BPPV), canalithiasis] caused by displaced canaliths (otoconia) in the inner ear of the patient | Class A Non-Notified |
21 | Cervical spine collar | Intended to support or immobilize thecervical spine to treat deformities,fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). | Class A Non-Notified |
22 | Cervicothoracic spine orthosis | Intended to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine. | Class A Non-Notified |
23 | Cervicothoracolumbosacral spine orthosis | Intended to encompass the cervicothoracolumbosacral spineregion of the neck and trunk. | Class A Non-Notified |
24 | Collar and cuff arm sling material | Fabric and form composite materialintended to immobilize forearm, elbow,humerus or shoulder injuries. | Class A Non-Notified |
25 | Elbow orthosis | Intended to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. | Class A Non-Notified |
26 | Flotation therapy bed, adult | Intended to minimize pressure points on a patient’s body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g.,water, air, or mud that lifts the patient to simulate a floating effect. | Class A Non-Notified |
27 | Flotation therapy bed, neonatal | Intended to minimize pressure points on neonatal patient’s body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect. | Class A Non-Notified |
28 | Hand/finger splint | Intended to immobilize an injured hand to protect injuries to, e.g., the digits,metacarpals, and wrist during thehealing process. | Class A Non-Notified |
29 | Horizontal non-powered traction system | Non powered device intended to be attached to a table for the application of constant horizontal traction forces to the cervical or lumbar vertebrae by means of attached harnesses whilst the patient typically lies in a supine position on the table during treatment. | Class A Non-Notified |
30 | Incentive spirometer | Intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typicallyfor the postsurgical treatment andprevention of atelectasis (lungcollapse) and to help facilitate airwayopening and clearing. | Class A Non-Notified |
31 | Kinetic bed | Intend to enable continuous change of the patient’s lying position, e.g., it can tilt the entire bed mattress support system (this includes the mattress, the framework that supports the mattress,and the bedding) lengthways,sideways or to a near vertical tilt. | Class A Non-Notified |
32 | Orthopaedic bed | Intended to provide support for skeletal traction to stabilize fracture sites. | Class A Non-Notified |
33 | Paediatric dorsiflexion slant board | Intended to be used in the treatment of various medical conditions (e.g.,congenital, neurological, post-traumatic) in paediatrics, where tendontightness and muscle contracture affect the ability to dorsiflex the foot,possibly leading to an abnormal gait | Class A Non-Notified |
34 | Parapodium walking frame | Intended to encompass and provide support for the body of a patient who is unable to stand unassisted to help them move (walk) by changing their centre of gravity (COG). | Class A Non-Notified |
35 | Shoulder immobilizer | Intended to temporarily immobilize or limit abduction of the shoulder joint to support healing of an injury or a surgical wound. | Class A Non-Notified |
36 | Swivel-walker | Intended to encompass and provide support for the body of a patient who is unable to stand unassisted, to help them move (walk) by rocking sideways(shifting their weight from side-to-side with a shoulder movement) which makes the footplate of the device swivel so that it “walks” forward. | Class A Non-Notified |
37 | Toe separator | Intended to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural position. | Class A Non-Notified |
38 | Wrist immobilizer | Intended to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains,and muscle injuries of the wrist. | Class A Non-Notified |
Conclusion: Physical Support Products Registration for Medical Device Compliance in India:
This article is based on notifications 29/Misc./03/2020-DC (150) and MED-16014(12)/1/2024-eoffice, outlining the phased regulation of medical devices. The CDSCO medical device classification in India helps manufacturers stay compliant as per the latest regulations in India. For similar technical frameworks, you can also find the related risk classification for Rehabilitation and Pain Management here.
Manufacturers must adhere to the Medical Device Rules 2017 in India. For expert guidance on medical device registration in India, contact Morulaa. Our in-house consultancy team offers end-to-end solutions to navigate these regulatory updates efficiently, email us at [email protected] or visit our website for the latest updates.
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