CDSCO Medical Device Rules in India: Classification For Physical Support As Medical Device
CDSCO Physical Support Device Classification: India Guide
This article is about Physical Support Products Classification. Central Drugs Standard Control Organization (CDSCO) has developed risk based classification lists for these products to guarantee that they comply with international safety and effectiveness requirements. Through this classification, manufacturers can understand the risk and purpose of their devices. The CDSCO regulations for medical devices in India have been updated to encourage innovation while maintaining patients' safety and meeting international requirements.
India is Updating Existing Risk Based Classifications for Physical Support Products
According to the latest circular MED-16014(12)/1/2024-eoffice dated 6th January, 2025, 23 devices of this type have been downgraded from Class A to Class A (Self Notified). It will make compliance easier for low risk devices and is in line with the CDSCO medical device classification in India scheme. Here is the complete list of the devices along with their respective classification.
Table: Physical Support Products classification in India as per the updated medical device rules:
Below is the table that has the revised classification of the Physical Support. All devices that have been reclassified to Class A (Self Notified) have been shaded in dark grey. This information will assist manufacturers in navigating the process of 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) without patient 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/trauma to promote healing; some types may also operate with patient assistance under 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 device/motor assembly. | C |
12 | Physical therapy massager | Electrically powered devices 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) without assistance during continuous passive 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 orthopaedic deformities/injuries or to improve function of the ankle and/or foot; it may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and 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 the cervical 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 material intended 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 bodies 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 the healing 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, typically for the postsurgical treatment prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. | Class A Non Notified |
31 | Kinetic bed | Intended 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 tendon tightness 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 paper is in reference to notifications 29/Misc./03/2020-DC (150) and MED-16014(12)/1/2024-eoffice, concerning the gradual regulation of medical devices. The CDSCO medical device classification in India ensures that manufacturers remain compliant with the most recent guidelines issued in India. Manufacturers need to ensure compliance with the Medical Device Rules 2017 in India. Contact Morulaa for professional assistance regarding medical device registration in India. Morulaa provides an in house consultancy service for all your requirements related to these new regulations, please reach out to us at admin@morulaa.com.
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