Medical Device Amendments for Devices Used in Physical Support

CDSCO Medical Device Registration: Amendments for Devices Used in Physical Support

This article covers recent CDSCO medical device registration amendments related to the intended use of medical devices in the physical support category. The Central Drugs Standard Control Organization (CDSCO) is India’s regulatory authority overseeing pharmaceuticals and medical device regulations. All notified medical products, including physical support devices, fall under CDSCO’s jurisdiction.

The Drugs Controller General of India (DCGI), under CDSCO, is responsible for product approvals, ensuring compliance with the CDSCO registration process for medical devices. CDSCO regulates drugs, cosmetics, in-vitro diagnostics (IVDs), and medical devices, along with quality control of imported devices. Manufacturers looking to enter the Indian market can leverage approvals from the US, Canada, Europe, Australia, or Japan to streamline their CDSCO medical device registration process.

The Drugs and Cosmetics Act, 1940 governs medical device regulations in India, covering importation, manufacturing, and distribution of medical devices. This Act enforces must to follow quality standards to ensure that all imported medical devices meet safety and efficacy requirements. – Click Here

CDSCO Registration Process: Amendment on Intended Use of Physical Support Devices

With continuous regulatory updates, CDSCO has recently modified the intended use classification of various medical devices under Appendix A. This classification is based on:

Intended Use
Risk Factors
Regulatory Parameters

While CDSCO provides a general intended use, manufacturers can specify a device’s specific intended use based on its function. Since this classification is dynamic, manufacturers must stay updated on the latest CDSCO medical device registration requirements to ensure compliance.

Below is the CDSCO-approved classification table for medical devices used in physical support, detailing their intended use and regulatory category.

India Updates Risk-Based Classifications for Physical Support Medical Devices

As per the latest notification MED-16014(12)/1/2024-eOffice, released on January 6, 2025, several physical support medical devices have undergone risk-based reclassification. One device has been reclassified from Class A to Class B, another device has been reclassified from Class B to Class A, and 23 devices have been reclassified from Class A to Class A (Self-Notified). This update aligns with CDSCO’s medical device regulations, ensuring better compliance and a streamlined approval process in India. The update impacts the CDSCO Medical Device Approval Process, enabling efficient handling of devices based on their risk classification. The full list of medical device amendments for physical support products, along with their updated classifications, is available in this document, with changes clearly highlighted for reference.

Table: CDSCO Physical Support Device Classes and Risk Classification

S.No.	Device Name as per Medical Device Rules in India	Intended Use	Risk Class
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	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
5	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
6	Hand/wrist continuous passive motion exerciser	Hand/wrist continuous passive motion exerciser	B
7	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
8	Intermittent traction system	It is an AC powered electronic device. Intended to apply and relieve pre-set traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae.	B
9	Knee immobilizer	Intended to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy.	A
10	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
11	Physical therapy massager	Electrically powered device intended to provide therapeutic massage to a larger area than hand-held massaging devices.	B
12	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 patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joint.	B
13	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
14	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
15	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
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 (Self-Notified)
17	Balance board	Intended to train patients with difficulties in balance (e.g., a paraplegic or a stroke victim) walks for balance training.	Class A (Self-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 (Self-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 (Self-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 (Self-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 (Self-Notified)
22	Cervicothoracic spine orthosis	Intended to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine.	Class A (Self-Notified)
23	Cervicothoracolumbosacral spine orthosis	Intended to encompass the cervicothoracolumbosacral spine region of the neck and trunk.	Class A (Self-Notified)
24	Collar and cuff arm sling material	Fabric and form composite material intended to immobilize forearm, elbow, humerus or shoulder injuries.	Class A (Self-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 (Self-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 (Self-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 (Self-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 (Self-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 (Self-Notified)
30	Incentive spirometer	Intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing.	Class A (Self-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 (Self-Notified)
32	Orthopaedic bed	Intended to provide support for skeletal traction to stabilize fracture sites.	Class A (Self-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 (Self-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 (Self-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 (Self-Notified)
36	Swivel-walker	Intended to encompasses 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 (Self-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 (Self-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 (Self-Notified)

Conclusion

Navigating the CDSCO registration process can be complex, but Morulaa is here to assist you. Our regulatory consultancy services provide expert guidance on medical device regulations in India, ensuring a smooth CDSCO medical device registration process.