Jitendar Chauhan / 17th January, 2022

DCGI Enlists New Regulation For The Classification Of Medical Devices Pertaining Of Physical Support

Regulation/Guidelines

Medical Device,

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Summary:

The Drugs Controller General (India) has listed a new classification of medical devices pertaining to Physical Support based on the device’s intended use and risk and other parameters.

Drugs and Cosmetics Act, 1940, and Rules regulates all new medical device’s safety, quality, and performance. The Central Government has notified the new Medical Devices Rules, 2017 vide G.S.R. 78E dated January 31, 2017, to regulate the import, manufacture, clinical investigation, sale, and distribution of medical devices.

DCGI enlists new classification for Medical Devices pertaining to Physical Support

The Drugs Controller General (India) (DCGI), Directorate General of Health Services, has classified medical devices pertaining to Physical Support. DCGI implemented this classification on July 26, 2021.

Classification of medical device

Under the provisions of Medical Devices Rules, 2017, medical devices are classified into four risk classes, i.e., Risk Class A, B, C, and D. Tables 1, 2, and 3 lists all medical devices and their classification pertaining to Physical Support. The majority of the medical devices are listed under Risk class A whereas Risk Class C and D contain only one medical device each.

Risk class A

Ankle/foot orthosis

Balance board

Bed traction frame

Body arch traction table

Canalith repositioning procedure chair, manual

Cervical spine collar

Cervicothoracic spine orthosis

Cervicothoracolumbosacral spine orthosis

Collar and cuff arm sling material

Cranial orthosis

Elbow orthosis

Finger orthosis

Foot orthosis

Hand orthosis

Hand/finger splint

Horizontal non-powered traction system

Incentive spirometer

Kinetic bed

Knee immobilizer

Orthopaedic bed

Paediatric dorsiflexion slant board

Parapodium walking frame

Shoulder immobilizer

Swivel-walker

Toe separator

Wrist immobilizer

Table 1: List of Medical Devices included in Risk Class A.

Risk Class B

Ankle continuous passive motion exerciser

Chest-oscillation airway secretion clearing system

Flotation therapy bed, adult

Flotation therapy bed, neonatal

Hand/wrist continuous passive motion exerciser

Hip/knee continuous passive motion exerciser

Intermittent traction system

Physical therapy massager

Shoulder continuous passive motion exerciser

Traction table, line-powered

Table 2: List of Medical Devices included in Risk Class B.

Risk Class C	Risk Class D
Neuro-controlled ambulation exoskeleton	Cervical spine immobilization head ring

Table 3: List of Medical Devices included in Risk Class C and D.

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 medical devices pertaining to physical support based on the following factors:

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

The classification is subjected to changes

As per the provisions of Medical Devices Rules, 2017, the intended use for the medical devices is to guide the applicants during the import or manufacture of the medical devices. Additionally, the classification of medical devices pertaining to Physical Support can revise from time to time.

Summary:

The Drugs Controller General (India) has listed a new classification of medical devices pertaining to Physical Support from July 26, 2021.
The classification is based on the device’s intended use, risk, and other parameters listed in the First Schedule.
This classification can revise from time to time.