Regulation/Guidelines

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

  • 17th January, 2022

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 CRisk Class D
Neuro-controlled ambulation exoskeletonCervical 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:

  1. Intended use.
  2. Risk factors.
  3. 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.

References

  1. Classification of Medical Devices pertaining to Physical support under the provisions of Medical Devices Rules, 2017-Reg. Accessed on Aug 8, 2021