Recently, DCGI (Drug Controller General of India)[1] issued a notice regarding the classification of Rehabilitation Medical Devices under the Provisions of the Medical Device Rules, 2017. The decision comes as the latest in the Drug Regulator’s (DCGI) efforts to classify the medical devices sold in the nation based on the perceived risks of the product type & its use in patients. This measure is to aid the Authority in bringing all the medical devices under Regulatory Control. In July 2022, the Drug Controller General of India classified medical devices pertaining to rehabilitation and some of the same devices are mentioned in the new notice issued on 04 Aug, 2022. Scroll down to check the classification of Rehabilitation Medical Devices under the Medical Device Rules, 2017.
What is Rehabilitation?
It is the process of regaining strength or relearning skills after a serious injury, surgery, or illness. Rehabilitation crosses all age groups, though the type, level and goals of rehabilitation will differ depending on the individual needs. Rehabilitation often focuses on:
- Occupational therapy to help with daily activities;
- Treatment of pain;
- Physical therapy to help with mobility, fitness, and strength;
- Cognitive therapy (following head injury);
- Speech-language therapy to help with understanding, writing, reading, and swallowing.
Different Classes of Indian Medical Devices
In India, medical devices are categorised into 4 different classes based on the extent of risk associated with these medical devices. Below is the table of 4 different categories of Medical Devices in India:
| Device Class | Risk |
| Class A | Low-Risk |
| Class B | Low Moderate Risk |
| Class C | Moderate-High Risk |
| Class D | High Risk |
New Classification of Rehabilitation Medical Devices
The DCGI has released the updated classification of rehabilitation medical devices under the Medical Device Rules, 2017 and you can check the same below:
| Class A | Class B | Class C | Class D |
| Acupressure calf bandBack or leg or chest mechanical dynamometerBicycle ergometerBlue or red or infrared phototherapy lampCold compression therapy cervical spine collarCold or cool therapy gelCore-body mechanical weight exerciserExothermic heat therapy packGait analysis systemMechanical hand dynamometer or pinch meterHydrotherapy treadmillManual goniometerParallel bar exerciserSilicone prosthetic earSilicone prosthetic noseExternal assembled lower limb prosthesisExternal limb prosthesis socket linerFinger or thump prosthesisTruncatal orthosisProsthesis external armCongenital hip dislocation abduction splintDenis brown splintArm slingCrutchesAbdominal support | Arthritis TENS systemBack or leg or chest electronic dynamometerBalance-training tongue electrical stimulation systemBed or chair or electric massagerBladder-emptying vibratory stimulatorCirculating-fluid thermal therapy systemCold-air therapy unitDeep-tissue electromagnetic stimulation systemElectronic goniometer/kinesiology sensorElectric hand dynamometer or pinch meterMedium-wave diathermy treatment system, Microwave diathermy treatment systemMusculoskeletal infrared phototherapy unitPhysical therapy massagerPhysical therapy paraffin wax bathPhysical therapy steam bathTelemetry diagnostic spirometerUpper extremity prosthesis consisting of a simultaneously powered elbow and/or shoulder with greater than 2 simultaneous powered degrees of freedom & controlled by non-implanted electrical components. | Electromechanical orthopaedic extracorporeal shock wave therapy systemFoot sensorimotor therapy mechanical neurostimulatorInterferential electrical stimulation systemMusculoskeletal intense therapeutic ultrasound systemMusculoskeletal or physical therapy laserPulsed signal therapy systemA short-wave diathermy treatment systemTherapeutic nuclear magnetic resonance system. | None among the 60 devices were categorised as Class D of the Regulation. |
Conclusion
The DCGI issued a notice regarding the classification of rehabilitation medical devices under the provisions of MDR, 2017 and these devices are classified with respect to their intended use, the risk associated with the device & other parameters specified in the 1st Schedule into Classes A and B.
Read our Article:When is Import of Medical Devices for Personal Use Allowed?
