DCGI classifies 60 medical devices related to rehabilitation
In order to regulate the safety, quality, and performance of medical devices, the Drug Controller General (India), Directorate General of Health Services, India's Central Medical Device Regulator, has issued a notification classifying medical devices pertaining to rehabilitation under the provisions of Medical Devices Rules,2017.
The Drug Controller General (India) has classified 60 medical devices related to rehabilitation like acupressure calf band, arthritis TENS system, back/leg/chest dynamometer, electronic, balance-training tongue electrical stimulation system, bicycle ergometer, bladder -emptying vibratory stimulator among others. The classification is primarily risk score with class A being low risk to class D which describes high risk.
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Risk classification DCGI classifies 60 medical devices related to rehabilitation
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