The Directorate General of Health Services, Drugs Controller General (India), on 4th August, 2022, issued a notice regarding classification of medical devices pertaining to Rehabilitation under the provisions of Medical Devices Rules, 2017. The devices are classified with respect to their intended use, risk associated with the device and other parameters specified in First Schedule, into Classes A and B.
Schedule I of the Medical Device Rules, 2017 covers a comprehensive list of medical devices categorised into the following classes:(i) low risk – Class A; (ii) low moderate risk- Class B; (iii) moderate high risk- Class C; (iv) high risk- Class D.
Directorate General of Health Services, Drugs Controller General (India) has now by virtue of the present notice, inserted Appendix A in Schedule I. This Appendix lists 60 medical devices pertaining to rehabilitation which have now been brought within the ambit of the Medical Device Rules, 2017. The Drug Controller has also thereby categorized the said 60 devices into the above stated four categories so as to facilitate importers and manufacturers of these devices in their licensing applications.
