New Delhi : The Drug Controller General (India) has classified medical devices including personal protective equipment, devices in general hospitals and those pertaining to nephrology and renal care, pain management, operation theatre and certain softwares.
In the personal protective equipment, the drug regulator has classified 32 devices, including latex surgical glove, face shield, protective garment for incontinence, radiation protection gloves and apron, latex medical examination glove, surgical gown and cap among others.
A total of 57 devices pertaining to general hospitals, including bed exit monitor, fall prevention, spinal fluid manometer, stand on patient scale, sterilisation process indicator – both biological and physical/chemical, manual adjustable hospital bed, medical insole, remote medication management system, and others were classified in a separate order.
In the nephrology and renal care segments, it has classified 44 medical devices, including automated peritoneal dialysis system, dialysed connector, disposable hemoperfusion cartridge, kidney stone filter, among others.
In pain management, the regulator has classified 28 devices including ice collar, ice bag, foot bath, heat therapy gel, ear micro system needle, bite relief pad, and others.
Sixty software’s including ventilator software, continuous glucose monitor retrospective data analysis software, insulin pump secondary display, coronary vascular physiologic simulation software, electrocardiograph software for home use, etc. are also classified by the drug regulator through a notice now.
Twenty six devices pertaining to operation theatres including operation table system, surgical robot unit, high-flow blood transfusion pump, hemostatic knife, surgical light system and others have also been classified as medical devices under the Drugs and Cosmetics Act, 1940.
Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and the rules. For the regulation of medical devices with respect to the import, manufacture, clinical investigation, sale and distribution, the central government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices Rules, 2017 through a notification on January 31, 2017, which commenced from January 1, 2018.
The DCGI said that the general intended use of each of the devices mentioned in the notices classifying these devices under the Act, is for guidance to the applicants intended to furnish application of import or manufacture of medical devices under the provisions of the Rules. However, a device may have specific intended use as specified by the manufacturer.