The Medical Devices Rules, 2017 were notified by the Ministry of Health and Welfare to put in place certain standards to regulate the use of medical devices and to ensure that medical devices meeting exacting standards of quality and safety were being employed in the healthcare industry. Medical devices which are to be manufactured need to be registered as per the Rules. The Rules state that the manufacturers of medical devices must obtain manufacturing permission based on the risk associated with the device. The Rules also mandate that manufacturers of medical devices who want to obtain loan licenses manufactured for sale or distribution need to apply to the concerned authority. The Rules make it mandatory for such manufacturers that require loan licenses to manufacture medical devices for sale or distribution to file applications in accordance with the Rules. Scroll down to check more about Form MD-4 and Form MD-6.<\/p>\n\n\n\n
The medical\ndevices are divided into four classes, namely, Class-A, Class-B, Class-C and\nClass-D, based on the risk element associated with them. Applications under\nForm MD-4 and Form MD-6 pertain to medical devices from Class-A contains minimal-risk\ndevices and Class-B contains devices which are considered to fall in the range\nof low to moderate-risk devices. Class- contains devices where the risk is\nmoderate to high, and Class-D contains high-risk devices.<\/p>\n\n\n\n
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