The FDA is set to exempt certain types of software from regulatory oversight as it reconsiders its approach to products on the fringes of the medical device sector. Officials at the agency set out ...
"The new definition for medical devices will be aligned with that of the International Medical Device Regulators Forum and one which is globally accepted," an official said. Once the new definition is ...
The domestic medical devices industry in the country has suggested that the definition of manufacturer in the draft New Drugs, Medical Devices and Cosmetics (NDMDC) Bill, 2022, to be changed with more ...
In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of a medical ...
Industry urges Centre to change definition of manufacturers in Guidance Document for Medical Devices
In order to support indigenous medical device industry, the Association of Indian Medical Device Industry (AiMeD) has urged the Centre to change the definition of manufacturers in the Guidance ...
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