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 Narendra Modi government has just removed a clause from India's foreign direct investment (FDI) policy to clear unintended obstacles which seemed to be delaying potential investments in several ...

"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 ...

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 ...

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 ...

India, which was the host of the Fourth edition of the ‘WHO Global Forum on Medical Devices’ at Visakhapatnam, is also witnessing a tirade against the quality of health-care equipment, with a special ...