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 ...

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 ...

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 ...

In what would translate into streamlining and tightening of regulations of manufacture, sale and distribution of the $2.12-billion medical devices market, the category will get a separate definition ...