The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the ...

FDA's Center for Devices and Radiological Health (CDRH) issued a request for public comment on December 5, 2025, seeking feedback on the distinct classification of existing medical device accessories ...

The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday ...

Connected medical devices can improve patient care and operational efficiency. However, they also introduce new privacy and security risks. Healthcare providers should rethink their privacy and ...

A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...

The FDA is excluding eight software functions that were previously classified as medical device status under the 21st Century Cures Act. The FDA released the new provisions in an April 19 document in ...