China just clarified its classification for brain-computer interfaces — and that’s a big deal for anyone eyeing this market. NMPA’s new guideline sorts BCI devices into concrete risk classes and ...

The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the classification of products under the Medical Device Regulation (MDR) and the In Vitro ...

In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device regulation (MDR).

FDA has finalized guidance on medical device classification product codes that are used to assist in accurate identification and tracking of current medical devices, and for easy reference to ...

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 ...

After enactment of the Medical Device Amendments of 1976, which established three regulatory classes for medical devices, the Food and Drug Administration (FDA) has been required to classify all ...

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 ...