NMPA's new BCI classification rules set device risk classes, a first regulatory gate for foreign investors in China neurotech.

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).

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 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 ...

Centre proposes expedited licensing for medical device manufacturing to enhance efficiency, transparency, and timely access ...

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 ...

Draft amendments to the Medical Device Rules seek to reduce manufacturing licence timelines for Class B, C and D devices to ...

The Union health ministry is proposing to significantly cut down the time taken to issue manufacturing licenses for medical ...