Medical devices that pose the highest risk to patients’ health would face stricter clinical trial mandates in China under regulations newly drafted by China’s National Medical Products Administration (NMPA).
The draft regulations affect Class III medical devices with life support to sustenance functions. Designed to provide legal safeguards for doctors and patients and improve safety, they are part of a broad reworking of medical device industry standards launched by China over the past two years.
The regulations would require clinical trials in China on implantable cardiac rhythm management equipment, ventricular assist systems, and drug infusion devices. Also included in the list of medical devices requiring clinical trials in China are artificial heart valves and intravascular stents, tissue engineering medical products containing living cells, etc.