New China quality control standards affect scores of medical devices

A new set of legal mandates and recommendations released by China’s National Medical Products Administration are designed to bring the quality of scores of medical devices, including in vitro devices, manufactured in China into accordance with international norms. The 2020 Medical Device Industry Standards Revision Plan issued on March 20 outlines a series of recommendations by regulatory authorities on manufacturing methods, performance testing standards, biological evaluation, non-clinical standards and quality systems of 86 medical devices and IVDs.

They include nine mandatory standard requirements on the safety and performance of breast implants and other surgical implants, liver radiofrequency ablation treatment equipment, respiratory support equipment, and ophthalmic optics devices.

In addition, 77 recommended standards address the quality and evaluation of a range of devices, including artificial intelligence medical devices and medical additives.