NMPA Releases Latest Medical Device Termination Review Notices

On September 10, 2026, China's National Medical Products Administration published its latest batch of Medical Device Termination of Registration Review Notice delivery information. A total of 8 products were terminated from the registration review process, spanning dental, cardiovascular intervention, orthopedics, ophthalmology, and IVD sectors.

Domestic and imported products were equally represented on the list. Four domestic submissions were terminated: an oral barrier membrane retention pin from Chongqing Xike Medical Devices, a balloon guide catheter from Zhuhai Shenping Medical, a resin cement from Wuhan Dingchen Technology, and a platelet-rich plasma preparation kit from Shandong Maihe Additive Manufacturing.

On the imported side, notable entries include the plasma radiofrequency vaporization system from DePuy Mitek (represented by Johnson & Johnson Shanghai), a sodium zirconium phosphate silver foam dressing from Coloplast A/S (represented by Coloplast China), a preloaded aspheric posterior chamber intraocular lens from HOYA Medical Singapore (represented by HOYA JMS Ningbo), and a transcatheter valve repair system from Edwards Lifesciences (represented by Edwards Shanghai).

It is worth noting that termination of registration review has evolved from isolated cases to a normalized regulatory practice in China. In most instances, these terminations stem from voluntary applicant withdrawals rather than the review center rejecting the product. Common causes include failure to pay fees within the prescribed deadline, missing the supplementary submission window, or strategic business decisions to withdraw during the review process.

For medical device companies planning to enter or expand in the Chinese market, staying informed on NMPA registration trends and regulatory cadence is essential for successful product approval.