NMPA Issues Announcement on Cancellation of 11 Medical Device Registration Certificates

On September 23, 2026, China's National Medical Products Administration published Announcement No. 95 of 2026 regarding the cancellation of 11 medical device registration certificates, including guide wires. In accordance with the Regulations on the Supervision and Administration of Medical Devices, and upon application by the respective companies, the NMPA cancelled the registration certificates of 11 products from 5 companies.

The cancellations involve both domestic and international manufacturers. William A. Cook Australia, Pty. Ltd. had the highest number of cancellations — 7 products in total, all in the assisted reproductive technology (ART) field, including the COOK Sydney IVF PVP sperm immobilization medium, Sperm Gradient Kit, Spermient, Blastocyst Vitrification Kit, Blastocyst Warming Kit, and Sperm Medium, as well as one Nathanson Liver Retraction System. Shenzhen Cooper Medical Co., Ltd. cancelled one guide wire product (Domestic Medical Device Registration No.20233030018). Adentatec GmbH cancelled one dental alloy for porcelain on nickel-chrome base. Yuanda Keynuit Medical Technology (Changzhou) Co., Ltd. cancelled one paclitaxel-releasing coronary balloon dilatation catheter (Domestic Medical Device Registration No.20253032042). Anhui Taikang Medical Technology Co., Ltd. cancelled one locking metal bone screw (Domestic Medical Device Registration No.20253130386).

It is worth noting that all of these cancellations were voluntary applications submitted by the companies, representing a normal part of the medical device registration certificate lifecycle management. The product categories involved span interventional devices, ART products, dental restorative materials, and orthopedic implants, reflecting companies' proactive approaches to portfolio optimization and registration strategy adjustments.

From an industry perspective, the cancellation of registration certificates does not equate to product withdrawal or quality safety issues. Rather, it represents a routine operation in which companies adjust market strategies, iterate products, or reallocate registration resources. Keeping abreast of regulatory developments helps industry stakeholders better navigate compliance trends and market dynamics.