NMPA Suspends Import, Distribution and Use of HOYA Technosurgical's β-Tricalcium Phosphate for Surgical Implants Over Quality Deficiencies

On July 27, 2026, China's National Medical Products Administration (NMPA) issued a significant enforcement announcement (No. 69 of 2026) ordering the immediate suspension of import, distribution, and use of β-Tricalcium Phosphate for surgical implants manufactured by HOYA Technosurgical Corporation of Japan (registration certificate number: National Medical Device Import Registration No. 20163132525).

The NMPA conducted an on-site inspection of HOYA Technosurgical's manufacturing facilities and found that the company's quality management system exhibited critical deficiencies in two key areas: special process validation and product testing. These deficiencies were determined to pose product quality and safety risks, leading the inspection team to issue a comprehensive assessment conclusion that the facility "does not comply with China's Medical Device Production Quality Management Standards".

Citing the Medical Device Supervision and Administration Regulations and the Medical Device Production Supervision Measures, the NMPA determined that immediate regulatory action was necessary to protect public device safety. The suspension took effect immediately upon publication of the announcement.

This enforcement action underscores the NMPA's increasingly rigorous approach to foreign medical device manufacturers operating in the Chinese market. For companies seeking to maintain or obtain market access in China, this case serves as a critical reminder that regulatory compliance extends beyond initial registration to ongoing quality management system adherence. Manufacturers should ensure their special process validation protocols and product testing procedures meet Chinese GMP requirements, as the NMPA continues to strengthen its on-site inspection capabilities for both domestic and international manufacturers.