On May 19, 2026, a public training session on the updated Medical Device Production Quality Management Specifications was held in Hangzhou. The event was organized by the Zhejiang Provincial Drug Administration and co-hosted by the Zhejiang Medical Device Industry Association. Trifanz sent more than ten representatives from departments including management, quality, production, inspection, release, procurement, and materials control to attend the training.
At the beginning of the session, Ye Lin, Secretary-General of the Zhejiang Medical Device Industry Association, delivered a welcome speech and introduced the background and purpose of the event. Liu Xianming, Director of the Medical Device Division of the Zhejiang Provincial Drug Administration, also attended and addressed the participants.
The morning session was presented by Professor Wang Qizhi from the Zhejiang Provincial Drug Inspection Center. As one of the contributors to the revised GMP and a national inspector, Professor Wang explained the key updates in areas such as revision background, design and development, quality control, and product release. In the afternoon, instructors from the Provincial Drug Administration focused on topics including procurement, validation and verification, production management, and contract manufacturing, helping companies better understand the differences between the old and new regulations.
During the training, representatives from several companies, including Terumo Medical Products (Hangzhou), shared their experiences in upgrading quality systems based on the new GMP requirements, offering useful practical references for participating enterprises.
On November 4, 2025, the National Medical Products Administration (NMPA) officially released the updated Medical Device Production Quality Management Specifications (Announcement No. 107), which will take effect on November 1, 2026. Compared with the 2014 version, the revised regulations introduce concepts such as lifecycle management, risk management, and digital supervision, while also placing higher requirements on medical device quality management systems.
Through this training, Trifanz aimed to gain a timely understanding of the latest regulatory updates and prepare in advance for future system documentation revisions and quality management improvements.
As a manufacturer of respiratory and anesthesia consumables with ISO 13485 certification and products distributed in over 80 countries and regions, Trifanz continues to regard quality compliance as a core priority. The company will use this opportunity to further improve its internal quality management system and ensure smooth compliance with the new regulations while continuing to provide reliable medical consumables to customers worldwide.