Trifanz Attends Public Training Session on the New Edition of the “Quality Management Specifications for Medical Device Production”

On May 19, 2026, a public training session on the new edition of the “Quality Management Specifications for Medical Device Production” was held in Hangzhou, organized by the Zhejiang Provincial Drug Administration and co-hosted by the Zhejiang Medical Device Industry Association. More than ten representatives from Trifanz, including the Management Representative, Quality Department Manager, Production Department Manager, inspection and release personnel, and materials control and procurement staff, attended the training.

At the opening of the training, Ye Lin, Secretary-General of the Zhejiang Medical Device Industry Association, delivered a welcome address, extending a warm welcome to the guests and corporate representatives in attendance, and introduced the background of the event. Liu Xianming, Director of the Medical Device Division at the Zhejiang Provincial Drug Administration, attended the event and delivered remarks.

The morning session was led by Professor Wang Qizhi, a Second-Level Researcher at the Zhejiang Provincial Drug Inspection Center. As a co-author of the new GMP and a national-level inspector, Professor Wang provided an in-depth interpretation of core modules including the background and rationale for the revision, design and development, quality control, and product release. Starting with the revision’s background, he analyzed the key changes in design and development as well as quality control chapter by chapter. The afternoon session was led by two other instructors from the Provincial Drug Administration, focusing on practical chapters such as procurement, validation and verification, production management, and contract manufacturing. By combining the original text of the provisions with key inspection points, they helped enterprises accurately grasp the differences between the new and old versions.

During the training, representatives from three companies, including Terumo Medical Products (Hangzhou), shared their practical approaches to upgrading their systems in accordance with the new GMP, providing participating enterprises with concrete examples for reference.

On November 4, 2025, the National Medical Products Administration (NMPA) issued the new edition of the “Medical Device Production Quality Management Specifications” (Announcement No. 107), which will officially take effect on November 1, 2026. Revised from the 2014 version, the new edition incorporates new concepts such as full lifecycle management and risk management, and adds requirements for digital supervision, setting higher standards for the operation of quality management systems at medical device manufacturers.

Trifanz dispatched a team of over ten members from key departments—including management, production, quality, testing, and procurement—to attend the training. The aim was to promptly grasp the changes in the new regulations, align with the updated requirements in advance, and prepare for the subsequent revision of system documentation and quality management upgrades.

As a manufacturer of respiratory and anesthesia consumables that has obtained ISO 13485 certification and whose products are distributed across 80 countries and regions worldwide, Trifanz has always regarded quality compliance as the lifeline of the company. This training initiative represents a concrete step in the company’s ongoing efforts to refine its quality management system and fulfill its mission of “making every breath worthy of trust.”

With approximately five and a half months remaining before the new “Specifications” take effect, Trifanz will use this opportunity to systematically advance the internal system update. This will ensure a seamless transition when the new regulations are implemented, enabling the company to provide stable and reliable medical consumables to global customers through higher quality standards and stricter compliance requirements.