Trifanz Attends On-site Training on the Revised

In November 2025, the National Medical Products Administration (NMPA) released the new version of the *Good Manufacturing Practice for Medical Devices*, which is set to take effect on November 1, 2026. Compared to the 2014 version, the new regulation comprises 15 chapters and 132 articles; it introduces provisions for quality assurance, verification and validation, contract manufacturing, and digital/smart regulation. By incorporating concepts of full lifecycle management and risk management, it establishes stricter compliance standards for medical device manufacturers regarding system operations, process control, and product traceability.

To ensure a smooth transition between the old and new systems and align with upcoming regulations, Chuanfangzhi organized an in-person training session on the new standards for key personnel across production, quality, and material control departments, laying the groundwork for the system upgrade and internal process optimization.

Led by an authoritative industry expert, the training was highly practical in nature. The instructor broke down the complex new regulatory framework into 200 specific on-site inspection items, clearly distinguishing risk levels for various clauses and defining precise compliance verification standards. The course focused on frequently inspected areas—such as design and development, quality control, product release, electronic data traceability, and material management—and highlighted the differences between the old and new standards through real-world inspection case studies.

Drawing on the specific production characteristics of the respiratory and anesthesia consumables industry and real-world export scenarios, the training participants conducted a detailed, item-by-item self-assessment against the new regulations. They identified areas for improvement across key modules—such as production control, warehousing management, quality traceability, and risk prevention—and devised actionable implementation plans. Moving beyond superficial learning, the team is committed to integrating compliance requirements directly into actual production and operations.

Compliance is the fundamental cornerstone for medical device companies expanding into international markets. As a specialized manufacturer of respiratory and anesthesia consumables, Chuanfangzhi holds ISO 13485 international quality system certification and supplies products to numerous countries and regions worldwide. Moving forward, the company will steadily advance quality system upgrades, document revisions, and process optimizations to ensure a seamless transition to the new regulations. Through rigorous compliance management, Chuanfangzhi upholds its brand philosophy of "Global Compliance, A Trusted Partner," continuing to provide stable and reliable medical consumables to customers around the globe.

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