Trifanz Attends Hangzhou’s Second Public Training Session on Expanding Medical Device Sales Overseas

On July 3, 2026, the second session of the free training program on expanding into international markets for medical devices, organized by the Hangzhou Municipal Market Supervision Administration, was held at the National Artificial Intelligence Application Pilot Base. Representatives from Trifanz’s Foreign Trade Department attended the training and systematically studied key topics related to expanding into international markets, including EU MDR compliance strategies, market access in Southeast Asia, MFDS registration in South Korea, and the ISO 13485 quality management system.

This training program is a key initiative by Hangzhou to implement the requirements for building the “296X” advanced manufacturing cluster and to consolidate and enhance the international competitiveness of the medical device industry. It is primarily aimed at medical device registrants and filers in Hangzhou with export needs, and is designed to address enterprises’ growing demand for access to overseas markets. Co-organized by Ruixu Group, Applus+ Group, Hangzhou 296X Industrial Development, Yijian Chuhai, and Hangzhou Sizhen Technology, the training brought together technical expertise from multiple professional institutions.

This training program focuses on the four core areas currently receiving the most attention in the global expansion of medical devices. It systematically covers EU MDR compliance strategies (including technical documentation preparation, clinical data collection, and post-market surveillance), market access in Southeast Asia (analysis of regulations in key markets such as Singapore, Malaysia, and Thailand), MFDS medical device registration in South Korea (registration process, technical documentation requirements, and compliance risks), and the ISO 13485 Quality Management System (system establishment, key points for internal audits, and continuous improvement). Ranging from regulatory frameworks to real-world case studies, the training provides systematic compliance guidance for companies expanding into international markets.

As a manufacturer of respiratory and anesthesia consumables with products distributed in more than 80 countries and regions worldwide, Trifanz has always regarded its global compliance capabilities as one of its core competitive advantages. The company has obtained ISO 13485 certification, and several of its core products have received registration and certification from more than ten countries and regions, including the EU’s CE MDR and the U.S. FDA, giving it extensive practical experience in gaining access to overseas markets.

Participating in this public-interest training program on global market expansion, organized by the Hangzhou Market Regulation Bureau, is part of Trifanz’s ongoing efforts to continuously enhance its global compliance standards. From the European Union to Southeast Asia, and from quality management systems to country-specific registration practices, the company’s team consistently stays abreast of developments in international medical device regulations, prioritizing compliance to ensure the successful global expansion of its products and leveraging its professional expertise to serve customers worldwide.