Date: 4 September, 2026
Location: Shanghai New International Expo Centre (SNIEC), China
Introduction:
Currently, China's medical device industry is undergoing a profound transformation from scale growth to high-quality development. Against the dual backdrop of the accelerated "import-to-domestic production" shift and the continuously rising "overseas expansion strategy," medical device enterprises face unprecedented challenges and opportunities in compliance management across the upstream and downstream industrial chains.
As of the end of 2025, the bonded area has gathered over 200 medical device-related enterprises, with more than 60 of the world's top 100 medical device companies having established a presence there, and the annual import value of medical instruments and equipment accounts for nearly half of the national total. Meanwhile, the Shanghai Eastern Hub International Business Cooperation Zone (IBCZ), as a national-level strategic platform, has inaugurated the "A3 International Medical Technology Innovation Exchange Center." This special national strategic region is providing new policy space and functional carriers for the development of the medical device industry.
This conference, hosted by the Shanghai Pudong Medical Device Trade Association (MDTA) and combined with the Medtec China 2026 exhibition platform, seeks to build an industry exchange platform at the regulatory level, helping enterprises grasp policy trends, mitigate compliance risks, and connect with strategic resources. The event delves into two core topics:
1. Regulatory compliance for medical device overseas expansion.
There will be multiple sessions covering crucial questions such as: what are regulatory considerations for Chinese medical device manufacturers? What are the requirements for overseas AI/ML/PCCP regulations on Cdx products? And what is the essence of regulatory due diligence?
2. The localization of imported products.
There will be multiple sessions, for example diving into the opportunities and challenges of UDI in medical insurance settlement, or post-market surveillance systems and full lifecycle management of medical devices, accompanied by discussions on the implementation of the new edition of the China GMP.
Qserve is invited to attend the event, where Gert Bos will present during the global expansion morning sessions.
Session Details.
September 4 | 10:40-11:10
Topic: The Essence of Regulatory Due Diligence