Regulatory Insights from Europe to the Greater Bay Area

May was a high-energy month for Cisema, with our CEO, director, and senior experts actively contributing to global regulatory events. From AI in healthcare to new approval pathways in China, here's what international stakeholders need to know.

RAPS Euro Convergence 2025 – Brussels

Cisema business development director Stephanie held a panel discussion in RAPS

Hamish King presented on China’s latest regulatory and clinical updates.
Stefanie Fasshauer led a session exploring EMA and FDA programs accelerating access for products addressing unmet medical needs.
We connected with global medtech and pharma professionals to discuss compliance strategies across Europe, China, and Southeast Asia.

A popular theme is the increasing role of AI throughout regulatory: in regulatory submissions and clinical R&D and beyond. Yes, it is a buzzword, but to what extent does it really signify a foundational shift in global innovation practices? This was a topic for which there are strongly different conclusions from different speakers.

On the final day, Hamish and Jacky Li dove into China's 2025 regulatory reforms and unique market access pathways via Hainan, Hong Kong, and the Greater Bay Area (GBA).

Asia Summit on Global Health (ASGH) – Hong Kong

At ASGH 2025, we joined conversations around global health innovation and investment. The summit featured policy updates on Hong Kong’s new health authority and its GBA Connect scheme, aimed at fast-tracking Hong Kong-approved products into mainland China’s GBA—an opportunity for companies eyeing access to a market of over 80 million people.

With thought leaders from government, academia, and investment communities, ASGH served as a bridge between cutting-edge innovation and commercial opportunity.

Hong Kong International Medical Device Regulatory Forum

HK International Medical Device Regulatory Forum

We participated in a forum co-organized by CUHK and Hong Kong’s Medical Device Division. The central theme was regulating innovation and AI in medical devices.

Adaptive regulatory models for AI-driven software and medical robotics.
The importance of clinical validation across diverse populations.
The upcoming Hong Kong medical device legislation, expected within two years.

Updates from Malaysia’s and Saudi Arabia’s authorities underscored the increasing value of regional regulatory collaboration in managing fast-evolving technologies.

GBA Medical Device Regulations and Approval Process Training

Cisema participated in the GBA Medical Device Regulations and Approval Process Training, organized by the Guangdong Medical Device Management Society. This highly focused seminar brought together regulatory professionals across the Greater Bay Area to unpack China’s evolving regulatory environment.

Over the course of three sessions, the training provided a deep dive into the National Medical Products Administration (NMPA) framework—covering everything from Class I to Class III classifications, expedited review pathways like the Innovation and Emergency channels, and post-market compliance strategies.

Whether you're seeking approval for a software-as-a-medical-device app, an active robotic surgical system, or a non-powered implant, this seminar provided step-by-step guidance for navigating China's increasingly digitized and standardized regulatory process—especially within the GBA’s streamlined cross-border environment.

Further Information

If you are a medtech company with questions about how long it takes or how much it costs to register your product for the China market, please contact Cisema.