InvestHK hosted a seminar on September 9, 2024, “Hong Kong as Asia’s Medical Technology Hub: Navigating Regulations and Realizing Opportunities.” The event attracted a diverse group of medtech leaders, government officials, and regulatory experts. Their aim was to explore Hong Kong’s rising role as a medtech hub and its strategic importance in connecting to Mainland China, particularly via the Greater Bay Area (GBA). Cisema, was represented by Senior Manager Jacky Li, who was an invited speaker, sharing key regulatory insights and highlighting strategic opportunities tied to the GBA Connect scheme.
InvestHK Keynote Insights: Hong Kong as a Strategic MedTech Hub
The seminar opened with remarks from Ms. Alpha Lau, Director-General of Investment Promotion at Invest Hong Kong. Following this, Professor Philip Chiu, Dean of the Faculty of Medicine at The Chinese University of Hong Kong, delivered the keynote. Professor Chiu underscored Hong Kong’s unique positioning, bolstered by its world-class research institutions, infrastructure, and proximity to the GBA. These factors enable Hong Kong to emerge as a medtech innovation powerhouse in Asia.
Regulatory Pathways: Critical Knowledge for MedTech Market Entry
The seminar continued with a detailed explanation of the Medical Device Administrative Control System (MDACS) by Mr. Tommy Lam from the Department of Health. This session was especially valuable for international medtech firms seeking entry into Hong Kong.
Cisema’s Jacky Li presented the regulatory essentials for leveraging the GBA Connect Scheme. He explained how collecting real-world data (RWD) from designated GBA hospitals is streamlining the National Medical Products Administration (NMPA) approval process. Jacky also emphasized that MDACS listing in Hong Kong is becoming increasingly important for public procurement. This applies to both Hong Kong and the broader GBA.
Jacky’s presentation provided a critical takeaway: companies that strategically utilize the GBA Connect scheme can significantly accelerate their path to China’s lucrative medtech market. He provided practical insights into how medtech firms can reduce time-to-market by leveraging existing clinical data from GBA hospitals, bypassing the need for extensive clinical trials in China itself—a compelling advantage for early movers in the industry.
Industry Perspectives: Quality, Compliance, and Innovation
Don Lee of SGS Hong Kong emphasized the growing importance of robust certification and quality management systems. These are key for ensuring market entry and sustained success in China. Lee’s session stressed that stringent regulatory requirements demand comprehensive compliance frameworks, which are crucial for long-term growth.
InvestHK Panel Discussions: Driving Innovation and Market Growth
Two panel discussions further enriched the event. The first panel, moderated by Andy Wong from Invest Hong Kong, focused on MedTech Innovation: From Research to Commercialisation. Panelists included:
- Ms. Scarlett Chen, Managing Partner, Verge Health Tech Fund
- Dr Grace Lau, Head of Institute for Translational Research, Hong Kong Science & Technology Parks Corporation
- Prof Peng Shi, Department of Biomedical Engineering, City University of Hong Kong
- Dr Kenneth Tsang, CEO, Gleneagles Hospital Hong Kong
This session explored how research can become commercially viable products. Panelists discussed the importance of clinical validation and the role of incubators and accelerators in advancing medtech innovations to market. The second panel, moderated by Ms. Cathy Lui, explored MedTech Opportunities in Hong Kong. Panelists include:
- Mr Dennis Guo, Managing Director, Joint Wise Innotech Limited
- Dr Lydia Leung, Chairman, Hong Kong Medical and Healthcare Device Industries
- Prof Christopher Schuhmacher, Director, Schuhmacher Consulting Limited
- Mr Simon Yeung, COO, Time Medical
This session delved into Hong Kong’s role as a critical entry point for medtech companies expanding into China or growing globally. The panelists shared insights on evolving market dynamics. They also emphasized how Hong Kong’s strategic position within the GBA offers a two-way gateway for business growth.
Key Takeaways for MedTech Stakeholders
- Hong Kong’s Pivotal Role as a MedTech Gateway:
With its advanced regulatory framework and strategic location within the GBA, Hong Kong is perfectly positioned to be a medtech bridge between China and global markets. Cisema’s expertise in navigating these regulatory complexities offers companies a streamlined pathway to success.
- GBA Connect Scheme’s Strategic Advantage:
The GBA Connect Scheme is reshaping market access for medtech firms. It enables the use of RWD from GBA hospitals to expedite NMPA approvals. For companies looking to break into China, this represents a significant reduction in both time and cost.
- Quality Compliance is Essential:
As regulatory frameworks in Hong Kong and China evolve, maintaining high standards of certification and quality management is non-negotiable. Medtech companies must prioritize these elements to achieve sustainable market entry and growth.
- Innovation to Commercialization:
The journey from research to a market-ready product is challenging, but Hong Kong’s innovation hubs and accelerator programs provide invaluable support to medtech companies navigating regulatory hurdles and clinical validations.
Cisema’s Role in Facilitating Regulatory Success
At Cisema, we pride ourselves on providing deep regulatory expertise, particularly around the complexities of market entry into China via the GBA. Our presentation at this seminar highlighted the value of strategic regulatory planning and early engagement with the GBA Connect Scheme to fast-track approval processes. Beyond Hong Kong, we continue to advise medtech companies on navigating the regulatory landscapes in Mainland China.
We regularly host seminars, webinars, and speak at international conferences such as Medica, providing up-to-date insights on regulatory developments across industries, including medical devices, pharmaceuticals, cosmetics, and consumer goods.
If your company is exploring market opportunities in Hong Kong, the GBA, or China, reach out to us for tailored advice or to invite us to speak at your next event.
