Medical Device Regulation in the Guangdong-Hong Kong-Macao Greater Bay Area

A Practical Guide for Compliant and Efficient Market Entry

Inbunden, Engelska, 2026

2 959 kr

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As the Greater Bay Area (GBA) emerges as one of Asia’s most strategically significant medtech markets, navigating its fragmented regulatory landscape remains a critical challenge for manufacturers and distributors alike. This book is the first comprehensive, practitioner-oriented guide to medical device regulation across Hong Kong, Macau, and the nine GBA mainland cities—equipping companies with the tools to enter markets faster and with full regulatory confidence. Spanning Hong Kong’s transition from voluntary MDACS to statutory regulation, Macau’s newly enacted medical device law, and GBA integration strategies, the book provides end-to-end guidance from classification and listing through post-market surveillance and enforcement readiness.

Produktinformation

Utgivningsdatum2026-10-06
Mått152 x 229 x undefined mm
FormatInbunden
SpråkEngelska
Antal sidor178
FörlagJenny Stanford Publishing
ISBN9789815352382

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Jack Wong has more than 26 years’ experience in pharma and MedTech sectors. He is the founder of the Asia Regulatory Professionals Association (ARPA), an Asia Not-for-Profit organization for regulatory education, with more than 9900 members; author of Medical Regulatory Affairs Handbook (4th edition); adjunct associate professor/lecturer at The Chinese University of Hong Kong (CUHK), Hong Kong University, National University of Singapore, and Tohoku University, Japan; and CEO of RNAscence (a biotech start-up spin off from Nanyang Technological University and National Skin Centre, Singapore) and CareerPassion.ai. Raymond K. Y. Tong is the founding chairman of Biomedical Engineering at CUHK. He established the first Biomedical Engineering department in Hong Kong. A leader in rehabilitation robotics and medicaldevice translation, he serves as Academic Chairman of Hong Kong’s Local Responsible Person (LRP) Panel, bridging industry and regulators. As an educator, Prof. Tong designed CUHK’s biomedical engineering curriculum and mentored generations of MedTech and HealthTech professionals. His research spans robotics, brain–computer interfaces, and clinical trials, driving safe clinical adoption. He is a Fellow of the American Institute for Medical and Biological Engineering and a recipient of Hong Kong’s Ten Outstanding Young Persons award.

1. Support and Participation in the Medical Device Regulatory Initiatives in the Greater Bay Area: Hong Kong SAR, Macao SAR, and Nine Mainland Cities (Guangzhou, Shenzhen, Zhuhai, Foshan, Huizhou, Dongguan, Zhongshan, Jiangmen, and Zhaoqing). Part I: Hong Kong: Current Practice, Transition, and Preparation. 2. Current Regulatory Landscape of Medical Devices in Hong Kong. 3. Preparing for Hong Kong’s Statutory Regime and Centre for Medical Products Regulation. 4. Hong Kong in Practice: Selecting and Managing Local Responsible Persons (LRPs), Compliance Readiness and Experience. Part II: Macao: New Law and Practical Implementation. 5. The Medical Device Industry in Macao: Overview of Market Dynamics and Regulatory Frameworks. 6. Macao in Practice: Challenges and Enablers to Support the Implementation of the Medical Device Law in Macao. Part III: Greater Bay Area: Integration and Strategy. 7. Greater Bay Area: Using Hong Kong and Macao as Gateways. 8. Strategic Comparison: Hong Kong vs. Macao vs. Chinese Mainland (GBA Focus). Part IV: Outlook and Action Plan. 9. Future Outlook and 90-Day Action Plan.