I. Training Theme
To accelerate global convergence, harmonization, and reliance in medical device regulation while further strengthening regulatory capabilities across member countries/regions, the GHWP will hold the 4th GHWP (Guangzhou) Academy training. The training theme is "High-quality medical devices contribute to global public health".
Based on the feedback from the first three training sessions and preliminary research, the 4th training program will align with global and regional industrial development trends as well as regulatory hotspots. It will focus on cutting-edge fields and key areas of industry and regulation, such as high-end medical devices, home-use medical devices, IVD, and orthopedic medical devices. The training will place greater emphasis on policy, standard, and regulatory trend analyses, as well as regulatory practices, while exploring the frontiers of technology and industry. Additionally, it will invite frontline international regulatory speakers and top academicians specialists to deliver lectures.
II. Training Organizations
Host:
Global Medical Device Regulatory Harmonization (Guangzhou) Academy
Guangdong Institute of Advanced Biomaterials and Medical Devices
Organizer:
Chongqing High-Tech Zone Biopharmaceutical Industry Chain Task Force
Chongqing Orthopaedic Technology Institute
Guiding organizations:
Chongqing Medical Products Administration
Chongqing High-Tech Industrial Development Zone Management Committee
Supporting organizations (listed in no particular order):
China Association for Medical Devices Industry
Chinese Society for Biomaterials
Chinese Society Of Biomedical Engineering
Asia Pacific Medical Technology Association (APACMed)
National Engineering Research Center for Tissue Restoration and Reconstruction
All Council Members of the Global Harmonization Working Party (GHWP) Academy
III. Training Time and Venue
Time: November 17–20, 2025 (Full-day Registration on November 17)
Venue: Chongqing Science Hall (At the intersection of Science Avenue and High-tech Avenue, Jiulongpo District, Chongqing City)
IV. Training Content and Methods
This training program will combine lectures, panel discussions, parallel exchange, and on-site training. In principle, no lectures will be arranged for the on-site training session, while Q&A sessions may be organized if necessary.
Upon completing the required training hours, official participants will be awarded the "Global Medical Device Regulatory Capacity Enhancement" completion certificate issued by GHWP (Guangzhou) Academy.
V. Registration Method
VI. Training Fee
Each regulatory authority from GHWP member countries/regions is entitled to 1 tuition-waived quota.
Council member of GHWP (Guangzhou) Academy are entitled to applicable discounts as per the academy’s council charter.
For other trainees, the training fee is RMB 4,500 per person, covering tuition, teaching materials fees and meal fees (accommodation and transportation at own expense).
| Price | Early Bird Price (Registration and payment before October 25th, 2025) |
|---|---|
| RMB 4,500 per person | RMB 3,500 per person |
VII. Training Schedule
Training Schedule Arrangement
| Date | Time | Agenda | Speaker |
|---|---|---|---|
| November 17th, 2025 | All Day | Registration | |
| November 18th, 2025 | 8:00-8:30 | Sign in | |
| Topic 1: GHWP Promotes Global Convergence, Harmonization and Reliance in Medical Device Regulation | |||
| November 18th, 2025 | 8:30-9:00 | Welcome Speech | |
| 9:00-10:00 | Global Convergence, Harmonization and Reliance in Medical Device Regulation - GHWP Work Progress | GHWP Leadership | |
| 10:00-10:30 | Academician's Report | (TBC) | |
| 10:45-11:15 | Group Photo & Tea Break | ||
| 11:15-11:45 | Global Practices in Medical Device Regulatory Harmonization | Expert from WHO | |
| 11:45-12:15 | Global Industry Trends | Global Industry Experts | |
| 12:15-14:00 | Lunch | ||
| Topic 2: Review Requirements and Common Issues for High-end Medical Devices in China | |||
| November 18th, 2025 | 14:00-14:30 | Innovation and Development of Medical Devices-Progress of Medical Device Technical Review Work | Leaders from CMDE of NMPA |
| 14:30-15:00 | Progress of Technical Review for High-end Medical Devices | Experts from CMDE of NMPA | |
| 15:00-15:30 | Tea Break | ||
| 15:30-16:00 | Progress of Technical Review for High-end Medical Devices | Experts from CMDE of NMPA | |
| 16:00-16:30 | Progress of Technical Review for High-end Medical Devices | Experts from CMDE of NMPA | |
| 16:30-18:00 | Closed-door Seminar (Invitation-only) 4th Meeting of the 1st Council (Parallel Session) | ||
| Topic 3: Development and Regulatory Frontiers of Global Medical Device Industry | |||
|---|---|---|---|
| November 19th, 2025 | 9:00- 9:30 | Regulatory Progress of Medical Devices in East Asia Region | Senior Experts in Medical Device Regulation in East Asia Region |
| 9:30-10:00 | Regulatory Policies and Practices of Medical Devices in ASEAN Region | Representatives/Experts from Regulatory Authorities in ASEAN Region | |
| 10:00-10:30 | Tea Break | ||
| 10:30-11:00 | Medical Device Registration Practices and Regulatory Hotspots in Representative Southeast Asian Countries/Regions | Representatives/Experts from Regulatory Authorities in Representative Southeast Asian Countries/Regions | |
| 11:00-11:30 | Progress of Regulatory Harmonization and Reliance-building between North Africa and Asia | Representatives from Regulatory Authorities in North Africa Region | |
| 11:30-12:00 | Regulatory Frontiers of Medical Devices in Asia-Pacific Region | Senior Experts in Medical Device Regulation in Asia-Pacific Region | |
| 12:10-14:00 | Lunch | ||
| 14:00-14:30 | Introduction to Malaysia's Medical Device Industry Policies and Market Access | Heads/Senior Experts of Malaysia's Medical Device Industry Association | |
| 14:30-15:00 | Current Status of Indonesia's Medical Device Market and Industry Opportunities for China | Heads/Senior Experts of Indonesia's Industry Association | |
| 15:00-15:30 | Tea Break | ||
| 15:30-16:00 | Introduction to Medical Device Industry Development and Regulatory Policies in the Americas | Heads/Senior Experts of the Inter-American Coalition for Regulatory Convergence (IACRC) | |
| 16:00-16:30 | Introduction to Medical Device Industry Development and Regulatory Policies in Middle East-North Africa | Heads/Senior Experts of the Middle East Council of Medical Devices, Imaging & Diagnostics (MECOMED) | |
| 16:30-17:00 | Current Status and Regulatory Frontiers of Medical Device Markets in EU/North America | Former Experts from EU/North American Regulatory Authorities | |
| 17:00-18:00 | Panel Discussion | Speakers of Topic 3, representatives from national/regional regulatory authorities and industry representatives | |
| Topic 4: Regulatory Reform of Medical Device Clinical Trials and Frontiers of Medical-Engineering Transformation | |||
| November 20th, 2025 | 9:00-9:30 | Progress of Regulatory Reform for Clinical Trials of High-end Medical Devices | Experts from CMDE of NMPA |
| 9:30-10:00 | Clinical Application and Medical-Engineering Transformation of Cutting-edge Medical Devices | Senior Clinical Experts | |
| 10:00-10:30 | Tea Break | ||
| 10:30-11:00 | Practice of Medical-Engineering Transformation and Clinical Application of Innovative Medical Devices | Senior Clinical Experts | |
| 11:00-11:30 | Practice of Clinical Pathways for Innovative Medical Devices | Industry Experts | |
| 11:30-12:00 | Panel Discussion | Speakers of Topic 4, representatives from national/regional regulatory authorities | |
| Topic 5: On-site Training | |||
| November 20th, 2025 | 14:00-17:00 | On-site Training | |
| November 21th, 2025 | All Day | Participants Depart | |
(The schedule and speaker arrangements may be adjusted according to actual circumstances.)
VIII. Cooperation Opportunities
This training offers multiple cooperation opportunities, including sponsorship, speaking, booth display, etc., aiming to provide high-value exposure and communication opportunities for partners.
Contact Person for Cooperation Inquiry: Hu Zhizhi, 18008336333
IX. Registration Inquiry
Contact for Training Registration: Conference Affairs Team - Licht
Phone Number: 15112941387, Email: 1552495351@qq.com
X. Conference Guidelines
Lunch will be provided during the training (November 18-20). Transportation and accommodation are at participants' own expense.
