I. Training theme
To accelerate the convergence, harmonization, and reliance of global medical device regulation, and further enhance the regulatory capabilities of countries/regions around the globe, GHWP decides to host the 3rd Offline Training 2025 through GHWP (Guangzhou) Academy. The training is themed on “Bio-Material Based Regulatory Science Supports Global Health”.
Considering the feedback from the two trainings in 2024 and previous research, the 3rd Training 2025 will combine global and regional industrial development trends and regulatory hot topics. It will focus more on policies, standards, regulatory trends and regulatory practice in the field of “advanced biomaterials and innovative medical devices”, exploring cutting-edge technologies and industries, and inviting well-known speakers of international regulation as well as top academicians and experts.
Highlights of the training:
II. Training organizations
Host: Global Medical Device Regulatory Harmonization Council (Guangzhou Academy)
Organizer: Guangdong Institute of Advanced Biomaterials and Medical Devices
Supporting organizations (to be updated, listed in no particular order):
China Association for Medical Devices Industry
Asia Pacific Medical Technology Association (APACMed)
Guangdong Association for Medical Devices Industry
Shanghai Yangtze River Delta Medical Device Industry Development Promotion Association
National Engineering Research Center for Tissue Restoration and Reconstruction
Guangzhou International Bio-island Co., Ltd.
Reed Sinopharm Exhibitions Co., Ltd.
Guangzhou High-tech Investment Group
III. Training time and venue
Time: May 14–16, 2025 (full-day registration on May 13)
Venue: 3F, Banquet Hall, Vignette Collection, the Xanadu Guangzhou
(No. 1 Xingdao Huannan Road, International Bio-island, Haizhu District, Guangzhou)
Transportation guide:
-By driving/car: Set the destination as “Vignette Collection, the Xanadu Guangzhou” in the navigation system.
-By metro: Take Guangzhou Metro Line 4 (to Nansha Passenger Port), get off at Exit B of “Guanzhou Station”, and take the shuttle bus to the hotel (please refer to the bus shuttle timetable).
| Shuttle venue | Time | Remarks: |
|---|---|---|
| Exit B of Guanzhou Station – Conference Hall | 8:15–20:15 (30 min/trip) | -Hotel pick-up venue: Outside the main entrance of the hotel lobby on the first floor; -Shuttle buses will be provided according to hotel arrangement. |
IV. Training content and mode
The training will include Lectures, Panel Discussions, Parallel Exchange and On-site Training. In principle, no lectures will be given during the On-site Training. Q&A can be arranged according to the requirement. Topic 1 will be arranged via free online live streaming.
After completing the required training hours, formal trainees will receive the Certificate of Completion for “Global Medical Device Regulatory Capacity Improvement Program” issued by GHWP (Guangzhou) Academy.
Appendix 1
AGENDA (updating)
| Date | Time | Agenda | Guests | |
|---|---|---|---|---|
| 2025/5/13 | All day | Registration | ||
| 2025/5/14 | 8:00-8:30 | Sign in | ||
| Topic 1: GHWP Promotion of Global Medical Device Regulatory Convergence, Coordination, and Trust | ||||
| 2025/5/14 | 9:00-9:30 | Speech by the Chairperson of GHWP | ||
| 9:30-10:00 | Global Medical Device Regulatory Convergence, Coordination, and Trust- GHWP Work Progress | Tran Quan Member of GHWP Strategic Advisory Board | ||
| 10:00-10:30 | Development Trends and Characteristics of Advanced Biomaterials | Academician Wang Yingjun President of GHWP (Guangzhou) Academy | ||
| 10:30-10:45 | Global Medical Device Industry Innovation and Development Report Launching | |||
| 10:45-11:15 | Group photo and tea break | |||
| 11:15-11:45 | Hot Topics and Development Trends in Global Regulation of Advanced Biomaterials and Innovative Medical Devices | Alfred Kwek Member of GHWP Strategic Advisory Board | ||
| 11:45-12:15 | Innovation Trends of Global Advanced Biomaterials and Medical Device Industry | Experts of APACMED and GMTA | ||
| 12:15-14:00 | Lunch | |||
| Topic 2: Review Requirements and Common Issues for Innovative Biomaterials Passive Medical Devices in China | ||||
| 2025/5/14 | 14:00-14:40 | Interpretation of Innovative Medical Device Regulation Policies in China | Zhang Wenyue Registration Administration Department of National Medical Products Administration | |
| 14:40-15:20 | Pre-marketing Rules of Passive Medical Devices (Cardiovascular Implantable and Interventional Medical Devices) | Cheng Maobo Evaluation Department III of Center for Medical Device Evaluation, NMPA | ||
| 15:20-15:50 | Tea break | |||
| 15:50-16:30 | Pre-marketing Rules of Passive Medical Devices (Orthopedic and Dental Medical Devices) | Zhang Jiazhen Evaluation Department IV of Center for Medical Device Evaluation, NMPA | ||
| 16:30-18:00 | Closed-door Meeting (Directed Invitation) | |||
| Topic 3: Innovation and Regulation of Advanced Biomaterials Medical Device Industry | ||||
| 2025/5/15 | 9:00-9:30 | Progress of Scientific Research on Review of Innovative Biomaterial Medical Devices in China | Liu Yinghui Director of Integrated Business Department, Centre for Medical Device Evaluation, NMPA | |
| 9:30-9:50 | Application and Prospect of Biomaterials in Regenerative Medicine | Jia Renkai Chief Registration Specialist, Medtronic (Shanghai) Management Co., Ltd. | ||
| 9:50-10:10 | Regulatory Empowerment for Industrial Innovation Practice - Recombinant Humanized Collagen Protein | Lu Chenyang Deputy General Manager, Shanxi Jinbo Bio-Pharmaceutical Co., Ltd. | ||
| 10:10-10:30 | Regenerative Medicine Technology Empowers a New Future for Human Health, Beauty and Longevity | Cheng Shiyu Medical Founder and CEO, Roumai Medical (Shenzhen) Co., Ltd. | ||
| 10:30-10:50 | Tea Break | |||
| 10:50-11:10 | Innovation Practice in Orthopedic Industry in China Based on 20 Years of Orthopedic R&D Experience | Wang Caimei CTO, iKang Healthcare Group Director of R&D Center, Beijing AKEC Medical Equipment Co., Ltd. | ||
| 11:10-12:00 | Panel Discussion on Regulatory Empowerment Industry Innovation (Regulatory representative + Industry representative) | |||
| 12:00-14:00 | Lunch | |||
| 14:00-14:30 | Training on Medical Device Regulation in Malaysia, ASEAN | Sasikala Devi Thangavelu Senior Medical Device Consultant CEO, MdDev Sdn Bhd Visiting Professor, University of Malaya (Former Director General of the Medical Device Authority, Malaysia) | ||
| 14:30-15:00 | Training on Medical Device Regulation in Indonesia, ASEAN | Helsy Pahlemy Ministry of Health of Indonesia | ||
| 15:00-15:30 | Tea break | |||
| 15:30-16:00 | Training on Passive Medical Device Regulation in Korea, East Asia | Sunny Woo Head of International Affairs Group of Korea Medical Devices Industry Association (Former Medical Device Reviewer of Ministry of Health and Welfare of South Korea) | ||
| 16:00-16:30 | Training on Medical Device Regulation in Uzbekistan, Central Asia | Khilola Nazrullayeva Senior Expert in Innovative Medical Devices | ||
| 16:30-17:00 | Training on Medical Device Regulation in Ghana, West Africa | Mr. Emmanuel Nkumah Director, Food and Drugs Authority, Ghana Person in charge of medical device regulation | ||
| 17:00-17:30 | Training on Medical Device Regulation in Botswana, Southern Africa | Bathusi Kgosietsile Director, Product Evaluation & Registration Medicines Regulatory Authority | ||
| 17:30-18:00 | Panel Discussion | Speakers of Topic 3, Representatives of regulatory agencies of countries/regions | ||
| Topic 4: Clinical Application and Regulation of Innovative Medical Devices | ||||
| 2025/5/16 | 9:00-9:30 | Scientific and Standardized Practice of Clinical Evaluation System for Implantable and Interventional Medical Devices(TBD) | Jia Jianxiong Clinical Department I of Center for Medical Device Evaluation, NMPA | |
| 9:30-10:00 | Trends in the Clinical Application of International Innovative Medical Devices | Authoritative Overseas Clinical Expert | ||
| 10:00-10:30 | Tea break | |||
| 10:30-11:00 | R&D and Clinical Application Demands of Innovative Medical Devices in Ophthalmology | Lin Haotian Director, Zhongshan Ophthalmic Center of Sun Yat-sen University, and President, Ophthalmic Hospital | ||
| 11:00-11:30 | Biomaterials Facilitate the Rapid Development of Stomatology | Chen Lili Dean, Guanghua School of Stomatology of Sun Yat-sen University, and Executive Vice President, Hospital of Stomatology, Sun Yat-sen University | ||
| 11:30-12:00 | Panel Discussion | Speakers of Topic 4, representatives of regulatory agencies of countries/regions | ||
| 12:00-12:15 | Completion Ceremony | |||
| Topic 5: On-site training | ||||
| 2025/5/16 | 14:00-17:00 | On-site training | ||
| 2025/5/16 | Participants Depart | |||
(The schedule and speaker arrangement may be adjusted according to the actual situation.)
V. Registration method
(Scan the QR code to register)
VI. Training fee
Each GHWP regulatory agency of country/region is entitled to free-of-charge training for 1 participant. Council members of GHWP (Guangzhou) Academy are eligible for discounts in accordance with the Council Charter. The training fee for other participants is RMB 9,800/person, which covers tuition, materials and meals (accommodation and transportation are at the participant’s own expense).
Registration is confirmed upon receipt of payment. When making the payment, please indicate GHWP Training + Name + Phone No.
Account details:
Account name: Guangdong Institute of Advanced Biomaterials and Medical Devices
Account No.: 44063801040014354
Opening bank: Guangzhou Donghuicheng Branch, Agricultural Bank of China
VII. Contact information and registration
GHWP (Guangzhou) Academy Huang Siyuan 13066385094
Sylvia Wang 13143128423
ghwpreg@163.com
Participation guide
I. Lunch will be provided during the training (May 14-16). Participants are responsible for their transportation and accommodation.
II. The hotels with negotiated rates are available for reference. Please contact them for reservation.
Conference hotel:
Vignette Collection, the Xanadu Guangzhou
Address: No. 1 Xingdao Huannan Road, International Bio-island, Haizhu District, Guangzhou
Contact: Manager Ye 18620829941
| Room rates | ||
|---|---|---|
| Negotiated rate | Market rate | |
| Deluxe River View Room | RMB 700 /room/night (breakfast for 1 person) RMB 800/room/night (breakfast for 2 persons) | RMB 1,013/room/night |
| Exclusive River View Room | RMB 700 /room/night (breakfast for 1 person) RMB 800/room/night (breakfast for 2 persons) | RMB 1,141/room/night |
| One-Bedroom Suite | RMB 1,850/room/night (breakfast for 2 persons) | RMB 2,241/room/night |
Recommended hotel:
1. Bio-island International Apartment
Address: No. 108 Xingdao Huannan Road, International Bio-island, Haizhu District, Guangzhou
Contact: Manager Zhuo 15920893089
Transportation options:
- Walk for 1.7 km to the venue
-5 minutes by Bus No. 353/Bio-island South Line/Bio-island Line 1
-About 7-10 minutes by driving
| Room rates | |||
|---|---|---|---|
| Room type | Bed type | Floor area (m²) | |
| Superior One-Bedroom Apartment | Single bed | 70m² | |
| Superior Two-Bedroom Apartment | Double bed | 105m² | |
| Breakfast not included. Additional breakfast is charged at RMB 68/person. | |||
2. GHIC The Mulian Hotel of Bio-island Guangzhou
Address: Building B3, No. 96 Xingdao Huannan Road, International Bio-island, Haizhu District, Guangzhou
Contact: Manager Zhong 13632268319
Transportation options:
- Walk for 1.9 km to the venue
-5 minutes by Bus No. 353/Bio-island South Line/Bio-island Line 1
-About 7-10 minutes by driving
| Room rates | |||
|---|---|---|---|
| Room type | Negotiated rate | Number of rooms | Breakfast |
| Standard King Room | RMB 450/room/night | 20 | Breakfast for 1 person |
| Standard Double Room | RMB 500/room/night | 50 | Breakfast for 2 persons |
| Executive King Room | RMB 550/room/night | 40 | Breakfast for 1 person |
| Two-Bedroom Family Room | RMB 600/room/night | 60 | Breakfast for 2 persons |
| Business Suite | RMB 600/room/night | 30 | Breakfast for 1 person |