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.

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