Submitted by admin on Tue, 05/28/2024 - 14:26

Innovative Medical Devices Embrace the World: The 1st Training of GHWP (Guangzhou) Academy Successfully kicked-off

In the morning of May 27th, the GHWP (Global Harmonization Working Party) (Guangzhou) Academy held its inaugural training session at South China University of Technology in Guangzhou. The event was attended by over 300 participants, including representatives from 12 regulatory authorities of GHWP member countries and regions, representatives from 5 international organizations, and delegates from global medical device industry. The training is jointly organized by GHWP (Guangzhou) Academy and Guangdong Institute of Advanced Biomaterials and Medical Devices. EunHee Cho, GHWP vice chair of industry, presided the opening ceremony. Dr. Xu Jinghe, the GHWP Chair and Deputy Commissioner of the National Medical Products Administration of China (NMPA), attended the ceremony and delivered an opening remark.

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EunHee Cho, GHWP Vice Chair of Industry

In his speech, Dr. Xu congratulated the GHWP (Guangzhou) Academy on its first training session and highlighted the theme, Collaborative EmpowermentInnovative Medical Devices Embrace the World. He emphasized the significance of this training in strengthening global regulatory exchanges and mutual learning, as well as in promoting innovation and development of the global medical device industry. Xu noted that in the context of expanding global trade, there is an increasing demand for regulatory convergence, harmonization, and reliance. It is expected to see more innovative medical device products being better accessible to the global market, in terms of effectiveness, smoothness and convenience, bringing greater hopes and benefits to the public health globally.

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Dr. Xu Jinghe

GHWP Chair, Deputy Commissioner of NMPA

Xu Yong, Chair of the GHWP (Guangzhou) Academy and Vice President of South China University of Technology, delivered a speech at the opening ceremony. He expressed that the GHWP Academy will actively promote regulatory capacity building in GHWP member countries and regions. He hoped this training will provide a broad platform for learning and exchange for the participants, and he wished the training a great success. Yingjun Wang, President of the GHWP (Guangzhou) Academy, Dean of Guangdong Institute of Advanced Biomaterials and Medical Devices and an Academician of the CAE, attended the session and extended a warm welcome to the trainees.

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Xu Yong

Chair of GHWP (Guangzhou) Academy,

Vice President of SCUT

After the opening ceremony, Mr Gao Guobiao, GHWP SAB Member, Party Secretary of Center for Medical Device Evaluation, NMPA, kicked-off the first topic of the training session with his speech "Promoting Global Medical Device Regulatory Convergence, Harmonization, And Reliance - Overview of GHWP". Ms. Tran Quan, GHWP SAB Member and Quality Assurance and Regulatory Affairs of Baxter, gave keynote speeches on "GHWP Moving towards the 2026 Strategic Framework".

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Gao Guobiao

GHWP SAB Member,

Party Secretary of Center for Medical Device Evaluation, NMPA

 

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Tran Quan

GHWP SAB member and Quality Assurance

and Regulatory Affairs of Baxter

GHWP, originally known as the Asian Harmonization Working Party (AHWP), was officially rebranded in December 2021 to reflect its growing global membership. It is currently the only international platform dedicated to the coordination of medical device regulations, involving representatives from both regulatory authorities and the industry. Today, GHWP has members from 34 countries and regions, extending its reach from Asia to South America and Africa, and covering nearly 60% of the global population. GHWP has issued 56 technical guidelines and delivered more than 40 online and offline training sessions, all aimed at enhancing the regulatory capacity of its member countries and regions.

In response to the new challenges of global medical device regulation, GHWP established the world's first Academy last yearGHWP (Guangzhou) Academy. Wang Yingjun, academician of the CAE and professor of South China University of Technology (SCUT) served as the dean of the academy. Utilizing academic resources of the SCUT, GHWP (Guangzhou) Academy will develop a systematic curriculum on regulatory harmonization and cutting edge medical device technologies. Aiming at building a platform for regulatory capacity enhancement, The Academy will invite regulators and experts of medical device sector from GHWP member countries and regions to delivery lectures and conduct discussions, promoting training and application of regulations, enhancing regulatory capacity in member countries and regions, and realizing global convergence, harmonization, and reliance. The Academy is committed to facilitate the development of the medical device industry and to ensure the safety and efficacy of medical devices for the benefits of the public health and patients globally. 

Over this 5-day training, five key topics will be covered, namely "GHWP Promotes Global Medical Device Regulatory Convergence, Harmonization, and Reliance", " Global Medical Device Industry Innovation Development and Outlook", "Global Premarket Regulatory Framework of Medical Devices", "Practices of Chinese Innovative Medical Device Enterprises," and "Innovative Medical Device Enterprises Going Global, Sharing and Exchanges". The training aims to further enhance the regulatory capacity of the Global Harmonization Working Party (GHWP) member countries and regions, and to further promote the innovative medical devices to ultimately benefits all patients worldwide.

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Group Photo