The Kingdom of Saudi Arabia, represented by the Saudi Food & Drug Authority (SFDA) and G20 Saudi Secretariat, hosted last Tuesday a virtual meeting with the leaders of the Global Harmonization Working Party (GHWP) of Medical Devices (scientific and technical groups), as a part of the activities of the international conferences program held on the sidelines of Saudi Arabia’s presidency of the G20.

The meeting was held with the honor of H.E the CEO of SFDA, Prof. Hisham bin Saad Al-Jadhey, with the participation of more than 31 representatives of member states of the organization, the organization’s counselors and representatives from the United States of America and Japan.  

The Chairman of the GHWP and Vice Executive President for the Medical Devices Sector at SFDA, Eng. Ali Al-Dalaan, explained that the meeting discussed the stages of progress in the organization’s strategic plan, the work of regulatory legislation and technical requirements from each work group, as well as capacity building and competencies, especially after the organization's transformation from an Asian into a global organization.

He added that the meeting reviewed the integrative role between member states regarding the Coronavirus (COVID-19) pandemic, in participation of chairs of scientific and technical groups of the organization and World Health Organization (WHO), in addition to the participation of International Medical Devices Regulators Forum (IMDRF), with a presentation about Coronavirus (COVID-19) updates.   

The Global Harmonization Working Party (GHWP) is one of the largest parties in the world, which specialized in global harmonization and convergence for medical devices. The organization aims to develop regulatory legislation between 31 countries; the most prominent countries are Saudi Arabia, China, Singapore, Malaysia, South Korea, Kazakhstan, South Africa, Indonesia, Kyrgyzstan, India, Vietnam and Philippine) by studying the regulatory updates related to medical devices and products as well as developing the regulations and guidelines through 9 scientific and technical work groups.       

Saudi Arabia participated in all the scientific and technical groups of GHWP with specialized and experienced members. Additionally, it chaired two working groups for pre-marketing requirements - medical software, and quality management system for medical devices: audit and evaluation.

During the Kingdom of Saudi Arabia's chairmanship of the organization, the member states agreed to the proposal of Saudi Arabia to change the name to a global organization, in order to achieve more harmony and global convergence with the regulatory authorities and bodies, thus ensuring the safety and efficacy of medical devices and in diagnosis, treatment and other medical applications in accordance with international best practice.

The organization is working on ongoing coordination with a number of strategic partners and other organizations, such as (APEC), (WHO), (OECD), (ISO) and (International Medical Devices Regulators Forum).

Saudi Arabia’s leadership of this organization is based on working on homogeneity and convergence in legislation and regulatory regulations for medical devices and between countries and encourages investors in the field of manufacturing medical devices and products to enter the Saudi market. Moreover, facilitates the entry of innovative medical devices and products, modern technologies and stimulates research and development through scientific research development and innovation processes in the field of modern medical technology.