GHWP Leaders Stress Importance of Supporting Innovation, Convergence in Medical Devices Regulations, Legislation Between Countries
2023-02-16
Leaders of the Global Harmonization Work Party (GHWP) for Medical Devices concluded their 26th annual meeting today in Riyadh, hosted by the Kingdom of Saudi Arabia, represented by the Saudi Food and Drug Authority (SFDA). The leaders stressed the importance of harmonization and convergence in the regulations and legislation of medical devices and supplies among the countries in the world. The meeting was attended by the H.E. CEO of SFDA, Dr. Hisham bin Saad Aljadhey; H.E. Deputy Minister of Industry and Mineral Resources, Eng. Osama Al-Zamil; H.E. Deputy Minister of Health for Planning and Development, Eng. Abdulaziz Al-Rumaih; the Assistant Minister of Health, Dr. Mohammed Al-Abdulaali; the Director General of Medical Services in the Armed Forces, Dr. Ahmed Al-Ameri; and the CEO of the Public Health Authority, Abdullah Al-Quwaizani and GHWP Chair and Executive Vice President of the Medical Devices Sector at SFDA, Eng. Ali Al-Dalaan. The meeting also was attended by representatives of the 33 regulatory bodies, international alliances and associations other than member states, such as the World Assembly of Manufacturers of Diagnostic Medical Imaging and Radiation Therapy Devices, the World Health Organization, the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the International Medical Device Coding Organization, the Asia Pacific Medical Technology Association, the Asia-Pacific Economic Cooperation (APEC), Association of Southeast Asian Nations, Pan American Network on Drug Regulatory Harmonization, Africa Medical Devices Forum (AMDF) and the Global Medical Technology Alliance (GMTA). At the end of the meeting, GHWP recommended updating and developing legislation and technical requirements that support innovation processes in medical devices and supplies, modern technologies, digital health, artificial intelligence and its applications in the medical field, and medical software by accelerating the harmonization and convergence of systems between countries. Participants in the meeting also recommended strengthening scientific efforts through scientific and clinical evaluation of the device and medical supplies, clinical studies, and monitoring of medical devices and supplies to ensure continuity of safe and efficient performance in diagnosis and treatment. The attendees discussed the importance of the capacity building program in the regulatory and legislative field and developing it to serve the regulatory authorities and factories, praising the GHWP’s role. On the sidelines of this meeting, a bilateral meeting was held between the Global Harmonization Working Party and the International Medical Devices Regulators Forum. They discussed enhancing cooperation between the two sides to serve the regulations and regulatory legislation for medical devices and supplies. Eng. Ali Al-Dalaan explained that the Kingdom has had an important and leading role in the GHWP through its presidency since 2018 and its transformation from an Asian organization to a global one that includes 33 oversight bodies from different countries around the world. He stressed the approval of several projects and guides by the various work teams of the GHWP during the meeting. It is noteworthy that the Kingdom hosted this event in addition to the 26th annual meeting of the scientific and technical working teams of the organization over the course of 4 days to discuss regulatory developments in medical devices and technological developments. The meeting was attended by a number of leading speakers, experts, specialists, interested parties, relevant factories and regulatory authorities. The meeting aimed at creating an environment of legislative homogeneity and convergence, developing systems and legislation under international best practices, and helping emerging countries build their oversight systems and benefit from the various experiences of the GHWP’s members.
