Summary:
The 28th Global Harmonization Working Party (GHWP) Annual Meeting took place from December 9 to 12, 2024, at the Kuala Lumpur Convention Centre in Malaysia. The meeting commenced with an inaugural ceremony led by YB Datuk Seri Dr. Dzulkefly Ahmad, Malaysia’s Minister of Health, chaired by Dr. Xu Jinghe. The meeting welcomed over 350 participants and included the adoption of the agenda and minutes from the previous meeting. Reports highlighted GHWP’s progress over the past year, including strategic objectives and partnerships with international organizations. Notable updates were shared by WHO and IMDRF regarding medical devices. Several organizations like AMDF, DITTA, and GS1 provided insights into their initiatives. Country-specific updates were presented by representatives from Malaysia, Egypt, Indonesia, Japan, Saudi Arabia, China, and Korea, covering regulatory frameworks and future trends. Significant endorsements were made for leadership roles and recommended amendments to GHWP’s governing documents. The next GHWP gathering is planned in 2025. Our Vice President, Ong Yean Ting was elected as Co-chair for WG5 Clinical Evidence and appointed as MMDA Representative as panelist.
Key Highlights:
- Official Opening Ceremony: The meeting commenced with an inaugural ceremony led by YB Datuk Seri Dr. Dzulkefly Ahmad, Malaysia’s Minister of Health, emphasizing the importance of shaping the future of medical device regulation collaboratively.
- Endorsement of Key Regulatory Documents with several proposed documents were reviewed and endorsed during the meeting, aim documents aim to harmonize global medical device regulations and enhance industry practices:
- UDI Data Elements
- Creation and Placement of Unique Device Identifier
- Guidelines on Development of GHWP Documents
- Guidance Document for Medical Device Organizations on Product Localization
- Comparison Study of ISO 13485 vs. QMS Requirements in GHWP Member Countries
- Software as a Medical Device (SaMD) PreMarket Submission Requirements
- Change Management to Registered Medical Devices
- Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) Devices
- Presentations and Discussions: The meeting featured a series of presentations covering various topics, these sessions provided insights into current trends and challenges in medical device regulation including:
- Regulatory excellence and competency frameworks
- Digital labeling and electronic instructions for use (eIFU)
- Quality Management System (QMS) implementation and audits
- RealWorld Evidence (RWE) in regulatory submissions
- Software as a Medical Device (SaMD) regulatory requirements
- Networking Opportunities: The event facilitated networking among regulators, industry professionals, and stakeholders, promoting collaboration and knowledge sharing in the field of medical device regulation.
