SULTANATE TO HOST AHWP ANNUAL MEET FROM NOVEMBER 11
The Sultanate will host the 24th Asian Harmonisation Working Party (AHWP) annual meeting accompanied by a Medical Device Exhibition at Grand Millennium Hotel, in Muscat from November 11 to 14.
Organised by the Ministry of Health (MOH), represented by the DirectorateGeneral of Pharmaceutical Affairs and Drug Control (PADC), around 250
300 participants including regulators from more than 30 countries along with representatives from IMDRF (International Medical Device
Regulators Forum), ISO (International Standards Organisation), APEC (Asia Pacific Economic Cooperation), World Health Organisation, APACmed (Asia Pacific Medical Technology Association) and others are expected to attend the event. More than 60 expert speakers will be addressing the meeting that will have a full day of capacity building sessions.
According to Dr Mohammed Al Rubaie, Director General of Pharmaceutical Affairs and Drug Control at the Ministry of Health, the meeting, which will be attended by health experts will raise the awareness level among health staff on the importance of monitoring the problems associated with the usage of medical devices, supplies and products. It will shed the light on the latest developments on medical device guidance documents through the updates from the AHWP 9 Technical working groups covering Pre-marketing of General Medical devices, In Vitro Diagnostics and Software as a Medical Device, Post-Market, Clinical Evidence for Performance and Safety, Quality Management System: Audit, Assessment, Operation & Implementation, Medical Device Standards, Unique Device Identification and Nomenclature.”
The objective of the event is to ensure the advancement of global healthcare, creating a link between the leaders and players of the healthcare industry, building capacity of both regulators and industry to foster innovative regulatory solutions for medical technology advancements, besides providing an in-depth knowledge on the latest medical innovations. The event will also provide a platform to share the latest in the medical device regulations, discuss current issues in the medical device sector and promote international harmonisation and convergence and promote research into quality and safety improvement and networking opportunity amongst leaders and key stakeholders of the healthcare industry. The organising committee comprises among others Ali M. Al Dalaan, Vice President – Medical Device Sector of Saudi Food and Drug Authority as AHWP Chair, Mohammed Al Rubaie, DGPA & DC, Ministry of Health- Oman, Faiza Al Zadjali, DGPA & DC, Ministry of Health-Oman and Gao Guobiao, AHWP Vice Chair.
The Asian Harmonisation Working
Party (AHWP) was established as a non-profit organisation in 1996. Its goals are to study and recommend ways to harmonise medical device regulations in the Asian and other regions and to work in coordination with the International Medical Device Regulators Forum ( IMDRF) and other related international organisations aiming at establishing harmonised requirements, procedures and standards. The Working Party is a group of experts from the medical device regulatory authorities and the medical device industry. Membership is open to those representatives from the Asian and other regions that support the above stated goals. AHWP has more than 30 member economies including Brunei Darussalam, Cambodia, Chile, Chinese Taipei, Hong Kong SAR, China, India, Indonesia, Jordan, Kazakhstan, Bahrain, Saudi Arabia, Korea, Laos, Malaysia, Mongolia, Myanmar, Pakistan, Philippines, Kenya, Singapore, South Africa, Kuwait, Sultanate of Oman, Tanzania, Thailand, United Arab Emirates, Vietnam, Yemen and Zimbabwe.