SFDA Participates in the annual Asian Harmonization Organization Conference, held in Philippines

11/24/2016
 


SFDA Participates in the annual gathering and conference of the Asian Harmonization Organization AHWP, held in Philippines.

The chairman of the scientific & technical groups of the organization, the Executive Director of Radiological Health Department at SFDA, Engineer Ali Al Dalaan launched the associated activities, workshops and training of the annual gathering and conference wherein the scientific & technical groups and a number of international experts are participating.

Engineer Isam Al Mohandis, the Executive Director of Surveillance and Biometrics Department at SFDA participated as chairman of the First Task Force of AHWP concerning pre-marketing, together with Engineer Abdullah Al Raheeed, the Executive Director of Inspection & Enforcement Department at SFDA as chairman of the Sixth Task Force of AHWP concerning Quality Management System.

The annual AHWP conference includes submission of clinical studies, pre-marketing legislation requirements, classification of medical devices and products, post-marketing requirements of the medical devices and products, e.g., monitoring the performance and efficiency of the medical device & product and its compliance with its intended purpose for use in medical diagnosis and treatment, in addition to conformity verification of medical devices & products factories and the quality programs pertaining to the design, manufacturing and monitoring the efficiency of medical devices & products after manufacturing and operation processes and adoption of quality program on them prior to granting authorization to enter the markets.

The conference reviews presentations of member and non-member states experiences and legislations e.g, KSA, China, Korea, Kazakhstan, Japan, Vietnam, India and Democratic Republic of Laos and Philippines in addition to presentation of EU Medical Devices Legislation and regulation.

Participants in the annual conference of the Asian Harmonization Organization AHWP included all member states viz: KSA, China, India, Korea, Singapore, Indonesia, Malaysia, Philippines, Kazakhstan, Vietnam and a number of countries and similar  regulators from USA,EU, WHO, Imdrf harmonization group and ISO