SFDA Participates in the Asian Harmonization Task Force Meeting
2015-11-30
SFDA, represented by the Medical Devices & Products Sector, participated in the 20th. periodic meeting of AHTS countries and the 19th. Technical & Scientific Task Forces meeting held during the period 2nd. & 6th. of this month of November.
The meetings discussed topics related to regulation and monitoring of the Medical Devices & Products in addition to approval of the relevant regulations.
H.E. The Executive Director of Radiation Health Department of SFDA, Head of the Scientific & Technical Task Forces in the Organization, Engineer Ali Al Dalaan opened the activities of the meeting in the first day that included workshops about the regulations and requirements for new members who are interested in the development of legislations of monitoring medical devices and products in their local markets. The workshops reviewed requirements for the registration of manufacturers, importers and distributors of medical devices and products, in addition to quality regulations ISO 13458 and means of utilization of conformity assessment bodies and their role in the technical assessment of medical devices.
The program also included a training workshop on clinical studies regulations to ensure the validity of the medical device and product with respect to technical requirements, i.e., design, performance and assessment of clinical and technical standards resulting resulting from the work of the medical team either in diagnosis or treatment, and hence determine to give license to the device or not.
The program also included scientific discussions about medical devices software systems involved in analysis and diagnosis, in addition to medical devices and products quality system for distributors and suppliers only besides workshops about auditing and assessment of medical devices and products factories, suppliers and distributors.
Some countries which are not members of the organization such as USA, EU, Japan, Kazakhstan provided presentation about the latest updates in the field of regulation of medical devices and products. Also other presentations were delivered by member countries such as China and Thailand.
In the last two days of the event, the technical and scientific task force, headed by Engineer Ali Al Dalaan, held meetings wherein brief presentations were delivered by the participating teams about their major existing work. Engineer Isam Al Mohandis- head of the first task force concerned with medical devices & products pre-marketing requirements and Engineer Abdullah Al Rasheed head of the sixth task force concerned with inspection regulations participated from SFDA by giving presentation on the performance and achievements of the task force. At the end of the gathering voting was made on approval of 11 scientific and legislation studies of medical devices and products, in addition, Kazakhstan and Cambodia membership in the organization was approved.
It worth mentioning that the periodical meeting of the organization witnessed participation of several international bodies and organizations such as World Health Organization (WHO) and International Medical Devices Regulation Forum (IMDRF)
