The S.F.D.A (represented by its medical devices sector) participated in the meeting of the Asian Harmonization Working Party (AHWP) that was held in Kyoto- Japan. During the meeting, the Common Submission Dossier Template draft (CSDT) which aims to unify the requirements of submitting the medical devices to the controlling authorities among the participated countries was discussed. These requirements were set according to the Summary Technical Documentation (STED) which belongs to the Global Harmonization Task Force (GHTF). The representative of Hong Kong reviewed the training project that seeks setting a comprehensive training program for the party members regarding monitoring medical products and devices and obtaining admission from the concerned controlling authorities to license the program after studying it and commenting on it from the participated countries.
Moreover, the S.F.D.A participated in the common meeting between the (AHWP) and the (GHTF) and the agenda was reviewed. The (CSDT) which is offered by the (AHWP) was discussed and compared with the requirements of the (STED) which belongs to the (GHTF) that aims to unify the requirements of the medical devices and products before marketing them between the two groups.
During the common meeting, the issue of nominating a member of the S.F.D.A as a representative of the (AHWP) in the working group specialized in laboratory analysis (IVD) within the Studying Group 1 (SG1) which belongs to the (GHTF) was discussed.
It worth mentioning that 17 persons participated in this meeting from many countries represent the (GHTF), and they are : the US, EU, Canada, Australia and Japan. While 14 persons participated from the (AHWP) representing many countries like: Hong Kong, Korea, Malaysia, Singapore and the Kingdom of Saudi Arabia.
The S.F.D.A was represented in this meeting by his Excellency d. Saleh bin Suliaman Attayar the general manager of medical devices and products and Mr. Abdurrahman bin Saleh Algifari the head of the laboratories technology specialists.