SEOUL: Representing the Saudi side are ranking SFDA officials, including Vice Executive for Medical Devices Nazeeh Alothmany, Executive Director of Registration and Licensing Abdullah Salem Al-Dobaib, and Executive Director of Surveillance and Biometrics Essam M. Al Mohandis.
They will also visit Osong Medical Innovation Foundation, a clinical trial examination institute for medical devices, on Thursday, and a local medical device manufacturing company Ilooda on Friday, the Korean ministry said.
The cooperative efforts are a follow-up measure to a meeting that took place last November with SFDA Minister Hisham S. Aljadhey to strengthen cooperation in the food and drug sector.
The officials of the two countries will discuss cooperative tasks between the two countries and Korean regulations. Korean officials will also explain the country’s medical device system, including the medical device approval process, Good Manufacturing Process system, clinical trial level, and safety monitoring system according to requests by the Saudi Arabian authorities, it said.
“We will, in particular, discuss how to get MFDS-approved medical devices an SFDA-approval for sales and distribution without submitting separate documents for approval,” the ministry said.
To obtain SFDA approval, Korean companies must submit a document of approval from the U.S., Europe, Japan, Canada or Australia.