18/09/2013

Saudi Food & Drug Authority

Saudi Food and Drug Authority

Saudi Arabia's medical device market is the 2nd largest in the Middle East and North Africa (17%), after Turkey, with about 11% annual increase. However, annual percapita spending is US$62, which is the third highest in the region. Medical device spending in Saudi Arabia as a percentage of GDP and healthcare expenditure is 0.3% and 6.3%, respectively. The few medical device manufacturers in Saudi Arabia focus on low-end consumables or act as agents for foreign firms. High-end products are generally imported from the US, China, South Korea and Western European multinationals.


With this market size, the Saudi Food and Drug Authority (SFDA) comes to play an important role in ensuring safety, quality and effectiveness of medical devices throughout their life cycle (pre-market, on-market and post-market).


The Medical Devices Sector (MDS) of the SFDA specifies the overall framework of the regulatory approach for the Saudi marketing authorization and the post-marketing surveillance of medical devices. It places responsibilities on medical devices importers, distributors, local manufacturers and authorized representatives (AR) of overseas manufacturers in KSA.


The main objectives of the MDS at SFDA are to protect and maintain public health within the Kingdom of Saudi Arabia by implementation of provisions ensuring a high level of safety and health protection of patients, users and third parties with regard to the use of medical devices and to mandate measures, and allocate responsibilities, to ensure that medical devices placed on the market and/or put into service within the KSA comply with all relevant requirements and provisions of the Medical devices Interim Regulation and its implementing rules.


SFDA participation in MEDICA 2013 represents the high commitment in delivering the right information to the right related stakeholders. Medical Devices Sector at SFDA will focus on issues related to requirements and responsibilities of AR of foreign manufacturers and market authorization of medical devices. Most of the medical devices placed on the Saudi Market are imported from all over the world including. So, participating in MEDICA 2013 is a great opportunity to meet the overseas manufacturers and share with them the Saudi Regulation Scheme for medical devices.