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SFDA Head: “Our E-Programs and Control Regulations eased our Processes and Tightened Control”



 The CEO of SFDA, Dr. Mohammed bin Abdul Rahman Almishal, confirmed that SFDA continues to implement its programs and development of its control regulations, which will help to protect the country and the citizen and residents from entry of any food or drugs or Medical devices to the Saudi markets, pointing out that SFDA electronic programs facilitated procedures, ensure accuracy and tightened its control over all products coming across the points of entry of the Kingdom.

Almishal said :”The international reputation of the Kingdoms in the field of applied control regulations in clearance and monitoring of medical devices has urged WHO to choose the Kingdom for holding its inter-country meeting on designing and implementing a regulatory program for medical devices. He added, “The conference held in Riyadh last week won praise and admiration of the representatives of 22 countries who came to view SFDA advancement in the field of medical devices & products control.

He added, “SFDA continuously review the international regulations in order to update its own regulations. WHO decided to hold the meeting in Riyadh under SFDA sponsorship as a result of SFDA progress in its control plans and we are pleased to present our experience in the field of medical devices & products control to the representatives of those countries to transfer it to their own countries.

To this extent, Dr. Adham Ismail, Middle East Regional Manager for medical devices & products- WHO, confirmed that choosing SFDA for sponsoring this meeting in Riyadh came out as a result of comprehensive survey of all the member countries in the region with respect to application of medical devices & products regulations in those countries. Dr. Ismail said: “We did not find any better country than Saudi Arabia, represented by SFDA, which is a leader and member of international alliances for regulation of medical devices world-wide, as it is the only one among 22 countries in the region that owns an advanced program in this field and therefore SFDA was selected to sponsor this meeting in the Kingdom of Saudi Arabia”.

SFDA was able during the last three years to innovate and implement efficient electronic systems that saved suppliers time and effort and made control possible through electronic systems. This allowed organizations to practice their activities without the need to visit SFDA premises. An example of these systems is the National Register for Medical Devices & Products (MNDR), the Medical Devices Establishments Licensing (MDEL)- which can be used for annual renewal of the License in addition to Authorized Representative Licensing (AR) System which is part of the (MDEL), Medical Device Marketing Authorization (MDMA) System in addition to the National Center for Medical Devices Reports (MCMDR) for practitioners and the public to electronically report any adverse event associated with medical devices.

SFDA Medical Devices & Products Sector helped to protect the Saudi Market from entry of fake or fraudulent. SFDA developed regulations for control of medical devices and products to ensure safety and efficiency of these devices that exceed 200 thousand medical devices and products registered in the Saudi Market= the second largest market in the Middle East & North Africa (MENA) region with 5022 registered factories.

SFDA built a network of advanced laboratories equipped with modern devices and qualified staff for inspection of all food samples received from control of imported food department, points of entry at the borders, local markets, surveillance and crisis management center, In addition, SFDA built a number of important centers that provide support service, e.g., poisons research center, GCC Rapid Alarm Center, monitory of food contamination center and food & feed risk assessment unit.

The electronic program for registration of imported food has reduced the procedures period for releasing food products from three days to few hours and facilitated control and audit procedures steps.

The program provides product tracking service. SFDA also built several and detailed of data bases to reflect the size of available goods in the local market and the imported goods and prevent compromising consumer health by those who try to enter violating food substances that are not good for use in violation to food specifications. The program also eliminate specification manipulation margin and allows consumers to track the validity of their food and how does it fit his health. The program also tightens SFDA control over imported food through the authorized points of entry.

In addition to this program, SFDA established GCC Rapid Alarm System for Food, Feed Control electronic services and local markets control electronic services.

SFDA has also put in place stringent control systems for drug importation and clearance in order to ensure safety of consumers and safety and efficacy of drug. Example of these systems is the Product Classification System, Electronic System for Registration of Cosmetics (ECOSMA), Products and Product Lot importation and clearance system (FASEH), Saudi Drug Registration System (SDR), the National Pharmaceutical Establishments Registration System, Drug prices data base for the Middle East, Saudi Pharmacovigilance System and the Narcotic Drugs Electronic System




Medical Devices