Saudi Food and Drug Authority (SFDA) was established under the Council of Ministers resolution No. (1) issued on 10/3/2003, as an independent Authority reporting to the Council of Ministers. The SFDA aims to " ensure the safety of food, safety, quality and effectiveness of drug, and the safety, quality, efficacy and performance of medical devices according to their intended purpose ". Regulating medical devices, in vitro- diagnostic devices, prescription eye glasses, contact lenses and their solutions, are among the responsibilities of SFDA in accordance with its law issued by the royal decree No.(M/6) issued on 13/2/2007.
Based on the Council of Ministers resolution No. (181) issued on 18/6/2007 that gave SFDA the right to issue regulations for medical devices registration rules and procedures, the SFDA issued a medical devices interim regulation, which was adopted by SFDA board of directors decision No. (1-8-1429) issued on 27/12/2008. This regulation will apply until the medical devices comprehensive law is approved.
The medical devices interim regulation aims to:
In fulfillment of Medical Devices Interim Regulation (chapter Five),The SFDA is pleased to lunch Medical Devices Establishment Licensing System (MDEL) For Medical Devices establishments involved in importation and/or distribution of medical devices in Saudi market.
Who Should Enroll?
Parties subjected to establishment licensing:
- Protect and maintain public health within the KSA by the
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 as
it relates to their manufacture, supply and use during their lifecycle.
- 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 provisions of the Interim Regulation.
Parties subjected to Authorized Representative licensing:
- Importer, and any authorized representative acting as importer.
- All distributors, local manufacturers and authorized representatives involved in device distribution.
Note: Healthcare facilities that importing devices for their own use only are not required to be licensed.
The purpose of MDEL:
Establishment licensing is intended to ensure that an establishment is able to:
- Any natural or legal person established within the KSA who has received a written mandate from the manufacturer to act on his behalf for specified tasks including the obligation to represent the manufacturer in its dealings with the SFDA.
Note: Only establishments with SFDA Establishment License are allowed to market Medical Devices in the Saudi Market.
- Undertake all necessary customs procedures.
- Undertake all activities required to ensure appropriate management of the medical devices it import or distribute.
- Comply with the manufacturer’s requirements for the storage, handling, transport, installation and maintenance of medical devices it imports or distributes.
- Involved in trace all medical device it imports or distributes through that part of supply chain with which it is directly involved.
- A commitment to inform the SFDA of any change occur to the information submitted.
- Ensure that an authorised representative possesses a written mandate describing the activities for which it acts on the manufacturer’s behalf and these are sufficient to ensure the proper application of the relevant provisions of the Medical Devices Interim Regulation.
- 7. Ensure that an authorised representative Has set up appropriate procedures to comply with the mandated activities.