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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, effectiveness 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 director’s decision no. (1-8-1429) issued on 27/12/2008. This regulation will apply until the medical devices comprehensive law is approved.

As a result the SFDA launched a comprehensive marketing authorisation program intended to safeguard public health as it relates to medical devices. The program comprises two major steps.

  • Establish an overall profile of the medical devices presently on the Kingdom of Saudi Arabia (KSA) market.
  • Develop, adopt and apply a Medical Devices Interim Regulation, complemented by Implementing Rules, thereby ensuring legal certainty that only medical devices that have been authorised by one of the Founding Members of the Global Harmonization Task Force (GHTF) have access to the KSA market.

In fulfillment of Medical Devices Interim Regulation (chapter Two & chapter Six) in addition to Implementing Rule on the Validation of Documents to be provided to the SFDA by Manufacturers for Marketing Authorisation (MDS-IR6), The SFDA is pleased to lunch Medical Devices marketing Authorization System (MDMA).

MDMA is an electronic system aims to authorize medical devices after they comply with the Medical Devices Interim Regulation (MDIR) and in particular to the implementing rule MDS-IR6 for Medical Device Marketing Authorisation (MDMA). The system allows local manufacturers and overseas manufacturers authorized representatives to apply electronically for medical devices marketing authorization which permits relevant medical devices to be placed on the market of the Kingdom of Saudi Arabia, when satisfied that the applicant has provided all the required information for market authorization.

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