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Your Global Medical Device Compliance Partner


Saudi Arabia Regulatory Strategy 

Medical devices are regulated by the Saudi FDA. Under the SFDA’s requirements, medical device companies must appoint an authorized representative and obtain market authorization from the SFDA 

The SFDA bases its market authorization on prior approval in a reference jurisdiction (Australia, Canada, Europe, Japan or the United States); registration applications are reviewed by third-party Conformance Assessment Bodies in Saudi Arabia.

Let RS assist you in evaluating the Saudi Arabian medical device regulatory framework as it applies to your device(s)

Through our global network of in-house consultants, industry contacts and regulatory sources, RS can provide in-depth analysis of medical device markets including Saudi Arabia. Our Global Regulatory Overview report service on the Saudi Arabian medical device market covers the following:

  • SFDA Regulatory Background

  • Product Assessment

  • In-Country Representation in Saudi Arabia

  • Medical Device Registration Requirements

  • Device grouping strategy (for systems, families, etc.)

  • Costs and Timelines

  • Labeling and Language Requirements

  • Regulatory Roadmap for Saudi Arabia

Please contact us for more information about our Regulatory Overview Report for Saudi Arabia.

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