Certification Introduction
Market access for medical devices in Saudi Arabia is uniformly regulated by the Saudi Food and Drug Authority (SFDA). Medical devices placed on the market or exported to Saudi Arabia must obtain the Medical Device Marketing Authorization (MDMA) issued by SFDA. This is a mandatory market access requirement, and differentiated registration management is implemented based on product risk levels.
Laws and Regulations
The core regulatory basis is the Medical Device Regulation (MDR) issued by SFDA, and MDS-REQ 1 Requirements for Marketing Authorization of Medical Devices. All registration applications must be submitted through SFDA's official GHAD online electronic service system, and applicants must comply with Saudi post-market supervision, adverse event reporting and other subsequent compliance requirements.
Technical Requirements
- The quality management system shall comply with GSO ISO 13485 or equivalent standards recognized by SFDA
- Products are classified into Class I (low risk), Class IIa/IIb (medium risk), and Class III (high risk) by risk level, with different review requirements for different categories
- Complete technical documentation must be submitted, including product specification description, design verification data, risk management report, and safety performance assessment. Medium and high-risk products need to provide clinical evaluation reports or clinical trial data, and active medical devices additionally require electrical safety and electromagnetic compatibility (EMC) test reports
- Non-Saudi local manufacturers must appoint a Saudi local authorized representative that meets SFDA requirements to be responsible for communication and post-market affairs
Certification Process
- Determine product risk classification and appoint a qualified Saudi local authorized representative that meets requirements
- Prepare the full set of application materials corresponding to the product category, including technical documents, quality management system certificates, test reports, etc.
- Complete account registration on SFDA's official GHAD system, submit the registration application and pay the corresponding registration fee
- SFDA conducts technical document review, and may require supplementary materials, samples or on-site production audit as appropriate
- Obtain the MDMA certificate after passing the review, the certificate needs to be renewed in accordance with SFDA requirements, and continuous compliance with regulatory requirements is required after market launch
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