Saudi Food and Drug Authority
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SDFA registration medical devices
In Saudi Arabia, the regulatory submission process for medical devices is overseen by the Saudi Food and Drug Authority (SFDA). The applicable regulation is the Medical Devices and Supplies Regulation, Council of Ministers’ Resolution No. 337 (Medical Devices Law) which outlines the requirements for the registration and approval of medical devices in the country and replaced the Medical Devices Interim Regulation. The Implementing Regulation of the Law of Medical Devices was issued in 2021 and it reinforces the medical device regulatory framework set out in the Medical Devices Law and discusses the provisions of the Law in greater detail, including the required content of the Technical File.
Medical Devices Law and its Implementing Regulation show significant overlap with the requirements of the European EU MDR and EU IVDR in its approach to review but also in terms of the required set of documents being part of the technical documentation.
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Medical Device Classification in Saudi Arabia
Risk-based classification
Medical devices in Saudi Arabia are classified based on the level of risk associated with their use. The classification system mirrors international standards and is divided into four classes (class A can be further divided into 2 groups):
- Class A: Low-risk devices (e.g., non-sterile, non-measuring instruments)
- Class A: Low to medium risk devices (e.g., supplied sterile, incorporating a measuring function or reusable surgical instruments)
- Class B: Low to medium risk devices
- Class C: Medium to high-risk devices
- Class D: High-risk devices
IVD Medical Devices are classified as follows:
- Class A: Low Individual Risk and Low Public Health Risk
- Class B: Moderate Individual Risk and/or Low Public Health Risk
- Class C: High Individual Risk and/or Moderate Public Health Risk
- Class D: High Individual Risk and High Public Health Risk
This classification helps in determining the regulatory requirements and the level of scrutiny a device must undergo before it can be marketed in Saudi Arabia.
Medical Device Approval Saudi Arabia
SFDA registration medical devices
To market a medical device in Saudi Arabia, manufacturers must obtain approval from the SFDA. The approval process involves several steps:
- Compliance with Essential Principles: Devices must comply with the Essential Principles of Safety and Performance specified by the SFDA.
- Technical Documentation: Preparation and maintenance of comprehensive technical documentation are required to demonstrate compliance with these principles.
- Quality Management System: Manufacturers must establish and maintain a Quality Management System (QMS) in accordance with ISO 13485:2016 or an equivalent standard.
- Application Submission: Applications for Medical Devices Marketing Authorization (MDMA) must be submitted electronically through the SFDA's E-Services portal.
- Fees and Review: Payment of applicable fees and review of submitted documentation by the SFDA.
- Issuance of MDMA: Upon satisfactory review, the SFDA issues the MDMA, allowing the device to be marketed in Saudi Arabia.