Saudi Food and Drug Authority
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Saudi Arabia Medical Device Regulations
The Saudi Food and Drug Authority (SFDA) oversees the regulatory submission and approval process for medical devices in Saudi Arabia. The governing framework is the Medical Devices and Supplies Regulation (Council of Ministers Resolution No. 337), commonly called the Medical Devices Law. This regulation, which replaces the previous Medical Devices Interim Regulation, establishes precise requirements for registering and approving medical devices in the country.
The Implementing Regulation of the Medical Devices Law was introduced in 2021 to strengthen this framework. This regulation provides detailed guidance on compliance, including the content required for a device’s Technical File, ensuring manufacturers comprehensively understand the documentation and procedural expectations.
Alignment with Global Standards
The Medical Devices Law and its Implementing Regulation closely mirror the European Union’s Medical Devices Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR). This alignment includes similarities in:
- The approach to reviewing submissions.
- The required set of documents for technical documentation.
Manufacturers familiar with EU regulatory processes will find these similarities beneficial, as they can leverage their existing documentation and compliance strategies to meet SFDA requirements.
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Medical Device Classification in Saudi Arabia
Risk-based classification
Saudi Arabia uses a risk-based classification system for medical devices closely aligned with international standards. Devices are categorized based on the risk they pose to patients and users. This system ensures proportional regulatory scrutiny and is divided into the following classes:
General Medical Devices
- 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:
- 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
Medical Device Approval Process in Saudi Arabia
To market a medical device in Saudi Arabia, manufacturers must obtain approval from the SFDA through the Medical Devices Marketing Authorization (MDMA) process. The steps involved are as follows:
- Compliance with Essential Principles
Manufacturers must ensure that devices comply with the SFDA's Essential Principles of Safety and Performance, covering design, manufacturing, and intended use.
- Preparation of Technical Documentation
Manufacturers must develop and maintain detailed technical documentation demonstrating compliance with the Essential Principles. This includes:
- Risk assessments.
- Performance and safety testing results.
- Clinical evaluation reports (if applicable).
- Device labeling and instructions for use (IFUs).
- Quality Management System (QMS)
A robust QMS, compliant with ISO 13485:2016 or an equivalent standard, is required. The QMS ensures that all processes, from design to post-market surveillance, meet regulatory requirements.
- Application Submission
Manufacturers or their Local Authorized Representative (LAR) must submit an MDMA application electronically via the SFDA’s E-Services portal.
- Payment and Document Review
After submission, the SFDA requires payment of applicable fees. The authority reviews the submitted documentation for compliance, technical accuracy, and completeness.
- Issuance of MDMA
Upon satisfactory review, the SFDA issues the Medical Devices Marketing Authorization (MDMA), granting the manufacturer the right to market the device in Saudi Arabia.