Navigate SFDA requirements with expert support. Qserve helps medical device and IVD manufacturers achieve regulatory compliance in Saudi Arabia.
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.
Qserve services for Saudi Arabia
Global Regulatory Strategy
We guide you through the SFDA registration process, ensuring your documentation is complete, compliant, and correctly submitted.
QMS Implementation & Support
Ensure your quality system meets local regulatory expectations by aligning with SFDA-recognized standards such as ISO 13485.
Local Representation in Saudi Arabia
Appoint Qserve as your authorized local representative to meet SFDA requirements for foreign manufacturers without a local entity.
Training & Regulatory Workshops
Stay informed and confident with targeted training sessions on Saudi regulatory procedures, SFDA submissions, and QMS expectations.
Post-Market Surveillance (PMS) Compliance
Get support with adverse event reporting, field safety actions, and ongoing PMS activities in line with SFDA guidelines.
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
Regulatory timelines and fees
The SFDA has established specific timelines for the review and approval of medical devices.These timelines can vary based on the completeness of the submission and the need for any additional information or clarification from the manufacturer. These timelines are designed to ensure a rigorous yet efficient review process:
Typically, the SFDA reviews initial submissions within 30 to 60 days.
Detailed review of technical documentation can take an additional 60 to 120 days, depending on the complexity of the device.
The total time from submission to the issuance of MDMA can range from 3 to 6 months.
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. process.

Get in touch for more information about Saudi Arabia Market Access
Go-to-market strategy
The regulatory framework for medical devices in Saudi Arabia aligns closely with the European Union’s system, particularly regarding technical documentation and conformity assessment. This alignment allows manufacturers to leverage their existing EU-compliant documentation, making it easier and more efficient to meet the Saudi Food and Drug Authority (SFDA) requirements. At Qserve, we help you assess your current documentation, identify what aligns with SFDA standards, and guide you in adapting it for the Saudi market. Our streamlined approach ensures faster compliance while minimizing unnecessary effort and costs. Are you curious about how to get started? Schedule a free introductory call with our experts to discuss your needs and learn how we can help you navigate the Saudi regulatory process.
Medical devices and IVD registration
Streamlined Registration and License Holding Services in Saudi ArabiaWe provide comprehensive support for medical device registration and license holding in Saudi Arabia. When requesting a quote, please ensure an efficient process; please share details about the devices, their risk classifications, and required documents such as IFUs, DoCs, CE certificates, and QMS certificates. Devices with the same legal manufacturer, intended use, risk class, design, and manufacturing process can often be grouped under a single MDMA application. This grouping simplifies the process and saves time. Each application can include: Up to 50 products A maximum of 5 technical files. Let us help you navigate the process seamlessly. Contact us today to get started!