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Medical Device Regulations Saudi Arabia

Navigate SFDA requirements with expert support. Qserve helps medical device and IVD manufacturers achieve regulatory compliance in Saudi Arabia.

Saudi Food and Drug Authority

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:

  1. The approach to reviewing submissions.
  2. 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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Services

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.

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

Timelines and fees

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:

Initial Submission Review

Typically, the SFDA reviews initial submissions within 30 to 60 days.

Technical Documentation Review

Detailed review of technical documentation can take an additional 60 to 120 days, depending on the complexity of the device.

Approval and Issuance of MDMA

The total time from submission to the issuance of MDMA can range from 3 to 6 months.

Approval Process

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:

  1. 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.
  2. Preparation of Technical Documentation
    Manufacturers must develop and maintain detailed technical documentation demonstrating compliance with the Essential Principles. This includes:
    1. Risk assessments.
    2. Performance and safety testing results.
    3. Clinical evaluation reports (if applicable).
    4. Device labeling and instructions for use (IFUs).
  3. 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.
  4. Application Submission
    Manufacturers or their Local Authorized Representative (LAR) must submit an MDMA application electronically via the SFDA’s E-Services portal.
  5. 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.
  6. 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.
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Representation for foreign manufacturers 
Get in touch for more information about Saudi Arabia Market Access
strategy
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.

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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!

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