How to register a medical device or IVD in Saudi Arabia: SFDA registration process explained
Getting started with SFDA registration
If you plan to market a medical device or in vitro diagnostic (IVD) in Saudi Arabia, you must comply with the regulatory process established by the Saudi Food and Drug Authority (SFDA).
In this article, we provide a complete, up-to-date, and practical guide to help you prepare for entry into the Saudi market, whether you’re a first-time applicant or looking to expand your portfolio.
Main steps for SFDA registration
1. Device classification
In Saudi Arabia, medical devices and IVDs are classified into four risk-based categories:
A, B, C, and D.
The class depends on factors such as invasiveness, duration of use, type of analysis, or contact with the human body.
These risk classes are based on the GHTF model and do not directly match the European CE classes, so a specific classification must be carried out according to SFDA guidelines.
2. Appointment of a local authorized representative (LAR)
If the manufacturer does not have a legal presence in Saudi Arabia, it is mandatory to appoint a local authorized representative (LAR).
The LAR is responsible for:
- creating and managing the account in the Ghad system
- registering the manufacturer and its devices
- communicating with the SFDA
- handling post-market responsibilities on behalf of the manufacturer
3. Registration in the Ghad system
The Ghad system is the official online portal of the SFDA. All regulatory submissions must be processed through this platform.
The LAR will register:
- manufacturer and production site information
- device data and classification
- required documentation
Once the information is validated, you will receive confirmation of successful registration.
4. Preparation of the technical documentation
Each device must be supported by a comprehensive technical file, which typically includes:
- ISO 13485 certificate, CE marking, or other approvals (e.g. FDA)
- technical dossier/design file
- labels and instructions for use (IFU) in both Arabic and English
- clinical or performance evaluation data
- risk management documentation
Requirements vary depending on the risk class and type of device.
5. MDMA (medical device marketing authorization)
For class B, C, and D devices, you must apply for the medical device marketing authorization (MDMA).
The SFDA will review your technical documentation and, if compliant, grant authorization to place the product on the Saudi market.
For class A devices, a simplified process applies: registration via listing only.
6. Establishment registration
All manufacturing sites involved in the production, sterilization, or packaging of the device must be registered with the SFDA. This step is essential for ensuring full regulatory traceability.
7. Labeling and UDI requirements
Each device must meet SFDA labeling requirements, including:
- Arabic-language content on labels and IFUs
- a valid UDI (unique device identification) code in accordance with the Saudi UDI framework
UDI is essential for traceability and post-market monitoring.
8. Post-market obligations
After obtaining marketing authorization, manufacturers must comply with SFDA post-market surveillance requirements, which may include:
- incident and adverse event reporting
- complaint handling procedures
- updates to device information in the Ghad system
- periodic safety and performance reports, if required
Failure to meet these obligations may result in suspension or withdrawal of market authorization.
The SFDA registration process has its own structure and technical requirements. Understanding each step in advance , from classification to post-market responsibilities, will help you reduce regulatory risk and ensure a smoother market entry.
Need support with the SFDA process?
We can assist you in every phase, from strategy to execution. Contact us for tailored regulatory guidance.
