1. Appoint a Saudi Authorized Representative (AR)

• Non-Saudi manufacturers must appoint an Authorized Representative (AR) based in Saudi Arabia.
• The AR must be registered with the SFDA and will be responsible for submitting the device registration application, as well as post-market surveillance and reporting.

2. Obtain an Establishment License

• The Authorized Representative must obtain a Medical Device Establishment License (MDEL) from the SFDA. This license is required for companies wishing to import, distribute, or market medical devices in Saudi Arabia.

3. Device Classification

• Confirm the classification of your medical device as Class C using the Medical Device Classification system available on the SFDA website. The classification determines the level of review required.

4. Prepare Required Documents

You will need to gather the following documentation to support your application:

• Technical File or Dossier: Include detailed information about the device, such as its design, materials, and intended use.
• Clinical Evaluation and Evidence: Proof that the device is safe and performs as intended, with clinical data to back this.
• Quality Management System (QMS): Provide evidence that the manufacturer is certified to ISO 13485 (Medical Devices Quality Management System).
• Declaration of Conformity: A declaration that the device complies with relevant standards.
• Device Labeling: Labels and instructions for use, both in Arabic and English, which must be compliant with SFDA labeling regulations.
• Risk Management: Risk analysis and mitigation strategies, typically following ISO 14971 standards.
• Previous Approvals: If the device is approved or registered in other jurisdictions (e.g., CE mark in the EU, FDA approval in the USA), include these certificates.

5. Submit an Application via the GHAD Portal

• The SFDA uses the GHAD system, an online portal for medical device submissions. Through GHAD, you will create an account and submit your application for Medical Device Marketing Authorization (MDMA).
• Select the appropriate device classification and complete the online forms, uploading the required documents for review.

6. Pay Registration Fees

• SFDA charges fees for the review and registration process. These fees vary based on the classification of the device and the complexity of the application.

7. SFDA Review Process

• Once submitted, the SFDA will conduct a technical review of your application. The review includes evaluation of the device’s safety, performance, and compliance with applicable regulations.
• SFDA may request additional information during the review if there are any gaps or concerns in the submitted documents.

8. Post-Market Surveillance Plan

• For Class C devices, a post-market surveillance plan is required. This includes details on how you will monitor the device's performance and safety after it is introduced to the market, including adverse event reporting.

9. Approval and Issuance of MDMA

• Once the SFDA is satisfied with the application and the device meets all safety and regulatory requirements, they will issue a Medical Device Marketing Authorization (MDMA).
• The MDMA certificate is typically valid for 3 to 5 years, after which it must be renewed.

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