Applying for Class C medical device registration in Saudi Arabia involves a structured process regulated by the Saudi Food and Drug Authority (SFDA). Here are the step-by-step procedures to follow:

Step 1: Confirm Device Classification

• Ensure your medical device is correctly classified as Class C based on SFDA’s classification rules.

Step 2: Appoint a Saudi Authorized Representative (AR)

• If you are a foreign manufacturer, appoint a Saudi-based Authorized Representative.

• The AR must hold a valid Establishment License (EL).

Step 3: Obtain Establishment Licenses (EL)

• Both the manufacturer and AR need to have valid ELs issued by SFDA.

• Apply for these licenses via the SFDA’s GHAD portal.

Step 4: Prepare Technical Documentation

• Compile a complete technical file including:

  • Device description and intended use

  • Risk management file (ISO 14971)

  • Clinical evaluation report (CER)

  • Declaration of conformity

  • Quality management system certificate (ISO 13485)

  • Labeling and instructions for use in Arabic and English

  • Certificates of Free Sale or approvals from recognized authorities (CE, FDA, etc.)

Step 5: Register on the GHAD Portal

• Register your company and AR on the SFDA’s GHAD system: https://ghad.sfda.gov.sa.

Step 6: Submit the Registration Application

• Upload your application and technical documentation through the GHAD portal.

• Pay the applicable registration fees (generally SAR 20,000–40,000).

Step 7: SFDA Review

• SFDA performs a technical review of the application.

• They may request additional information or clarifications.

• Respond promptly to any queries to avoid delays.

Step 8: Receive Medical Device Marketing Authorization (MDMA)

• Upon approval, SFDA issues the MDMA certificate, valid for 3 years.

Step 9: Post-Registration Compliance

• Implement post-market surveillance and adverse event reporting.

• Prepare for renewal before the certificate expires.

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