Handling Class C medical device registration in Saudi Arabia involves a clear sequence of steps governed by the Saudi Food and Drug Authority (SFDA). Class C devices are medium-to-high risk medical devices, so the registration process is detailed and requires comprehensive technical documentation, proper local representation, and compliance with SFDA regulations.

Here's a straightforward guide on how to handle Class C medical device registration in Saudi Arabia:

Step-by-Step Guide to Registering Class C Medical Devices in Saudi Arabia

1. Confirm Device Classification

• Verify that your medical device is indeed Class C according to SFDA’s classification criteria. This classification impacts the requirements and documentation you need to submit.

2. Appoint a Saudi Authorized Representative (AR)

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

• The AR will be your local regulatory liaison, responsible for communication with SFDA and managing post-market obligations.

• Ensure the AR holds a valid Establishment License (EL).

3. Obtain Establishment Licenses (EL)

• Both the manufacturer and AR must have valid Establishment Licenses issued by the SFDA.

• EL applications are submitted through the SFDA’s GHAD platform.

• EL approval is required before device registration submission.

4. Prepare Comprehensive Technical Documentation

• Compile all required documentation, including:

  • Device description and classification justification

  • Risk management report (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 other international approvals (e.g., CE, FDA)

• Ensure compliance with SFDA’s Essential Principles of safety and performance.

5. Register and Submit Application on GHAD System

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

• Submit your Class C device registration application online with all supporting documents.

• Pay the required fees (generally SAR 20,000–40,000 depending on the device).

6. Respond to SFDA Technical Review Queries

• The SFDA will review your submission, which typically takes 3 to 6 months.

• They may request clarifications or additional documents.

• Provide timely responses to avoid delays.

7. Receive Medical Device Marketing Authorization (MDMA)

• After successful review, SFDA issues the MDMA certificate.

• The certificate is valid for 3 years and available digitally via the GHAD portal.

8. Comply with Post-Market Obligations

• Implement post-market surveillance.

• Report adverse events and maintain compliance.

• Prepare for renewal well before the certificate expires.

Key Tips

• Accurate and complete technical documentation is essential to avoid delays.

• Use a reliable Authorized Representative experienced with SFDA procedures.

• Stay updated on SFDA regulatory changes.

• Plan ahead for renewal and post-market surveillance requirements.

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