The time frame for applying and obtaining Class C medical device registration in Saudi Arabia typically spans from 3 to 6 months for the core SFDA review, with the entire process (including preparation) often taking 5 to 8 months.

⏳ Time Frame for Class C Medical Device Registration

🔍 What Does the SFDA Review Process Include?

1. Administrative Check

   • Verification of application completeness.

   • Validation of company and AR registration status.

   • Confirmation of payment of fees.

2. Technical Review

   • Detailed assessment of the technical documentation:

     • Device description and classification justification.

     • Risk management file (ISO 14971).

     • Clinical evaluation report (CER).

     • Quality management system certification (ISO 13485).

     • Labeling and Instructions for Use (IFU), including Arabic translation.

     • Certificates of prior regulatory approvals (CE, FDA, etc.).

   • Assessment of compliance with SFDA Essential Principles of safety and performance.

3. Queries and Clarifications

   • SFDA may raise questions or request additional documentation.

   • Applicant must respond within specified timelines to avoid delays.

4. Decision

   • Upon satisfactory review, SFDA grants the Medical Device Marketing Authorization (MDMA).

   • The certificate is issued electronically via the GHAD portal.

Additional Notes

• Prior international certifications (CE, FDA) may help accelerate review via an abridged pathway.

• Delays often occur due to incomplete documentation or slow responses to SFDA queries.

• Preparing a thorough, compliant application upfront can significantly shorten the timeline.

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