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How long does it take to obtain Class C medical device registration in Saudi Arabia?
Release time：2025-07-14 15:05:44 The author: source:
Obtaining Class C medical device registration in Saudi Arabia typically takes 3 to 6 months from the date you submit a complete and compliant application to the Saudi Food and Drug Authority (SFDA).

Obtaining Class C medical device registration in Saudi Arabia typically takes 3 to 6 months from the date you submit a complete and compliant application to the Saudi Food and Drug Authority (SFDA).

Timeline Overview:

StageEstimated Duration
Preparation of application4 to 6 weeks (varies)
Establishment License approval2 to 4 weeks
SFDA Technical Review3 to 6 months
Responses to SFDA queries2 to 4 weeks per query round
Issuance of Registration CertificateImmediately after approval

Notes:

  • The total time depends on how quickly you prepare your documents and respond to any SFDA requests.

  • Prior certifications (like CE or FDA) may help streamline the review.

  • Delays usually arise from incomplete submissions or slow responses to queries.

If you want, I can assist with a tailored timeline based on your specific situation or help review your documentation to reduce approval time.

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Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn


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