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Is annual renewal required for Class C medical device registration in Saudi Arabia?
Release time：2025-07-14 15:05:14 The author: source:
No, annual renewal is not required for Class C medical device registration in Saudi Arabia. Instead, the registration (Medical Device Marketing Authorization, MDMA) for Class C devices is valid for 3 years from the date of issuance.

No, annual renewal is not required for Class C medical device registration in Saudi Arabia. Instead, the registration (Medical Device Marketing Authorization, MDMA) for Class C devices is valid for 3 years from the date of issuance.

Key Points on Renewal for Class C Medical Devices:

  • Renewal Frequency:
    The MDMA certificate must be renewed every 3 years before it expires to maintain legal market access.

  • Renewal Process:
    Renewal requires submission of updated technical documentation, post-market surveillance data, proof of ongoing compliance, and payment of renewal fees via the SFDA GHAD portal.

  • Establishment License (EL):
    Unlike the device registration, the Establishment License for the manufacturer and the Authorized Representative must be renewed annually.

  • Consequences of Non-Renewal:
    Failure to renew the MDMA registration on time can lead to suspension or cancellation of the device’s registration, prohibiting marketing and sales in Saudi Arabia.

If you want, I can help you prepare for the renewal process or clarify differences between device registration renewal and establishment license renewal.

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


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