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Is annual renewal required for Class D medical device MDACS registration in Hong Kong?
Release time：2025-07-08 15:49:40 The author: source:
No, annual renewal is not required for Class D medical device MDACS registration in Hong Kong. However, the listing is valid for 5 years, and you must apply for renewal before the expiry date to maintain continuous registration.

No, annual renewal is not required for Class D medical device MDACS registration in Hong Kong. However, the listing is valid for 5 years, and you must apply for renewal before the expiry date to maintain continuous registration.

🔁 Renewal Policy for Class D MDACS Registration

ItemRequirement
Renewal FrequencyEvery 5 years
Annual Renewal❌ Not required
Who appliesThe Local Responsible Person (LRP)
Where to applyVia the MDIS portal
When to applyAt least 3–6 months before expiration
Documents requiredUpdated ISO 13485 certificate, latest regulatory approvals, updated device documents if changes occurred

📌 What Must Be Maintained During the 5-Year Validity?

Even without annual renewal, the following post-market responsibilities must be fulfilled continuously:

ResponsibilityDescription
✅ Adverse Event ReportingSubmit reports under GN-10
✅ Field Safety Corrective Actions (FSCA)Notify and manage product recalls (GN-11)
✅ Change NotificationsInform MDD of major changes in design, labeling, manufacturing, intended use, etc.
✅ QMS ValidityMaintain valid ISO 13485 certificate
✅ Surveillance ReadinessProvide updated documents if requested by MDD
✅ Contact ValidityKeep LRP and manufacturer details current in MDIS

🔁 What Happens During Renewal?

When the 5-year listing period is about to expire, the LRP must submit a renewal request, which may involve:

  1. Reviewing whether the technical documentation is still current

  2. Uploading any updated certificates (e.g., new CE certificate, ISO 13485 renewal)

  3. Verifying that the device model, label, intended use, and manufacturer are unchanged—or submitting change notifications if applicable

📎 If the device has changed significantly, MDD may request a partial or full re-review.

❗What If You Miss the Renewal Deadline?

  • The listing may expire, and your device may no longer be:

    • Listed on the MDACS website

    • Accepted in public hospital tenders

    • Permitted to be marketed or imported in Hong Kong

  • You may need to submit a new application, potentially with a full technical review again.

✅ Summary

QuestionAnswer
Is annual renewal required?❌ No
When is renewal required?✅ Every 5 years
How to renew?Through the MDIS portal, by the LRP
What happens if you don’t renew?Device listing lapses; re-registration may be needed

Would you like a renewal timeline checklist or a template for tracking ISO 13485 and MDACS expiration dates? I can prepare it based on your product portfolio.

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Contact Us：

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


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