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No, Class C medical device registration under the MDACS system in Hong Kong does not require annual renewal.
However, while the listing itself does not expire, the Local Responsible Person (LRP) and manufacturer are responsible for ongoing compliance and periodic updates to maintain the device’s validity on the MDACS database.
✅ Summary: Renewal & Maintenance Requirements
| Aspect | Requirement | Renewal Needed? |
|---|---|---|
| Device Listing (Form MD102) | Listing is indefinite unless changes occur | ❌ No annual renewal |
| Manufacturer Registration (Form MD101) | No expiration if no changes | ❌ No annual renewal |
| LRP Registration (Form MD100) | No expiration, but changes must be notified | ❌ No annual renewal |
| Post-market Monitoring | Ongoing duty (e.g., incident reporting) | ✅ Continuous |
| Technical Documentation Updates | Required if IFU, labeling, CE/FDA certificates change | ✅ As needed |
| Certificates (e.g., CE, ISO 13485) | Must remain valid | ✅ Update when expired |
🔄 When You Must Notify or Update the MDD
Although annual renewal isn’t required, you must notify the Medical Device Division (MDD) if there are any material changes, including:
| Type of Change | Action Required |
|---|---|
| 🔄 Change in LRP | Notify with new MD100 form and authorization |
| 🏭 Change in manufacturer or manufacturing site | Update Form MD101 |
| 📑 Updates in CE/FDA certificates | Submit latest version to MDD |
| 🖨 Labeling/IFU changes | Submit revised versions |
| ⚠️ Field Safety Corrective Actions (FSCA) or recalls | Report immediately using MD151 |
| 🧪 Change in intended use or design | May require new submission/review |
🛑 What Happens If You Don’t Update?
Failure to notify MDD of changes can result in:
Delisting of the product
Removal from public procurement eligibility
Legal complications if adverse events occur
Loss of buyer/distributor trust
📌 Post-Market Surveillance (Ongoing Duties)
Even without annual renewal, you must:
| Obligation | Frequency |
|---|---|
| Adverse event reporting (Form MD151) | As soon as possible |
| Device performance monitoring | Continuous |
| Safety alert communication | Prompt and documented |
| Document retention | At least 5 years post-distribution |
🧾 Important: Certificate Expiration ≠ MDACS Expiration
MDACS listing remains valid only as long as the supporting documentation (e.g., ISO 13485, CE/FDA approval) remains valid. If a key certificate expires or is withdrawn, your listing becomes non-compliant, even though no formal renewal process exists.
✅ Final Answer
No, Class C MDACS registration does not require annual renewal in Hong Kong.
However, you must maintain post-market obligations and update the Medical Device Division if there are changes to the LRP, manufacturer, certificates, or product information.
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Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn
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Whatsapp or Wechat：+86 15816864648
Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
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