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The cost and time required for Class B medical device registration under MDACS (Medical Device Administrative Control System) in Hong Kong are relatively modest compared to mandatory regulatory systems in other countries. Below is a detailed overview:
💰 Cost of Class B MDACS Registration
| Item | Cost (Approx.) | Notes |
|---|---|---|
| Device Listing Application Fee | HK$500 per device | Payable upon submission of Form MD1 |
| LRP Registration (Form MD-TR) | Free | No fee required |
| Technical Support/Consultancy (if needed) | Varies (optional) | If using third-party consultants for submission support |
| Document Translation (if needed) | Varies | Chinese/English translation of IFUs and labels may be required |
| Postage/Notarization (if needed) | Minor | For hard copy submission and notarized authorizations |
📌 No government testing or review fee is charged, as MDACS is currently voluntary.
⏱️ Time Required for MDACS Registration (Class B Device)
| Stage | Estimated Time | Notes |
|---|---|---|
| Document Preparation | 2–4 weeks | Depends on readiness of CE/FDA/TGA certificates, ISO 13485, labels, IFU, etc. |
| LRP Appointment + MD-TR Submission | 1–2 weeks | If LRP is not yet registered |
| MDD Review of Form MD1 | 4–8 weeks (approx.) | May vary based on document quality and workload of MDD |
| Additional Clarifications (if any) | +2–4 weeks | If MDD requests more info or corrections |
📌 Total Estimated Time:
👉 6 to 12 weeks from complete submission to approval (for well-prepared applications).
📝 Tips to Speed Up the Process
Ensure all documents are complete, accurate, and clearly labeled.
Use recognized approvals (e.g., CE, FDA, TGA) to avoid submitting full technical documentation.
Provide translated IFU and labels (if not in English/Chinese).
Have a valid ISO 13485 certificate ready for the manufacturer.
Choose an experienced Local Responsible Person (LRP) who understands MDACS.
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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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