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The cost and time required to apply for Class B medical device registration under Hong Kong’s MDACS (Medical Device Administrative Control System) are outlined below:
💰 Cost of MDACS Registration for Class B Devices
✅ Government Fees
Currently, there is NO official application fee charged by the Hong Kong Department of Health for listing Class B medical devices under MDACS.
(This makes it more cost-effective compared to many other jurisdictions.)
💼 Other Potential Costs
| Item | Estimated Cost (HKD/USD) | Notes |
|---|---|---|
| Local Responsible Person (LRP) | HKD 10,000–30,000/year (USD ~1,300–3,800) | Varies depending on service scope and provider |
| Document Preparation/Consulting | HKD 5,000–30,000+ (USD ~650–3,800+) | If using consultants for technical file, risk report, etc. |
| Translations | HKD 1,000–5,000+ per language | If labels or IFU need translation into English or Chinese |
| Notarization/Legalization | HKD 500–2,000+ | For authorization letters, depending on country requirements |
💡 Tip: If you already have CE/FDA/TGA approval and ISO 13485, costs are minimal since many documents are reusable.
⏱️ Time Required for MDACS Registration
| Stage | Estimated Time |
|---|---|
| Document Preparation | 2–4 weeks (if documents are ready) |
| Internal Review by LRP | 1–2 weeks |
| Submission to MDD (Dept. of Health) | Immediate upon document readiness |
| Review by MDD (Processing Time) | Typically 3 to 6 months, depending on: |
| • Quality/completeness of submission | |
| • Need for clarification or supplemental info | |
| Total Timeline (Typical) | ~3–6 months from submission to approval |
🕒 Faster review is possible if:
You submit all documents correctly the first time.
Your conformity certificates (e.g., CE, FDA 510(k), ISO 13485) are valid and recent.
✅ Summary
| Aspect | Details |
|---|---|
| Government Fee | None (as of now) |
| Other Costs | HKD 15,000–60,000+ depending on LRP, documents |
| Timeframe | Average 3–6 months from submission to listing |
Would you like a cost breakdown template or a referral for trusted LRP or technical consultants in Hong Kong?
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