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💰 Cost & ⏱️ Time Required for Class A Medical Device Registration under Hong Kong MDACS
✅ 1. Cost for Class A Medical Device Registration
As of 2025, the Medical Device Administrative Control System (MDACS) operated by the Hong Kong Department of Health is a voluntary system, and the registration of Class A medical devices is free of charge.
| Item | Cost (HKD) |
|---|---|
| LRP Listing Application | HK$0 |
| Class A Device Listing Application | HK$0 |
| Annual Maintenance Fees | None |
| Amendment/Update Fees | None (currently) |
⚠️ Note: The Hong Kong government has announced plans to transition to a mandatory regulatory framework in the future, which may involve fee schedules. For now, Class A device registration remains free under MDACS.
✅ 2. Time Required for Class A Registration
| Stage | Estimated Duration |
|---|---|
| Classification Confirmation | 1–3 days (internal check) |
| LRP Appointment & Listing | 1–2 weeks (if not listed yet) |
| Document Preparation | 1–2 weeks (depending on readiness) |
| MDD Review & Listing Decision | 1 to 3 months (typical) |
| Total Duration | 1 to 3 months (end-to-end, assuming no major delays) |
🔹 Timeline Factors:
Complexity and clarity of classification rationale
Completeness of submitted documents
Whether the LRP is already registered
MDD workload or follow-up queries
📌 Summary Table
| Item | Value |
|---|---|
| 💸 Registration Cost | HK$0 (free as of 2025) |
| ⏱️ Typical Timeline | 1–3 months |
| 📝 LRP Requirement | Yes, if manufacturer is overseas |
| 📄 Certificate Issued | No physical certificate; online listing only |
| 📌 Mandatory or Voluntary | Voluntary (subject to future regulation changes) |
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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