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The time required to obtain Class D medical device MDACS registration in Hong Kong typically ranges from 4 to 9 months, depending on the complexity of the device, the completeness of the application, and the responsiveness of the applicant and Local Responsible Person (LRP).
Class D devices are high-risk medical devices (e.g., implantables, life-sustaining devices, high-risk IVDs), so the Medical Device Division (MDD) of the Department of Health (DoH) applies stringent technical review procedures.
⏱️ Estimated Timeline Breakdown for Class D MDACS Registration
| Stage | Activities | Estimated Duration |
|---|---|---|
| 1. Preparation Phase | - Appoint LRP - Prepare technical dossier and supporting documents | 1–3 months (manufacturer-dependent) |
| 2. Submission via MDIS | - Submit application and upload documents through the Medical Device Information System (MDIS) | ~1 week |
| 3. Administrative Screening | - MDD checks completeness, format, documentation (not a technical review yet) | 2–4 weeks |
| 4. Technical Evaluation | - In-depth review of safety, effectiveness, CE/FDA certificates, ISO 13485, risk files, clinical data | 3–6 months |
| 5. Request for Clarification (RFC) | - MDD may ask questions or request more documents - LRP/applicant must respond | 2–8 weeks per round |
| 6. Final Listing Decision | - Listing number issued if approved - Device listed on MDACS portal | 1–2 weeks |
🧮 Typical Total Time: 4–9 months
🕰 In more complex cases (e.g. software-based, novel technology), the timeline may extend to 12 months.
📍 Real-World Timing Factors
| Factor | Impact |
|---|---|
| ✅ High-quality, complete dossier | Speeds up technical review |
| ❌ Missing documents or labeling issues | Causes clarification delays |
| ✅ Valid CE, FDA, TGA approvals | May reduce the scope of review |
| ❌ No clinical data or poor risk file | Triggers longer technical review |
| ✅ Prompt RFC responses by LRP | Keeps the timeline on track |
📝 Example Timeline (Typical Class D Implant Device)
| Activity | Month |
|---|---|
| Device dossier prepared | Jan–Feb |
| Submission to MDIS | March |
| Admin check completed | Late March |
| Technical review begins | April |
| Clarification requested and responded | May–June |
| Final approval and listing | July–August |
⏱ Total time: ~6–7 months
📌 Tips to Accelerate Registration
✅ Submit a well-structured technical dossier (aligned with GN-01 or GN-02)
✅ Ensure valid ISO 13485 and CE/FDA certificates are included
✅ Provide bilingual labeling and IFU (English + Traditional Chinese)
✅ Appoint an experienced Local Responsible Person (LRP)
✅ Respond to MDD queries within 10–20 days
✅ Summary
| Question | Answer |
|---|---|
| How long does it take to obtain MDACS Class D registration? | 4–9 months (average) |
| What’s the shortest realistic timeframe? | 4–5 months (very complete file, fast responses) |
| What’s the longest timeframe? | 9–12+ months (complex or incomplete applications) |
Would you like a customized Gantt chart or project management template to track your MDACS Class D registration milestones? I can create one based on your device type and status.
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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