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The processing time for registering a Class C medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong generally takes about 4 to 6 months, depending on the quality of the submission and the response time to any requests for additional information.
⏳ Estimated Processing Timeline for Class C MDACS Registration
| Stage | Description | Timeframe |
|---|---|---|
| ✅ Document Preparation | Forms, technical dossier, translations, manufacturer & LRP registration | 4–8 weeks |
| 📥 Application Submission | Submit printed documents + soft copy (USB/CD) to MDD | 1–3 days (courier/in-person) |
| 🔍 Initial Screening | MDD checks for completeness of forms and attachments | 1–2 weeks |
| 🧪 Technical Evaluation | In-depth review of technical documents, approvals, safety & performance data | 8–12 weeks |
| ❓ Queries/Clarifications (if needed) | MDD may request missing documents or additional explanations | 2–4 weeks (response-dependent) |
| ✅ Final Decision | Listing approved and device assigned a MDACS listing number | 2–3 weeks |
📌 Total Average Time: 4 to 6 months
⏱ Best-case (complete, well-prepared submission): ~4 months
⏱ Typical-case (minor queries or translation delays): ~5–6 months
⏱ Worst-case (major deficiencies): 6–9+ months or rejection
⚠️ Factors That Can Delay Processing
| Factor | Impact |
|---|---|
| ❌ Incomplete forms (MD100, MD101, MD102) | Application may be returned |
| ❌ Missing CE/FDA approvals or ISO 13485 certificate | Listing put on hold |
| ❌ Improper labeling (not in English or Chinese) | Additional revision required |
| ❌ Poorly organized dossier or missing sections | Prolonged review |
| ❌ Slow response to MDD clarifications | Extends review timeline |
📎 Tips to Speed Up Processing
✅ Ensure your device is already approved in at least one reference market
✅ Submit all forms correctly (MD100, MD101, MD102)
✅ Label and organize your technical dossier clearly
✅ Use English or Chinese for all IFU and labels
✅ Work with an experienced Local Responsible Person (LRP) to ensure complete submission
✅ Respond promptly to any MDD requests
🧾 Summary Table: Class C MDACS Timeline
| Activity | Time Estimate |
|---|---|
| Preparation | 1–2 months |
| Review by MDD | 3–4 months |
| Total Time | 4–6 months |
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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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