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The processing time for Class B medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong typically depends on the completeness and quality of the submission. Below is a breakdown of the expected timeline:
⏳ Processing Time for Class B MDACS Registration
| Stage | Description | Estimated Time |
|---|---|---|
| 1. Document Review by MDD | Initial check for completeness and eligibility of documents | ~2–4 weeks |
| 2. In-depth Technical Assessment | Evaluation of regulatory approvals, ISO 13485, labeling, risk classification, etc. | ~4–6 weeks |
| 3. Clarification Requests (if any) | MDD may request additional documents or clarifications | Adds 2–4 weeks (depending on response time) |
| 4. Final Decision and Listing | Once all requirements are met, MDD issues a letter confirming listing | ~1 week |
✅ Total Average Processing Time
6 to 10 weeks, provided the application is complete and clear on first submission.
⏱️ What Can Affect the Timeline?
| Factor | Impact |
|---|---|
| ❌ Incomplete or inconsistent documentation | Major delays – leads to MDD queries |
| 📄 Lack of prior regulatory approval | Requires full technical documentation → longer review |
| 🇭🇰 Unregistered or delayed LRP registration | Cannot proceed with application |
| 📝 Errors in Form MD1 or missing signatures | Application will be rejected or delayed |
| 📬 Delays in courier delivery or cheque issues | Slows down physical application handling |
📌 Tips to Ensure Timely Processing
Double-check that all documents are consistent and translated if needed.
Ensure ISO 13485 and reference market certificates are valid.
Submit a well-organized, tabbed hard copy binder with a checklist.
Appoint and register the Local Responsible Person (LRP) early.
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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