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For Class B medical device registration under MDACS in Hong Kong, here’s a typical time frame and the review steps involved:
Time Frame for Class B MDACS Registration
| Stage | Typical Duration |
|---|---|
| Preparation of Application | Depends on your readiness (usually 2-4 weeks) |
| Submission to Medical Device Division (MDD) | Day 0 (application date) |
| Initial Screening | ~2-4 weeks |
| Technical Review | ~4-8 weeks |
| Approval and Listing Number Issuance | ~1-2 weeks after review completion |
| Total Estimated Time | Typically 8-14 weeks (2 to 3.5 months) |
Review Steps for Class B MDACS Registration
1. Initial Screening
MDD checks for completeness of the application.
Verifies all required documents and fees are submitted.
If incomplete, MDD requests supplementary information.
2. Technical Review
Detailed examination of:
Technical documentation (device specs, labeling, IFU)
Risk management files
Quality Management System certification (ISO 13485)
Valid reference market approvals (e.g., CE mark, FDA clearance)
Assessment of conformity with MDACS Essential Principles.
3. Communication
MDD may issue queries or request clarifications.
Applicant must respond promptly to avoid delays.
4. Decision
Upon satisfactory review, MDD approves the registration.
Issue a device listing number to the applicant.
Additional Notes:
Delays often occur due to incomplete submissions or slow responses to MDD queries.
Proactive preparation and timely replies can help ensure smoother and faster processing.
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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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