.png)
.jpg)
The processing time for Class D medical device MDACS registration in Hong Kong varies depending on the completeness of the application, the complexity of the device, and whether the Medical Device Division (MDD) requires additional information. Since Class D devices are high-risk, they undergo more rigorous review, which can lengthen the timeline.
Below is a detailed breakdown of the estimated timeline:
⏳ Estimated Processing Time for Class D MDACS Registration
| Stage | Estimated Duration |
|---|---|
| ✅ Document preparation | 1–3 months (depending on readiness) |
| ✅ MDIS submission review (admin check) | 2–4 weeks (initial completeness check) |
| ✅ Technical review by MDD | 3–6 months (may extend to 9–12 months for complex devices) |
| ✅ Clarification & response period | 2–4 weeks per round of questions |
| ✅ Final approval and listing | 1–2 weeks after acceptance |
🧮 Total Average Timeline:
~4 to 9 months from submission to final listing
May extend up to 12 months if:
The device is novel or complex
Clinical data is insufficient or unclear
The MDD issues multiple rounds of questions
📌 Factors That Can Affect Timeline
✅ 1. Quality of Submission
A well-prepared, complete dossier accelerates the review.
Missing documents or poorly formatted files delay progress.
✅ 2. Device Complexity
High-tech devices (e.g. implantables, drug-device combinations, AI-enabled devices) require deeper evaluation.
✅ 3. MDD Workload
MDACS is still a voluntary system, but MDD reviews can be delayed during peak periods or transition phases (e.g., updates to legislation or MDIS).
✅ 4. Responsiveness to Queries
Each MDD query extends the process.
Prompt and complete replies via MDIS reduce delays.
⏱️ Tips to Shorten the Timeline
| Tip | Benefit |
|---|---|
| Prepare documents using the official checklist | Avoids rejection due to missing items |
| Appoint an experienced Local Responsible Person (LRP) | Ensures smoother submission and handling of queries |
| Provide clear and up-to-date clinical evidence | Speeds up technical assessment |
| Monitor MDIS dashboard actively | Respond quickly to MDD clarifications |
| Use GHTF-recognized approvals (e.g., CE under MDR, FDA PMA) | Builds reviewer confidence in the product |
📋 Summary Timeline Table
| Step | Estimated Duration |
|---|---|
| Pre-submission preparation | 1–3 months |
| Submission via MDIS | 1 day (online system) |
| Administrative screening | 2–4 weeks |
| Technical assessment | 3–6 months (or more) |
| Response to queries | 2–4 weeks per round |
| Final listing approval | 1–2 weeks |
| Total Estimated Duration | 4–9 months (can extend to 12) |
Would you like a Gantt chart-style timeline or a milestone tracker template to help plan your submission and follow up? I can create that based on your product type and submission readiness.
.png)
.png)