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Here is a detailed explanation of the procedures and steps for registering a Class B medical device under Hong Kong’s MDACS (Medical Device Administrative Control System):
✅ Overview: What Is the MDACS Process?
The MDACS is a voluntary listing system for medical devices in Hong Kong, managed by the Medical Device Division (MDD) of the Department of Health. For Class B medical devices (low–medium risk), the process includes demonstrating compliance with recognized regulatory standards (e.g., EU, FDA, TGA, etc.) and appointing a Local Responsible Person (LRP).
🧾 Step-by-Step Registration Procedures
🔹 Step 1: Determine Classification
Verify that your product qualifies as a Class B medical device according to MDACS classification rules (based on IMDRF/GHTF guidelines).
If unsure, consult the MDACS Classification Guide or request assistance from the Medical Device Division.
🔹 Step 2: Appoint a Local Responsible Person (LRP)
Only a Hong Kong-based company can act as an LRP.
The LRP submits the application and takes legal responsibility for post-market control.
The LRP must be authorized in writing by the overseas manufacturer (authorization letter required).
🔹 Step 3: Prepare Technical Documentation
You will need to compile a complete application dossier, which includes:
📄 A. Application Form
Use Form MD001: “Application Form for Listing of Medical Devices.”
Available from the MDD website.
📄 B. Supporting Documents
| Document | Description |
|---|---|
| Device Details | Trade name, model number, intended use, classification rationale |
| Conformity Assessment Certificate | CE certificate, FDA 510(k)/PMA, TGA, PMDA, Health Canada, or NMPA approval |
| Quality Management Certificate | ISO 13485 certificate of the manufacturer |
| Labeling and IFU | Labels, packaging, and user manuals in English or Chinese |
| Risk Management File | Summary per ISO 14971 |
| Clinical Evidence (if applicable) | Clinical evaluation report, study data, or literature review |
| Authorization Letter | From manufacturer to LRP (if applicable) |
🔹 Step 4: Submit the Application
Submit all documents neatly indexed and compiled.
No government fee is currently required.
🔹 Step 5: Application Review
The Medical Device Division conducts:
Initial screening for completeness.
Technical review of conformity documents and QMS.
Follow-up questions may be issued if clarification is needed.
🔹 Step 6: Device Listing
If approved, the device is added to the MDACS List of Medical Devices on the MDD website.
A listing certificate may be issued upon request.
The device is then eligible for:
Use in Hong Kong hospitals.
Public procurement opportunities.
🔹 Step 7: Post-listing Requirements
Notify the MDD of:
Any major changes to the device (design, labeling, etc.).
Adverse events or field safety corrective actions.
No annual renewal is required, but data must remain current.
⏱️ Timeframe
Standard timeline: 3–6 months, depending on:
Application quality.
Complexity of the device.
Whether additional information is requested.
💡 Helpful Tips
Ensure that your conformity certificate is valid and from a recognized regulatory authority.
Keep supporting documents clear, labeled, and well-organized to avoid delays.
Choose an experienced LRP familiar with MDACS procedures.
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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