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Here is a comprehensive guide to the process, required documents, and key precautions for Class B medical device registration under the Hong Kong MDACS (Medical Device Administrative Control System):
🧭 I. Registration Process for Class B Medical Devices
Step 1: Determine Classification
Classify the medical device according to MDACS rules.
Class B includes low-to-medium risk devices (e.g., surgical gloves, thermometers, wound dressings).
Step 2: Appoint a Local Responsible Person (LRP)
Must be a registered legal entity in Hong Kong.
Must be authorized by the manufacturer (with formal documentation).
The LRP submits and maintains the registration.
Step 3: Prepare Technical and Regulatory Documents
Assemble all required forms, certificates, and supporting documents (see Section II).
Step 4: Submit the Application
Complete Form MD001.
Submit hard copy of the application package to the Medical Device Division (MDD):
Address: 21/F, Wu Chung House, 213 Queen’s Road East, Wan Chai, Hong Kong
Step 5: Application Review by MDD
The Department of Health will review the submission.
They may request clarifications or additional information.
Step 6: Device Listing
Once approved, the Class B device is listed on the “List of Medical Devices” maintained by the MDD.
The listing is not equivalent to a product license, but serves as voluntary recognition of safety and quality.
📄 II. Required Documents for Class B Device Listing
| Document | Description |
|---|---|
| Form MD001 | Application form for device listing |
| Device Description | Model number(s), intended use, classification rationale |
| Risk Classification Justification | According to MDACS rules |
| Regulatory Approvals | Proof of approval in reference markets (e.g., CE, FDA, TGA, NMPA, etc.) |
| Quality Management System (QMS) | ISO 13485 certificate from recognized certification body |
| Labels and Instructions for Use (IFU) | Must be in English or Chinese, include all packaging and labeling |
| Authorization Letter | Manufacturer’s letter authorizing the LRP (if manufacturer is overseas) |
| Clinical Data or Performance Evidence | If applicable (especially for novel or diagnostic devices) |
| Risk Management Summary | As per ISO 14971 |
| Declaration of Conformity / Safety Reports | Optional but may strengthen application |
⚠️ III. Precautions and Key Points
| Area | Important Notes |
|---|---|
| Accuracy of Documents | All submitted documents must be accurate, consistent, and up to date |
| Document Format | Must be hard copy (no electronic submission), English or Chinese only |
| LRP Responsibilities | Ensure your LRP is reliable, as they are responsible for post-market actions |
| Scope of Authorization | The LRP must have a signed authorization letter covering the exact device |
| Post-Market Obligations | Incident reporting, product recalls, and updates to MDD are required |
| Changes Post-Listing | Any change in model, design, label, or manufacturing site must be reported |
| Listing ≠ Regulatory Approval | MDACS is voluntary and does not replace import or sale licenses |
📌 Summary
| Item | Detail |
|---|---|
| Application Type | Voluntary listing under MDACS |
| Responsible Party | Local Responsible Person (LRP) |
| Submission Format | Hard copy to the Medical Device Division (MDD) |
| Estimated Timeframe | 3–6 months after submission |
| Application Fee | None (as of now) |
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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