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To register a Class B medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong, you must follow a structured process administered by the Medical Device Division (MDD) of the Department of Health. Although MDACS is voluntary, registration is often required for public hospital procurement and improves local market acceptance.
🧭 1. Process for Class B Medical Device MDACS Registration
🔹 Step-by-Step Overview:
| Step | Description |
|---|---|
| 1. Appoint Local Responsible Person (LRP) | Must be based in Hong Kong and registered with the MDD. |
| 2. Classify the Device | Ensure it falls under Class B (low-to-medium risk) using MDACS classification rules. |
| 3. Prepare Documentation | Compile required certificates, forms, labeling, and technical information. |
| 4. Complete Application Form | Fill out Form MD1 for device listing. |
| 5. Submit to MDD | Hard-copy submission of Form MD1 + documents to the MDD office in Wan Chai. |
| 6. MDD Review | Application is assessed; queries may be raised. |
| 7. Listing Approval | If successful, the device is listed on the MDACS database. |
📄 2. Required Documents for Class B Device Registration
| Category | Required Document | Notes |
|---|---|---|
| Application Form | Form MD1 | Medical Device Listing Application Form |
| LRP Info | LRP appointment letter | From the manufacturer to the HK-based LRP |
| Quality Management | ISO 13485 certificate | Must be valid and cover manufacturing scope |
| Regulatory Approval | At least one from: CE Mark (MDD/MDR), FDA 510(k)/PMA, TGA ARTG, Health Canada, Japan PMDA | If unavailable, full technical file must be submitted |
| Manufacturer Info | Name, address, contact person | Business license may also be helpful |
| Device Info | Description, model list, classification justification | Including intended use |
| Declaration of Conformity (DoC) | Manufacturer-signed | Referencing regulatory approval and standards used |
| Labeling & IFU | Product label, outer packaging, instructions for use | Must be in English or Chinese (or both) |
| Risk Classification | Justification that device is Class B | Based on MDACS/GHTF rules |
✅ All documents should be in English or Chinese, or accompanied by certified translations.
🕒 3. Timeline
| Phase | Duration (Approx.) |
|---|---|
| Document preparation | 2–4 weeks (depends on readiness) |
| MDD review process | 4–8 weeks (can vary based on submission quality and complexity) |
📌 Total estimated time: 6–12 weeks
💰 4. Cost
| Item | Fee |
|---|---|
| MDACS Listing Fee (Form MD1) | HK$500 per device |
| LRP Registration (Form MD-TR) | Free |
| Other Costs | Optional consultancy, translation, notarization |
⚠️ 5. Important Considerations
✅ Local Responsible Person (LRP)
Must be appointed by the manufacturer.
Handles all communication with the MDD.
Responsible for post-market surveillance, incident reporting, and recalls.
✅ Valid Regulatory Approval
Prior recognition from a reference market (EU/US/AUS/CA/JP) simplifies approval.
If unavailable, full technical documentation must be submitted.
✅ Language Requirements
All documents, especially labels and IFU, must be in English or Chinese.
✅ Labeling Standards
Ensure labels meet MDACS expectations for safety symbols, warnings, model numbers, etc.
✅ Post-Market Obligations
Once listed, the LRP must monitor device safety and report adverse events.
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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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