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To register a Class B medical device under the Hong Kong MDACS (Medical Device Administrative Control System), you must prepare a detailed set of documents that demonstrate the safety, quality, and performance of the product. Below is a full list of required documents and guidance on how to prepare them.
📄 Required Documents for Class B Medical Device Registration (MDACS)
| No. | Document Name | Preparation Tips |
|---|---|---|
| 1 | Form MD001 – Application Form | Download from MDD website, fill in all fields clearly, and sign. |
| 2 | Device Description | Include brand, model(s), intended use, and general device design overview. |
| 3 | Classification Justification | Explain why the device is classified as Class B under MDACS rules. Use the MDACS classification system. |
| 4 | Proof of Conformity from Reference Market | CE Certificate, FDA 510(k), TGA approval, or other reference regulatory approvals. Ensure certificates are valid and issued by recognized authorities. |
| 5 | ISO 13485 Certificate | Quality system certificate from a recognized certification body. Ensure it covers the device scope. |
| 6 | Labeling and Packaging | Include samples of product labels, packaging, and Instructions for Use (IFU) in English or Chinese. Must comply with MDACS labeling requirements. |
| 7 | Risk Management Summary | Prepare a risk analysis based on ISO 14971. Include risk identification, mitigation measures, and residual risks. |
| 8 | Manufacturer’s Authorization Letter | If the manufacturer is overseas, provide a signed letter authorizing the Local Responsible Person (LRP) to handle registration. |
| 9 | Clinical/Performance Data (if applicable) | Required for certain device types. Summarize relevant clinical evaluation or performance testing. |
| 10 | Declaration of Conformity (optional but useful) | Indicates compliance with relevant standards (e.g., IEC 60601-1, ISO 10993). Helpful to support your application. |
🧾 How to Prepare the Documents
✅ General Tips:
Language: Documents must be in English or Traditional Chinese.
Format: Submit printed hard copies only — no electronic submissions accepted.
Document Structure: Organize documents in the order listed above; use dividers or index tabs for clarity.
Consistency: Make sure all device names, model numbers, and details are consistent across all documents.
Validity: Regulatory and quality certificates must be current (preferably issued within the past 3 years).
Legalization: The authorization letter may require notarization depending on the country of origin.
📌 Optional but Recommended:
Cover Letter – Briefly introduce the submission package and device overview.
Device Photos – Include clear photos of the product and packaging.
Design Verification Summary – Especially useful if you don’t have clinical data.
Post-Market Experience Summary – If the device is sold in other markets, include recall/adverse event history.
🧰 Need Help Preparing?
If needed, you can:
Hire a regulatory consultant in Hong Kong to review your documents.
Use the MDD Application Checklist (available on mdd.gov.hk) to verify completeness.
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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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