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What documents are required for Class II medical device MDACS registration in Hong Kong? How to prepare the application files?
Release time：2025-04-28 16:12:26 The author: source:
When applying for Class II medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, the following documents must be prepared carefully to show compliance with safety, performance, and quality standards.

When applying for Class II medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, the following documents must be prepared carefully to show compliance with safety, performance, and quality standards.

1. Required Documents

CategoryRequired DocumentNotes
A. Application FormsCompleted Application Form (Form MD-1 or MD-2)- For new listing (MD-1) or amendments (MD-2).
- Downloadable from the Department of Health (DH) website.
B. Manufacturer InformationManufacturer’s Details- Name, address, and contact person.
- Business Registration Certificate of the manufacturer (optional but recommended).

Good Manufacturing Practice (GMP) Certificate- Proof that the manufacturer operates under an ISO 13485 or equivalent QMS.
- Issued by an accredited certification body.

Certificate of Free Sale (CFS)- Shows the device is legally sold in the manufacturing country.
- Issued by the competent authority.
C. Device InformationProduct Description- Including intended use, indication, working principle, and features.

Device Model List- A list of models and variants covered by the registration.

Brochure/User Manual- English or Chinese.
- Clear instructions for use, safety information, maintenance.

Device Label Samples- Labeling must include:
• Product name
• Manufacturer
• Intended use
• Instructions and warnings
- Both primary and secondary packaging labels if applicable.
D. Safety and Performance ProofEvidence of ConformityAcceptable evidence includes:
• CE Certificate
• FDA 510(k) clearance
• Japan PMDA approval
• Australian TGA inclusion

Declaration of Conformity (DoC)- Manufacturer's declaration that the product conforms to relevant standards.

Risk Analysis Report- In accordance with ISO 14971 risk management standard.

Test Reports- Reports demonstrating the device meets applicable standards (e.g., electrical safety IEC 60601, biocompatibility ISO 10993).
E. Clinical Evidence (if applicable)Clinical Evaluation Report (CER)- Particularly for higher-risk Class II devices.
- Can be based on literature, clinical trials, or device equivalence.
F. OthersAuthorized Representative Agreement (if applicable)- Required if the manufacturer is overseas.
- A letter of appointment for the local representative.

2. How to Prepare the Application Files

Step 1: Gather Documents

  • Collect all documents listed above from the manufacturer, test labs, notified bodies, and your internal technical team.

Step 2: Format and Organize

  • Language: Documents should be in English or Chinese.

  • Labeling: Ensure all files are clearly named (e.g., “Risk_Analysis_Report_ModelX.pdf”).

  • Combine smaller documents into one PDF for each category (for example, all labels into one "Labeling.pdf").

Step 3: Complete the Forms

  • Download and carefully complete the MD-1 Application Form (for initial listing).

  • Fill in all sections truthfully and clearly, including:

    • Manufacturer details

    • Device details (model, type, intended use)

    • Safety certification references

Step 4: Quality Check

  • Review all documents for:

    • Completeness

    • Consistency (e.g., the device name and model numbers must match across all documents)

    • Signature and stamp requirements (where needed)

Step 5: Submission

  • Online (Preferred if available): Upload your documents through MDACS e-submission platform (if you are registered).

  • Physical (if required): Prepare a printed set and send it by courier or hand deliver to the Medical Device Control Office.

⚠️ Important Notes (Precautions):

  • Consistency is critical: Minor inconsistencies (even model numbers, addresses, etc.) between documents can lead to application rejection.

  • Authorized Representative: If you’re not the manufacturer, ensure your local representative’s appointment letter is signed, dated, and valid.

  • Use valid and current certificates: Make sure all regulatory certificates (e.g., CE, FDA) are active (not expired).

  • Clinical Evidence: For certain Class II devices (e.g., implantable, active devices), more robust clinical data may be required.

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