For Class A medical device registration under Hong Kong’s MDACS (Medical Device Administrative Control System), the technical documentation requirements are relatively straightforward because Class A devices are considered low-risk. However, it is important to ensure that the documentation submitted is complete and compliant with Hong Kong’s regulatory standards. Below are the key technical documentation requirements:

✅ 1. MD-TRF Form (Application Form)

• Purpose: This form is required to officially submit the device for registration.

• Contents:

  • Device name, model, and classification

  • Manufacturer’s name and address

  • Local Responsible Person (LRP) details (if applicable)

  • Device description and intended use

  • Classification justification (to explain why the device is classified as Class A)

✅ 2. Device Description

• Purpose: To provide a comprehensive understanding of the device’s characteristics.

• Contents:

  • Technical Specifications: Detailed information about the device, including materials used, dimensions, features, and performance characteristics.

  • Functional Description: How the device works and its intended purpose (e.g., what it does, how it is used).

  • Illustrations/Diagrams: If applicable, provide diagrams or images of the device, including any parts or accessories.

  • Standards Compliance: Although not required for Class A, it is advisable to mention if the device complies with any international standards (e.g., ISO 13485, CE marking, etc.).

✅ 3. Classification Justification

• Purpose: To explain why the device qualifies as a Class A medical device under the MDACS rules.

• Contents:

  • Explanation of how the device meets the Class A criteria:

    • Non-invasive (no entry into the body)

    • Low-risk (minimal risk to patients or users)

    • Non-sterile (does not require sterilization)

    • Non-measuring (no active measurement of biological parameters)

    • Non-implantable (not intended to remain in the body)

  • Refer to the MDACS Classification Guidance (GN-01) for specific rules.

✅ 4. Labeling and Instructions for Use (IFU)

• Purpose: To ensure the device is appropriately labeled for safety, regulatory compliance, and user guidance.

• Contents:

  • Labeling:

    • Product name and model number

    • Manufacturer name and address

    • Intended use

    • Warnings, symbols, or precautions (if applicable)

    • Local Responsible Person (LRP) details (if applicable)

    • Batch/lot number and expiration date (if applicable)

  • Instructions for Use (IFU):

    • Clear, concise instructions for proper use

    • Information on potential risks or side effects (if applicable)

    • Information on maintenance, storage, and disposal

    • Must be in English or Traditional Chinese.

✅ 5. Manufacturer Information

• Purpose: To provide official identification and background of the device’s manufacturer.

• Contents:

  • Manufacturer’s Business Registration: Proof of the manufacturer’s identity and legal status.

  • ISO 13485 Certificate (optional but recommended): While not required for Class A devices, it demonstrates compliance with quality management systems and can support your application.

  • CE Declaration of Conformity (optional but beneficial): If the device is already certified in other markets (e.g., EU), submit the CE marking or relevant regulatory approval documents.

✅ 6. Regulatory Approval Evidence (Optional)

While not mandatory for Class A devices, submitting evidence of regulatory approval in other markets (such as CE, FDA, or TGA) can enhance the credibility and approval process.

• Examples:

  • CE Marking: Declaration of Conformity if the device is already CE marked.

  • FDA 510(k) or 510(k) Exemption for devices already cleared in the USA.

  • TGA Approval for devices approved in Australia.

✅ 7. Post-Market Surveillance and Vigilance Procedures (Optional but Recommended)

• Purpose: Even though post-market surveillance is not strictly required for Class A devices, it is good practice to include a plan for monitoring the device after it is placed on the market.

• Contents:

  • Procedures for reporting adverse events (if applicable).

  • A system for tracking product recalls or safety-related incidents.

📝 Summary of Key Technical Documentation for Class A Medical Device Registration

1. MD-TRF Form – Application form.

2. Device Description – Technical and functional details of the device.

3. Classification Justification – Rationale for Class A classification.

4. Labeling and IFU – Labeling, packaging, and user instructions.

5. Manufacturer Information – Company registration and, optionally, ISO certificates.

6. Regulatory Approval Evidence – CE, FDA, or similar approvals (optional for Class A).

7. Post-Market Surveillance – Optional but recommended for device monitoring after market entry.

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