For Class B medical device registration under Hong Kong MDACS, the technical documentation you need to prepare is essential to demonstrate that your device is safe, effective, and complies with applicable standards. Here are the typical technical documentation requirements:

Technical Documentation Requirements for Class B Medical Device Registration under MDACS

1. Device Description and Specifications

• Detailed description of the device, including:

  • Brand and model number(s)

  • Intended use and indications

  • Key specifications and features

  • Principle of operation

2. Classification Justification

• Explanation of why the device is classified as Class B according to MDACS rules.

3. Risk Management Documentation

• Summary of risk analysis following ISO 14971:

  • Identification of hazards

  • Risk evaluation and control measures

  • Residual risk assessment

4. Essential Performance and Safety Requirements

• Evidence showing compliance with applicable standards such as:

  • IEC 60601 series (for electrical devices)

  • ISO 10993 (biocompatibility)

  • Other relevant international or regional standards

5. Product Labeling and Instructions for Use (IFU)

• Copies of the proposed product labels, packaging, and user manuals.

• Must be in English or Traditional Chinese.

• Should meet MDACS labeling requirements (e.g., manufacturer info, warnings).

6. Quality Management System (QMS) Certificate

• ISO 13485 certification or equivalent quality system certification for the manufacturer.

7. Clinical or Performance Data (if applicable)

• Clinical evaluation reports or performance test results supporting device claims.

• This may be waived if the device is a low-risk product with substantial equivalence.

8. Verification and Validation Reports

• Testing reports related to product design, safety, electrical safety, EMC, software validation, etc.

9. Regulatory Approvals from Reference Markets

• Copies of certificates such as CE marking, FDA 510(k), TGA approval, or equivalent.

Additional Notes

• Documentation should be in English or Traditional Chinese.

• The files must be organized, clear, and complete to facilitate review.

• Hard copies are generally required for submission.

• All documents must be current and applicable to the exact device model(s) submitted.

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