The technical documentation for Class IV medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) is critical to demonstrate the safety, efficacy, and compliance of the device with applicable regulatory standards. Class IV devices are considered high-risk, and as such, the technical documentation must be comprehensive and thorough.

Here is a detailed list of the technical documentation requirements for Class IV medical device registration under Hong Kong MDACS:

1. Device Description

• A detailed description of the medical device, including:

  • Device name and model number.

  • Intended use and indications.

  • Design features and materials used.

  • Functionality and how it is intended to perform its medical purpose.

  • Manufacturing process and specifications (including sterilization, if applicable).

  • Packaging details and labeling information.

2. Risk Management Documentation

• A Risk Management File in accordance with ISO 14971 (Risk Management for Medical Devices), including:

  • Risk analysis of the device throughout its lifecycle.

  • Risk control measures implemented to mitigate identified risks.

  • Residual risk assessment after mitigation.

  • Monitoring of risks and post-market surveillance (PMS) strategy.

3. Clinical Evaluation Report (CER)

• A Clinical Evaluation Report (CER) demonstrating that the device meets the clinical requirements for safety and performance.

  • Clinical evidence from clinical studies, literature reviews, or equivalence to already approved devices.

  • Post-market clinical data (if applicable).

  • Literature and scientific evidence supporting the device’s intended use and performance.

4. Quality Management System (QMS) Documentation

• Proof that the manufacturer has a Quality Management System (QMS) in place, compliant with ISO 13485 (Medical Devices - Quality Management Systems).

  • ISO 13485 Certificate or equivalent.

  • Internal audits, risk management procedures, design controls, and document control practices that ensure consistent device quality.

5. Manufacturing Information

• Manufacturer information, including:

  • Full name and address of the manufacturer.

  • A declaration that the manufacturer’s facilities comply with Good Manufacturing Practices (GMP) or ISO 13485 standards.

  • Any third-party certification related to manufacturing practices.

6. Labeling and Instructions for Use (IFU)

• Labeling information for the device, which must meet regulatory requirements for Hong Kong:

  • Device name, model number, manufacturer name and address.

  • Instructions for Use (IFU), which include:

    • Intended purpose.

    • Indications, contraindications, and warnings.

    • Detailed step-by-step instructions on how to use the device safely.

    • Precautions, possible adverse effects, and the expected clinical outcome.

  • The labeling must also be legible and in English and/or Chinese.

7. Performance Testing Data

• Preclinical performance data such as:

  • Bench testing, biocompatibility, electrical safety testing (if applicable).

  • For devices that require sterilization, sterilization validation data.

  • Packaging validation to ensure the device is transported and stored under appropriate conditions.

8. Post-Market Surveillance (PMS) and Vigilance Plan

• A detailed Post-Market Surveillance (PMS) plan to monitor the safety and performance of the device once it is on the market.

  • Adverse event reporting systems.

  • A process for conducting field safety corrective actions (FSCA) or recalls if necessary.

  • Periodic reviews and updates of clinical data and risk management measures.

9. International Approvals

• Proof of prior approval in a reference country (e.g., FDA, CE mark, TGA, PMDA):

  • Copy of the certificate of conformity or approval letter from the regulatory authority in the reference country.

  • Evidence that the device complies with international standards (e.g., CE certification, FDA clearance, etc.).

  • For devices approved in the EU, a CE mark and Notified Body certificate would be required.

10. Instructions for Device Maintenance and Calibration

• Instructions on how the device should be maintained and calibrated to ensure it continues to perform as intended throughout its lifecycle.

Additional Documents and Requirements

1. Declaration of Conformity:

   • A Declaration of Conformity stating that the device meets all the essential requirements outlined by MDACS and relevant international standards.

2. Declaration of the LRP:

   • A signed declaration from the Local Responsible Person (LRP) confirming their role and responsibilities in the regulatory process.

3. Any Specific Device-Specific Requirements:

   • Some high-risk devices may require additional documentation, such as specialized testing for software (if the device has software), animal testing data, or special clinical evaluations.

Key Considerations When Preparing Technical Documentation

• Accuracy and completeness: All documents submitted must be thorough, accurate, and current.

• Compliance with standards: Ensure that the device and its documentation comply with the standards and regulations set forth by ISO, MDACS, and relevant reference countries.

• English and Chinese: Labeling and documentation must be provided in English and Chinese, as required by Hong Kong regulations.

• Timeliness: Ensure that you submit all the required documents in a timely manner to avoid delays in the approval process.

Would you like more information or assistance with preparing any specific part of the technical documentation?

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