For Class I IVD medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), the following technical document requirements apply. These documents are necessary to demonstrate that the device meets the safety, performance, and regulatory standards required by the Medical Device Division (MDD) of the Department of Health.

1. Device Description

• A detailed description of the medical device, including:
  • Name of the device and model number.
  • Intended use of the device (e.g., diagnostic purpose, target condition).
  • Device function and key specifications.
  • Principle of operation (how the device works to achieve its intended purpose).
  • Device components, including materials and any sub-components.

2. Labeling and Instructions for Use (IFU)

• Device Labeling: Provide a copy of the label(s) that will be affixed to the device, packaging, or container, including the following information:
  • Manufacturer's name and address.
  • Device name and model.
  • Intended use or indications for use.
  • Safety warnings, contraindications, or limitations.
  • Storage and handling instructions.
• Instructions for Use (IFU): Detailed instructions to guide users on how to operate the device safely, including:
  • Step-by-step usage instructions.
  • Warnings and precautions to ensure safe use.
  • Troubleshooting tips, if necessary.
  • Disposal instructions, if applicable.

3. Risk Management and Safety Assessment

• Risk Analysis: Conduct and document a risk assessment for the device, identifying any potential hazards during its use. This should include:
  • Hazards: Physical, chemical, or biological risks related to the device (e.g., contamination, failure, improper use).
  • Risk control measures: How the identified risks will be mitigated (e.g., device design changes, labeling warnings).
  • Residual risk: Any remaining risks that cannot be fully mitigated and how they will be managed.
• Compliance with ISO 14971: The risk management process should be in compliance with ISO 14971 (Risk management for medical devices), which is the internationally recognized standard for medical device risk management.

4. Evidence of Safety and Performance

• Clinical and Performance Data (if applicable):
  • For Class I IVDs, clinical data may not always be required, but performance data should be included to demonstrate the device’s effectiveness and reliability. For example:
    • Laboratory testing results (e.g., sensitivity, specificity, accuracy).
    • Validation studies confirming the device’s performance in a controlled environment.
  • Include literature reviews or data from recognized standards or previous studies if the device is similar to others already in the market.
• Regulatory Approvals: If the device has been approved by other regulatory bodies (e.g., CE mark, FDA), include copies of the approval certificates and any related documentation to support the safety and performance of the device.

5. Declaration of Conformity

• A Declaration of Conformity signed by the manufacturer, confirming that the device complies with all applicable Hong Kong medical device regulations and international standards.
• This document should state that the device meets the safety and performance standards and confirm compliance with any relevant regulations like ISO 13485 (Quality Management Systems for medical devices) or other recognized standards.

6. Quality Management System (QMS) Documentation (Optional but Recommended)

• While ISO 13485 certification is not mandatory for Class I devices, it is highly recommended to have QMS documentation that demonstrates how the manufacturer ensures quality throughout the lifecycle of the device.
• If ISO 13485 certification is not available, include a description of the manufacturer’s quality control procedures:
  • Design controls: Procedures for ensuring the design meets the specified requirements.
  • Production controls: Measures to ensure that manufacturing processes maintain quality.
  • Post-market surveillance: Procedures to monitor and report any adverse events after the device is on the market.

7. Performance Testing (If Required)

• Depending on the type of Class I IVD device, additional performance testing may be required to prove its accuracy, reliability, and efficacy in specific applications.
• Stability and shelf-life testing may be necessary if the device has a time-dependent performance factor, such as reagents or testing kits that degrade over time.

8. Manufacturer Information

• Full contact information of the manufacturer, including:
  • Manufacturer’s name, address, and contact details.
  • For non-local manufacturers, information about the authorized representative in Hong Kong (if applicable).
• Include documentation that verifies the manufacturer’s business registration and authority to market the product.

General Document Guidelines:

• Document Language: All documents must be submitted in English or Chinese.
• Document Format: Ensure that all documents are complete, accurate, and legible.
• Document Consistency: Information across all documents (e.g., device name, model) must be consistent.

Conclusion:

For Class I IVD device registration under Hong Kong MDACS, manufacturers need to submit a comprehensive set of technical documents that demonstrate the device’s safety, performance, and compliance with regulatory standards. These include detailed device descriptions, risk management plans, labeling, evidence of safety and performance, and a declaration of conformity, among other documents. Ensuring that the documents are complete and well-prepared can help streamline the registration process.

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