When registering a Class II in vitro diagnostic (IVD) medical device in Hong Kong under the Medical Device Administrative Control System (MDACS), you must prepare and submit several technical documents to demonstrate the device’s safety, efficacy, and compliance with regulatory standards. Below is a list of the essential technical document requirements:

Technical Document Requirements

1. Device Description

   • Provide a detailed description of the IVD, including its intended use, target population, and the specific analytes it is designed to detect or measure.
   • Include details about the device’s design, components, and operational principles.

2. Indications for Use

   • Clearly state the indications for use, specifying what conditions or diseases the device is intended to diagnose, prevent, or monitor.

3. Labeling and Instructions for Use (IFU)

   • Submit all labeling materials, including:
     • Product labels
     • Packaging information
     • Instructions for safe and effective use, which should include:
       • Step-by-step usage instructions
       • Warnings and precautions
       • Information about storage and handling

4. Quality Management System (QMS) Documentation

   • Evidence of compliance with quality management standards, such as ISO 13485. This may include:
     • Quality manual
     • Documented procedures and processes
     • Evidence of internal audits and management reviews
     • Certificates or declarations of compliance

5. Safety and Performance Data

   • Provide clinical data or performance evaluation results that support the safety and effectiveness of the device. This can include:
     • Results from clinical trials
     • Performance studies comparing the device with existing devices or standards
     • Literature reviews or summaries of relevant studies

6. Risk Management Documentation

   • A comprehensive risk management report in accordance with ISO 14971, including:
     • Identification of potential hazards associated with the device
     • Risk analysis and assessment
     • Risk control measures and residual risk evaluation
     • A summary of the risk management process and outcomes

7. Manufacturing Information

   • Detailed information about the manufacturing process, including:
     • A description of the manufacturing facility and its capabilities
     • Manufacturing controls and procedures
     • Specifications for materials and components used in the device

8. Validation and Verification Data

   • Data demonstrating that the device meets its design specifications and intended performance requirements, including:
     • Results from preclinical studies
     • Verification and validation testing results
     • Stability data, if applicable

9. Post-Market Surveillance Plan

   • Outline your plan for monitoring the device's performance after it is marketed, including:
     • Methods for collecting and analyzing post-market data
     • Processes for reporting adverse events and recalls, if necessary

10. Additional Documentation

    • Any other supporting documents that may be relevant to the device’s registration, such as:
      • Declarations of conformity
      • Environmental impact assessments (if applicable)
      • Ethical approvals for clinical studies

Summary

To register a Class II IVD in Hong Kong, you must submit comprehensive technical documentation that demonstrates the device’s safety, efficacy, and compliance with quality management standards. This includes device descriptions, labeling materials, QMS evidence, safety and performance data, risk management documentation, manufacturing information, and validation data. Ensuring thorough and accurate documentation will facilitate a smoother review process by the MDACS.

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