Before applying for Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), several key preparatory steps are essential to ensure a smooth and successful application process. Proper preparation helps to avoid delays, rejections, or requests for additional information from the Medical Device Control Office (MDCO). Below are the important steps to take before submitting the application:

1. Verify Eligibility and Classification

• Determine Device Class: Confirm that your device falls under Class C according to MDACS guidelines. This is essential, as the classification impacts the requirements for registration.
  • Class C devices are medium- to high-risk devices (e.g., surgical lasers, dialysis machines) and may require more extensive documentation compared to lower classes.
• Understand MDACS Regulations: Ensure that your device complies with Hong Kong’s medical device regulatory framework. Review the Essential Principles of Safety and Performance that apply to your device.

2. Establish a Quality Management System (QMS)

• ISO 13485 Certification: Make sure that your company’s manufacturing processes comply with the ISO 13485 quality management system (QMS) standard, which is a requirement for medical device manufacturers. This certification demonstrates that your company follows international standards for designing, manufacturing, and maintaining medical devices.
  • If your company does not yet have ISO 13485 certification, it is critical to establish the necessary procedures and obtain the certification before applying.

3. Compile Technical Documentation

• Prepare Full Technical File: Assemble a comprehensive technical dossier for the device, which includes the following:
  • Device description: Clearly explain the design, intended use, and technical specifications.
  • Risk management report: Based on ISO 14971, detail the device’s risk assessment and control measures.
  • Clinical evidence: Gather data from clinical trials or studies demonstrating the safety and effectiveness of the device.
  • Testing reports: Include testing reports, such as biocompatibility (ISO 10993), electrical safety (IEC 60601), and software validation (if applicable).
  • Labeling and Instructions for Use (IFU): Prepare labeling and IFUs that comply with MDACS standards, ensuring that they are provided in both English and Chinese.
• Conformity Assessment Evidence: Ensure that all certificates proving compliance with international standards (e.g., CE marking, US FDA approval) are ready for submission.

4. Identify and Appoint a Local Authorized Representative (LAR)

• LAR Requirement: If the manufacturer is located outside of Hong Kong, you must appoint a Local Authorized Representative (LAR) in Hong Kong.
  • The LAR acts on behalf of the manufacturer for regulatory matters in Hong Kong, including registration, adverse event reporting, and post-market surveillance.
  • Ensure that the LAR has the necessary expertise and is prepared to fulfill their responsibilities throughout the device’s lifecycle.

5. Conduct Product Testing and Verification

• Product Testing: Verify that all necessary pre-market tests have been completed, and obtain relevant certifications. Testing may include:
  • Biocompatibility Testing: Based on ISO 10993, this ensures that the device’s materials are safe for use in or on the human body.
  • Electrical Safety Testing: For electro-medical devices, ensure compliance with IEC 60601 standards for electrical safety.
  • Sterilization Validation: For devices that require sterilization, ensure that validation of sterilization processes has been completed.
  • Software Validation: If the device contains software, verify that it complies with IEC 62304 (software lifecycle processes) and any relevant cybersecurity standards.

6. Prepare Post-Market Surveillance (PMS) Plan

• PMS Plan: Develop a Post-Market Surveillance (PMS) plan outlining how you will monitor the safety and performance of the device once it is on the market. This plan should include:
  • Procedures for collecting performance data and user feedback.
  • Methods for identifying and reporting adverse events or device failures.
  • A recall strategy for managing defective products if necessary.

7. Check Documentation for Completeness and Accuracy

• Complete and Accurate Submission: Review all documentation to ensure that it is complete, accurate, and well-organized. Incomplete or inaccurate submissions can delay the application process.
  • Ensure that all documents are up-to-date and compliant with MDACS requirements.
  • Cross-check that all claims made about the device (e.g., performance, safety) are supported by appropriate evidence (clinical studies, test reports, etc.).
  • Essential Principles Checklist: Complete the checklist that demonstrates the device’s compliance with the Essential Principles of Safety and Performance, referencing the relevant parts of your documentation.

8. Plan for Application Fees

• Budget for Fees: Be aware of the application fees associated with Class C medical device registration. Ensure that you have budgeted for the registration fee and any associated costs (e.g., testing, certifications, etc.).
  • The fees for Class C devices are typically higher than those for lower-risk devices due to the increased complexity of the assessment.

9. Prepare for Communication with MDCO

• Communication and Queries: Be prepared to communicate with the MDCO during the review process. They may request additional information or clarification on certain aspects of your submission.
  • Ensure that your team or your LAR is responsive and able to provide the requested information in a timely manner to avoid delays.

10. Consider Local Market Readiness

• Market Preparation: In parallel with regulatory submission, consider preparing for market entry in Hong Kong:
  • Plan your distribution channels.
  • Ensure that your supply chain is ready to handle logistics and compliance with local requirements (e.g., labeling in both English and Chinese).
  • Educate healthcare providers or end-users about the device’s safe and effective use through training or instructional materials.

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