The timeline for Class IV medical device registration under Hong Kong MDACS can vary depending on the complexity of the device and the completeness of the application. However, based on typical processes, here’s an overview of the general timeline:

1. Preparation of Documentation (2–6 Months)

Before you can submit an application, you need to prepare all the necessary documentation. This includes:

• Device Description and Technical Specifications: A comprehensive overview of the device, its intended use, design, and functionality.

• Clinical Evaluation Report (CER): Data from clinical trials or studies that support the safety and efficacy of the device.

• Risk Management Documentation: A report based on ISO 14971, demonstrating how potential risks have been identified and mitigated.

• ISO 13485 Certification: A copy of the manufacturer’s Quality Management System certification.

• Performance and Testing Data: Preclinical and clinical testing results.

• Instructions for Use (IFU) and Labeling: Documentation ensuring that the device labeling complies with Hong Kong's regulations.

This phase can take several months to complete, especially for Class IV devices, which require extensive clinical data and detailed risk management documentation.

2. Application Submission (1–2 Weeks)

Once you have compiled all the necessary documents, you will submit the application through the MDACS Online System or directly to the Hong Kong Department of Health (DH), depending on the method used. The submission process itself usually takes a few days to a week, depending on how quickly the application is prepared and submitted.

3. Application Review by the Department of Health (4–6 Months)

After submission, the Hong Kong Department of Health (DH) will begin the review process. For Class IV devices, this review is more comprehensive and rigorous due to the high-risk nature of the product.

• Document Review: The DH will check if the submitted documentation is complete and meets the regulatory requirements.

• Clinical and Risk Evaluation: Clinical data, risk management procedures, and performance tests will be thoroughly examined. For Class IV devices, this review can take time, especially if the DH needs to validate clinical trials or check if international standards are met.

• Manufacturing Facility Audits or Inspections: Depending on the complexity of the device, DH may request on-site inspections or audits of the manufacturing facilities, which could add to the timeline.

For Class IV devices, the review process can typically take 4 to 6 months. The DH may also request additional information during this phase, which could extend the timeline.

4. Issuance of Registration Certificate (1–2 Weeks)

Once the Department of Health is satisfied with the submitted documents and reviews, they will issue the registration certificate for the medical device. If the application is approved, this process usually takes about 1 to 2 weeks.

5. Post-Market Surveillance and Compliance

After the device has been registered, manufacturers must ensure compliance with post-market surveillance and reporting requirements. This includes adverse event reporting, annual renewals, and maintaining the device’s quality standards throughout its lifecycle.

Estimated Total Timeline: 6–12 Months

• Preparation of Documentation: 2–6 months

• Application Submission: 1–2 weeks

• Review by the Department of Health: 4–6 months

• Issuance of Registration Certificate: 1–2 weeks

In total, you can expect the entire process to take around 6 to 12 months, depending on the completeness of the application, the complexity of the device, and the efficiency of the review process.

Factors That Could Affect Timeline

• Completeness of the Application: Incomplete or insufficient documentation can cause delays as the DH may request additional information or clarification.

• Device Complexity: More complex devices with extensive clinical trials or new technologies may take longer for evaluation.

• Review Load at the Department of Health: The workload of the DH, including the number of pending applications and the complexity of other devices being reviewed, may impact the timeline.

• Need for Audits/Inspections: If the DH requests audits of manufacturing facilities or other inspections, this could extend the process.

Conclusion

The process of obtaining Class IV medical device registration under Hong Kong MDACS typically takes about 6 to 12 months, from the preparation of documentation to receiving the registration certificate. The process includes several phases such as preparing detailed technical documentation, submission, and a thorough review by the Hong Kong Department of Health. Manufacturers should plan accordingly, allowing ample time for each stage of the application process.

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