The process for applying for Class IV medical device registration under Hong Kong MDACS typically involves several stages, and the time required for the entire process can vary depending on several factors such as the complexity of the device, completeness of the documentation, and the responsiveness of the applicant.

Timeline for Class IV Medical Device Registration

The estimated processing time for Class IV medical device registration under MDACS generally ranges from 6 to 12 months. However, this timeline can be longer if there are delays in document submission, clarifications, or additional requests from the Hong Kong Department of Health (DH).

Stages of the Review Process

The application review process consists of several stages:

1. Submission and Initial Evaluation (1–2 Months)

• Document Check: After submission, the DH will conduct an initial evaluation to ensure that all necessary documents and fees are submitted correctly. This is to confirm whether the application is complete and meets the required standards.

• Completeness Review: The DH will verify that all technical documentation, clinical data, and regulatory certifications are in order. This stage also includes an evaluation of whether the manufacturer’s quality management system complies with ISO 13485 standards.

• Time Frame: This stage typically takes around 1 to 2 months.

2. Risk Assessment and Technical Review (2–4 Months)

• Clinical Data Review: A major component of this stage is the review of the clinical evaluation report (CER) and any clinical trials or performance data provided. The DH will assess whether the device meets safety and effectiveness requirements.

• Risk Management Assessment: The DH reviews the manufacturer’s risk management plan based on ISO 14971 to ensure that all potential risks are properly identified, controlled, and mitigated.

• Review of Labeling and IFU: The DH will also check that the device's labeling and instructions for use (IFU) comply with Hong Kong's regulatory requirements.

• Inspection (if applicable): In some cases, the DH may request an inspection of the manufacturing site or verify compliance with the quality management system (e.g., through ISO 13485 audits).

• Time Frame: This stage generally takes 2 to 4 months, depending on the complexity of the device and the quality of the submitted documentation.

3. Clarification and Additional Information (Varies)

• If the DH identifies any issues or missing information during the review process, they may issue a request for clarification or additional data. This could relate to clinical data, technical specifications, or other regulatory requirements.

• The response time to such requests can impact the overall timeline. It is crucial to provide the requested information promptly to avoid delays.

• Time Frame: This stage varies depending on the time required to gather and submit the requested documents. It could add several weeks to a few months to the overall processing time.

4. Decision and Issuance of Registration Certificate (1–2 Months)

• Once the DH completes its evaluation and confirms that the device meets all safety and regulatory requirements, the registration certificate will be issued.

• The registration certificate is usually valid for five years. In some cases, if the application has any outstanding conditions or if the device requires further evaluation, additional time may be needed for final approval.

• Time Frame: This stage typically takes 1 to 2 months.

5. Post-Market Surveillance and Compliance (Ongoing)

Once the device is registered, the manufacturer must comply with post-market surveillance requirements, including:

• Adverse event reporting

• Market monitoring

• Corrective actions (if needed)

This is an ongoing obligation, but it doesn’t affect the timeline for obtaining initial registration.

Total Estimated Time: 6–12 Months

In summary, the total processing time for Class IV medical device registration under Hong Kong MDACS is typically around 6 to 12 months, depending on factors such as the completeness of the submission, the complexity of the device, and the responsiveness of the applicant in addressing any additional requests from the Department of Health.

Key Factors That Can Affect the Processing Time

1. Completeness of the Application: Ensuring that all required documents are included and accurate can help avoid delays.

2. Complexity of the Device: Devices that are more complex (e.g., implantable devices or diagnostic devices) may require more time for review, especially if more clinical data is needed.

3. Requests for Additional Information: If the DH requires more data or clarification, this can add significant time to the process.

4. Inspection or Audit: If an on-site inspection of the manufacturing facility or a quality management system audit is required, this may add to the overall timeline.

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