The processing time for obtaining Class IV medical device registration under Hong Kong MDACS can vary depending on several factors, including the complexity of the device, the completeness of the application, and whether any additional information or clarification is required by the Hong Kong Department of Health (DH). However, a general timeframe can be outlined as follows:

Estimated Processing Time

• Initial Review: Typically, the initial review of a Class IV medical device registration application takes around 3 to 6 months.

  • This review period may be longer if there are issues with the submission, such as incomplete documentation or non-compliance with regulatory requirements.

  • The Hong Kong Department of Health (DH) will assess whether the device complies with the required safety, efficacy, and quality standards and may request additional information or clarification from the applicant during this period.

Factors Affecting Processing Time

1. Completeness of Documentation:

   • If all required documentation is submitted in complete form (technical file, risk management, clinical data, labeling, etc.), the processing time will generally be faster.

   • Incomplete or incorrect submissions can cause delays as the DH may need to request additional documents or explanations, extending the processing time.

2. Complexity of the Device:

   • Class IV devices are high-risk and typically require more comprehensive evaluation due to the potential impact on patient safety and health.

   • Devices with more complex designs, novel technologies, or significant clinical data may take additional time to evaluate.

3. Compliance with Standards:

   • If the device is compliant with international standards (e.g., ISO 13485, ISO 14971 for risk management, and ISO 10993 for biocompatibility), it can expedite the registration process.

   • Devices that require clinical trials or more extensive testing may take longer for the review process.

4. Backlog and Review Resources:

   • The processing time may vary based on the workload and resources available within the Hong Kong Department of Health (DH). High volumes of applications or resource constraints can lead to delays.

5. Post-Market Surveillance and Updates:

   • If the DH requires post-market surveillance data or if the device has had prior adverse events or recalls, this may affect the overall processing time as additional evaluations are required.

Possible Steps in the Process:

1. Pre-Submission Consultation (optional):

   • Manufacturers can request a pre-submission consultation with the DH to discuss their device’s regulatory requirements. This can help clarify requirements but does not typically affect the processing time directly.

2. Submission of Application:

   • Once the application is complete, it is submitted for review. The DH will acknowledge receipt and begin the evaluation.

3. Assessment and Review:

   • The DH will review all submitted documents, conduct risk assessments, and may request further clarification or additional documentation.

4. Approval or Request for Modification:

   • After the review is completed, the DH will either approve the registration, issue conditional approval (with further conditions), or request modifications to the application.

5. Issuance of Registration Certificate:

   • Once approved, the manufacturer will receive the official registration certificate for the device.

Conclusion

On average, it takes around 3 to 6 months to obtain Class IV medical device registration under Hong Kong MDACS, assuming all required documents are provided and the application meets the necessary regulatory requirements. However, the timeline can vary based on device complexity, completeness of the application, and the DH’s current workload. It is important for manufacturers to submit a comprehensive application to help expedite the process.

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