The typical timeline for obtaining Class III medical device MDACS registration in Hong Kong is approximately 12 weeks from the date of submission, assuming that the application is complete and there are no significant issues during the review process. Here's a breakdown of the steps involved and the corresponding timelines:

1. Preparation and Documentation (Variable)

• Preparation Time: The time required to gather all necessary documents, such as technical files, clinical data, risk management reports, and compliance certifications, depends on the complexity of the device and the completeness of the materials.

• It is important to ensure all required documents are accurate and thorough to avoid delays during the review process.

2. Application Submission

• Submission Process: Once all documents are ready, the application is submitted through the Medical Device Information System (MDIS) online platform.

3. Acknowledgment of Receipt (2 Weeks)

• Acknowledgment: After submission, the Hong Kong Department of Health (DoH) will acknowledge receipt of the application and provide an application number. This usually happens within 2 weeks.

4. Application Review (Approximately 12 Weeks)

• Review Time: The DoH typically takes about 12 weeks to process the application and review the provided documentation. This review period may vary depending on the complexity of the device and the completeness of the application.

• During this time, the DoH evaluates the safety, efficacy, and quality of the device, as well as compliance with local regulations and standards.

5. Approval and Notification (1-2 Weeks)

• Decision Notification: After the review is completed, the manufacturer will receive notification of the outcome of the application. If the application is approved, a listing certificate will be issued.

• The notification of approval typically occurs within 1-2 weeks after the review process is complete.

Total Timeline:

• Preparation and Documentation: Variable (depends on the applicant's readiness)

• Acknowledgment of Receipt: 2 weeks

• Application Review: Approximately 12 weeks

• Decision Notification: 1-2 weeks

In total, the process from submission to approval typically takes around 14 to 16 weeks, or approximately 3-4 months. This timeline may be longer if there are issues with the application or if additional information or clarifications are requested.

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