The processing time for Class A medical device registration under Hong Kong's MDACS (Medical Device Administrative Control System) is typically:

📅 Processing Time: 1 to 3 months

This time frame depends on several factors:

• Completeness and accuracy of the submitted application and documents (MD-TRF form, device description, labeling, etc.).

• MDD's current workload: The Medical Device Division (MDD) reviews applications on a first-come, first-served basis. The time to process may vary depending on their backlog.

• Clarifications or additional information: If MDD requires further details or clarification, the processing time can be extended.

🌟 Typical Timeline Breakdown:

1. Initial Review: The MDD reviews the application for completeness and regulatory compliance. This can take around 1–2 months.

2. Approval and Listing: If everything is in order, the device will be listed in the MDACS registry, which can take another 2–3 weeks.

💡 How to Speed Up the Process:

• Ensure complete documentation: Incomplete or incorrect submissions may lead to delays.

• Work with a Local Responsible Person (LRP): If the manufacturer is based outside Hong Kong, appoint an LRP well in advance to avoid any delays in application processing.

• Provide clear and accurate information: Double-check the labeling, device description, and classification justification for accuracy.

Would you like a checklist to ensure everything is prepared for a smooth application process?

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