The process of obtaining Class I medical device MDACS registration in Hong Kong typically takes approximately 4 to 6 weeks. This timeline can vary depending on the completeness and accuracy of the application, the volume of applications being processed by the Department of Health (DH), and any additional information or clarifications needed during the review.

Factors That May Influence Processing Time:

1. Completeness of the Application: If all the required documents are submitted correctly, the process will proceed more smoothly and quickly.

2. Volume of Applications: The DH's current workload may impact the time it takes to process your application.

3. Clarification Requests: If the DH requires further clarification or additional documentation, this could extend the review time.

Once the application is submitted, the DH will review the documents and assess whether the product meets the necessary regulatory requirements. If everything is in order, the registration certificate will typically be issued within the 4- to 6-week timeframe.

For a more accurate estimate of the processing time for your specific case, it's recommended to check the status of your application or consult directly with the Department of Health.

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