The processing time for Class I medical device MDACS registration in Hong Kong typically takes about 4 to 6 weeks. This timeline may vary depending on several factors such as:

1. Completeness of the Application: If the required documentation is complete and in order, the review process will be faster. Missing or incomplete information can delay the processing time.

2. Review Complexity: Although Class I devices are generally low-risk and can be self-declared by the manufacturer, the complexity of the product or any need for additional information can extend the processing time.

3. Volume of Applications: The workload at the Department of Health (DH) and the number of applications being processed at any given time can influence the time it takes for the DH to review and approve the application.

Key Steps in the Review Process:

1. Application Submission: After submitting the required documents, the DH begins reviewing the information provided.

2. Assessment of Documentation: The DH checks the completeness of the application and assesses the safety and quality compliance based on local regulations.

3. Approval/Issuance of Registration Certificate: Once everything is in order, the DH issues the registration certificate.

If any issues arise, such as missing documents or the need for further clarification, it could cause delays. For more accurate information, contacting the Department of Health (DH) directly or checking the MDACS portal may provide specific updates for your device.

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