The Class I medical device MDACS registration process in Hong Kong generally takes a few weeks to a few months, depending on the completeness of the application and the Department of Health's (DH) workload. However, a rough timeline for the process is as follows:

Timeline for Class I Medical Device MDACS Registration:

• Application Submission to Initial Review: 2-4 weeks (This period includes the time needed for the DH to check if the submitted application is complete and meets basic requirements).

• In-depth Review and Approval: 1-2 months (After the initial review, the DH assesses the technical documentation, including safety data, risk assessments, and compliance with local regulations).

• Issuance of Registration Certificate: Once approved, the registration certificate will be issued, which could take an additional 1-2 weeks depending on the final checks and certificate generation.

So, on average, the total process may take 4-6 weeks from submission to approval, but it's important to account for potential delays or requests for additional information.

Steps in the Review Process for Class I Medical Device MDACS Registration:

1. Application Submission:

   • Initial Application Review: Once you submit the application, the Department of Health will check the completeness of the documentation.

   • They ensure that all required fields are filled, documents are in order, and the device classification is accurate.

2. Review of Technical Documentation:

   • The DH will evaluate the technical documents, including the device description, risk management file, labeling, and clinical evidence (if applicable).

   • The risk management file is closely examined to ensure that the device does not pose any significant safety or health risks.

   • The ISO 13485 certification (if applicable) may be assessed to verify the manufacturer's adherence to international quality management standards.

3. Compliance Check:

   • The DH ensures that the device complies with Hong Kong's medical device regulations and checks for conformity with international standards (such as ISO standards or EU MDR, where applicable).

   • The DH may request clarifications or additional documentation if any discrepancies are found.

4. Issuance of Registration Certificate:

   • After a thorough review, if the device meets all regulatory requirements, the DH will issue the registration certificate.

   • This certificate formally approves the device for sale and use in Hong Kong.

5. Post-Registration Follow-up (if necessary):

   • If any post-registration compliance checks are required or if the DH issues further queries, you will be notified.

   • This step may involve providing additional information or updating the registration with new details (e.g., updated labeling or risk assessments).

Additional Notes on the Review Process:

• Incomplete Applications: If your application is missing documents or if the device description or classification is unclear, it could cause delays in the review process.

• Requests for Additional Information: The DH may request more detailed information on the device's safety performance or clarification on technical specifications, which could extend the timeline.

• Local Responsible Person (LRP): If you are based outside Hong Kong, having a Local Responsible Person (LRP) ensures that communication with the DH is smooth, and can potentially speed up the process.

In general, being thorough in your initial application submission and promptly responding to any DH requests will help speed up the registration process.

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