The time it takes to obtain Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) can vary based on several factors, including the complexity of the device, the completeness of the application, and the regulatory workload. However, here’s a general overview of the expected timeline:

Estimated Timeline for Class D Medical Device Registration

1. Preparation Stage:

   • Duration: This can take anywhere from a few weeks to several months depending on how quickly the manufacturer can gather the necessary documentation, conduct clinical evaluations, and ensure compliance with quality management systems (such as ISO 13485).

2. Application Submission:

   • After preparing the application and supporting documents, the submission can be made to the Medical Device Division (MDD).

3. Initial Review Stage:

   • Duration: Typically takes about 2 to 4 weeks.
   • Activities: The MDD conducts an initial review to check if all required documents and information are included and meet submission standards.

4. Detailed Evaluation Stage:

   • Duration: This stage usually lasts 3 to 6 months, but it can take longer depending on the complexity of the device and any additional requests for information.
   • Activities:
     • The MDD will assess the safety, efficacy, and quality of the device based on the submitted technical documents and clinical data.
     • They may request additional information if necessary, which can further extend the timeline.

5. Approval Stage:

   • Duration: After the detailed evaluation, if the application is approved, this typically takes 1 to 2 weeks.
   • Activities: The MDD issues a registration certificate and assigns a registration number to the device.

Summary of Overall Process Duration

• Total Time Frame: From the initial preparation of documents to receiving the registration certificate, the overall process can take approximately 4 to 12 months.

Conclusion

To ensure a smoother process and minimize potential delays, it is crucial for manufacturers to prepare comprehensive documentation and adhere to the guidelines set forth by the Hong Kong Department of Health. Engaging with regulatory experts or consultants can also be beneficial in navigating the registration process efficiently.

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