The time required for 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 at the time of submission. However, here’s a general overview of the expected timeline for the registration process:

Estimated Timeline for Class D Medical Device Registration

1. Preparation Stage:

   • Time Frame: 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.

2. Application Submission:

   • Once the application is prepared, it can be submitted to the Medical Device Division (MDD).

3. Initial Review Stage:

   • Time Frame: Typically takes about 2 to 4 weeks.
   • Activities: The MDD conducts a preliminary review to check if all required documents and information are included and meet submission standards.

4. Detailed Evaluation Stage:

   • Time Frame: This stage usually lasts 3 to 6 months, but it can extend longer depending on the complexity of the device and any additional requests for information.
   • Activities:
     • Evaluation of Technical Documentation: The MDD assesses the safety, efficacy, and quality of the device based on the submitted technical documents and clinical data.
     • Requests for Additional Information: If the MDD identifies any issues or requires further clarification, they will issue requests for additional information. The manufacturer must respond to these requests promptly.

5. Approval Stage:

   • Time Frame: After completing 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 preparation to receiving the registration certificate, the overall process can take approximately 4 to 12 months.

It is essential for manufacturers to plan accordingly and prepare comprehensive documentation to streamline the application process and minimize delays. Engaging with regulatory experts can also help navigate the process more efficiently.