The time frame for applying for Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS) can vary depending 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 time frame and the stages of the review process:

Time Frame for Class D Medical Device Registration

1. Preparation Stage:

   • Time Frame: This stage can take a few weeks to several months depending on how quickly the manufacturer can gather the necessary documentation, conduct clinical evaluations, and prepare the application.
   • Activities: Compiling technical documentation, clinical data, and ensuring compliance with quality management systems.

2. Application Submission:

   • Once the application is complete, 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 the 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 Stages in the Review Process

1. Preparation Stage: Weeks to months (document preparation and quality checks).
2. Application Submission: Submit application form and documents to the MDD.
3. Initial Review Stage: 2 to 4 weeks (preliminary assessment of submission completeness).
4. Detailed Evaluation Stage: 3 to 6 months (in-depth assessment of technical and clinical data).
   • Requests for Additional Information: May extend the timeline if needed.
5. Approval Stage: 1 to 2 weeks (issuance of registration certificate upon approval).

Total Time Frame

• Overall Process: The total time from initial preparation to receiving the registration certificate can range from approximately 4 to 12 months, depending on the factors mentioned above.

It’s 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 in navigating the process more efficiently.

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