The processing cycle for Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) generally involves several phases, from application submission to approval. Here’s a breakdown of the key stages and expected timelines in the processing cycle:

1. Preparation Phase

• Duration: Several weeks to several months
• During this phase, you will gather and prepare all the necessary documentation required for the application, including:
  • Device description and intended use
  • Labeling and Instructions for Use (IFU)
  • Quality Management System (QMS) evidence
  • Safety and performance data
  • Risk management documentation
  • Manufacturer information

2. Online Application Submission

• Duration: 1 day
• Once all documentation is prepared, you can submit your application through the MDACS online submission system. This includes completing the application form, uploading required documents, and paying the registration fee.

3. Initial Review by MDACS

• Duration: Approximately 10 to 14 days
• After submission, the MDACS will conduct an initial review to ensure that all required documents have been submitted and that the application is complete.
• If the application is incomplete or lacks necessary information, MDACS may request additional information or clarification during this stage.

4. Technical Review and Evaluation

• Duration: Approximately 60 to 90 days
• Once the application passes the initial review, it will undergo a detailed technical review by the Department of Health (DH). This phase includes:
  • Assessment of safety and performance data
  • Evaluation of the QMS documentation
  • Review of risk management information
• The DH may consult external experts or stakeholders during this review if necessary.

5. Response to Queries (if needed)

• Duration: Varies (typically 10 to 30 days)
• If the DH identifies any issues or requires additional information during the technical review, they will issue a query. You will need to respond promptly with the requested information.
• The time taken for this step can vary based on the complexity of the queries and how quickly you provide the necessary information.

6. Approval and Issuance of Registration Certificate

• Duration: 1 day
• If the application is approved, you will receive a registration certificate for your Class II IVD, which allows you to market and distribute the device in Hong Kong.

7. Post-Market Surveillance Preparation

• Ongoing
• After registration, you will need to implement a post-market surveillance plan to monitor the device's performance and report any adverse events or incidents as required by the regulatory authority.

Total Estimated Timeframe

• Overall Processing Cycle: The entire processing cycle from preparation to approval generally takes around 3 to 6 months, depending on the complexity of the device, the completeness of the application, and the responsiveness to any queries from the DH.

Summary

The processing cycle for Class II IVD registration in Hong Kong includes preparation, online submission, initial review, technical evaluation, and approval, typically spanning 3 to 6 months. Being thorough in your application preparation and responsive to any inquiries can help expedite the process.