The time required to obtain Class I IVD medical device registration under Hong Kong MDACS typically takes around 1 to 3 months. However, this timeline can vary based on factors such as the completeness of the application, the complexity of the device, and the workload of the Hong Kong Department of Health (DoH).

Key Factors Influencing the Timeline:

1. Application Completeness: If the application is complete and all required documents are provided, the review process can be faster. Missing or incomplete information may lead to delays.
2. Device Complexity: Simpler, low-risk Class I IVD devices usually take less time for review compared to more complex devices, even within the Class I category.
3. Regulatory Body Workload: The time taken for approval can also depend on the Department of Health’s workload at the time of submission.
4. Additional Clarifications: If the DoH requests further clarification or additional documents, this may add extra time to the review process.

Typical Steps and Timeline:

1. Prepare and Submit Application: This phase is dependent on how long it takes the manufacturer to gather all necessary documents.
2. Document Review by DoH: This review process typically takes 4 to 8 weeks, during which the DoH will assess the application for compliance with regulatory requirements.
3. Approval or Request for Clarifications: If the application is complete and meets all regulatory requirements, approval can be granted relatively quickly. If clarifications or additional information are needed, this may add some extra time.

In general, if all goes smoothly, you can expect a registration timeline of 1 to 3 months.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn