The processing time for Class I medical device MDACS registration in Hong Kong is typically about 12 weeks. This is the general timeline for the Department of Health (DH) to review and approve a Class I medical device registration, provided that all required documentation is complete and compliant with the regulatory standards.

Factors Affecting Processing Time

1. Completeness of the Application: If the submitted documents are complete and meet the necessary requirements, the process will proceed smoothly. Incomplete or incorrect submissions may lead to delays.

2. Device Type and Complexity: While Class I devices are generally considered low risk and have a simpler registration process, any complexities or issues regarding the device's safety or compliance may lead to longer processing times.

3. Review and Approval: After the submission, the Department of Health (DH) will assess the documentation, ensuring that the device complies with safety and regulatory standards. If additional information or clarification is required, this could extend the processing time.

Timeline Summary:

• Typical Processing Time: Around 12 weeks (3 months).

• Factors That May Extend Time: Incomplete applications, complex devices, or additional requests for information.

To avoid delays, it is important to ensure that all documents are accurate and meet the regulatory requirements before submission.

Contact Us：

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