Applying for Class I IVD (in vitro diagnostic) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) is relatively streamlined. Class I devices are considered low-risk, so they generally follow simpler procedures compared to higher-risk categories. Here’s a step-by-step guide:

1. Confirm Class I Classification

• Verify that the IVD device qualifies as Class I based on the risk classification criteria outlined by the Medical Device Division (MDD) under Hong Kong’s Department of Health. Class I devices are typically low-risk, self-test devices without critical implications for diagnosis or treatment.

2. Prepare Required Documentation

• Application Form: Complete the MD-IVD-1 form for Class I IVD devices. This form is available on the Department of Health’s website.
• Technical File: Include a description of the device, its intended use, design, manufacturing information, and any labeling and instructions for use.
• Declaration of Conformity: A signed declaration stating the device meets relevant safety and performance requirements.
• Manufacturer's Information: Details about the manufacturer, including the quality management system (QMS) certification, like ISO 13485, if available.
• Supporting Evidence: Clinical data, risk assessments, and any existing certifications or approvals in other markets (such as CE marking).

3. Submit the Application

• Submit your completed application form and accompanying documents to the Medical Device Division (MDD) of Hong Kong's Department of Health.
• Fees for Class I devices are minimal or may not be required; verify any applicable fees with MDD before submission.

4. Await Review and Approval

• MDD will review the submission to ensure the device meets the safety and performance standards. For Class I devices, this review process is often faster than for higher-risk classes.
• Upon approval, the device will be listed in the Medical Device Administrative Control System (MDACS) database, allowing it to be legally marketed in Hong Kong.

5. Maintain Compliance

• After registration, manufacturers must ensure ongoing compliance with Hong Kong’s safety and performance standards, including reporting adverse events and any significant modifications to the device.

For further details or clarification, consulting with the MDD or a local regulatory expert can be beneficial, especially to keep up with any changes in the regulatory environment.