The process for Class I IVD medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) involves several steps, including preparing documentation, submitting applications, and maintaining compliance with local regulations. Here's a detailed overview of the registration process and the steps involved:

Steps for Class I IVD Medical Device Registration under Hong Kong MDACS:

1. Prepare Necessary Documentation

Before submitting the registration application, ensure you have all the required documentation ready. These documents include:

• Device Description: Detailed information about the device, including its intended use, design, and functionality.
• Conformity with Standards: Proof that the device complies with international standards, such as ISO 13485 (for quality management systems) and ISO 14971 (for risk management).
• Risk Assessment: Documentation of the risk analysis and management for the device, demonstrating that the risks associated with the device are minimized.
• Performance Data: Clinical or non-clinical performance data that demonstrate the device’s safety, efficacy, and accuracy (if applicable).
• Labeling: A copy of the device’s labeling, including instructions for use (IFU), user manuals, and packaging details.
• Manufacturing Information: Details about the manufacturer and the production process, especially if the device is manufactured overseas.
• Authorized Representative: If the manufacturer is located outside Hong Kong, they must appoint an authorized representative in Hong Kong to submit the application.

2. Submit Application to the Hong Kong Department of Health

Once all documents are prepared, the manufacturer (or their authorized representative) submits the registration application to the Hong Kong Department of Health (DoH). The submission should include:

• Completed Registration Form: Fill out the official application form for Class I IVD medical device registration.
• Supporting Documentation: Attach all the required documents (as listed above) to support the application.
• Fee Payment: Pay the registration fee, which is specified by the Hong Kong Department of Health.

The application can be submitted online through the MDACS system or in paper form, depending on the requirements.

3. Review by the Hong Kong Department of Health

The Department of Health will review the application to ensure that all required information is provided and that the device complies with the relevant safety, efficacy, and quality standards. The review process involves:

• Document Check: Ensure that all the necessary documentation has been submitted and is complete.
• Compliance Review: Verify that the device meets all the applicable regulatory requirements, including those for performance, labeling, and risk management.

4. Decision on Registration

Once the Department of Health has reviewed the application, they will issue a decision on whether the device can be registered.

• If the application is approved, the device will be officially registered under the MDACS.
• If the application is rejected, the manufacturer will be notified, and they may need to address any issues or resubmit the application.

5. Issuance of Registration Number

If the registration is approved, a registration number will be assigned to the device. The manufacturer (or authorized representative) must ensure that this number is displayed on the product labeling and associated documentation.

6. Post-Registration Obligations

Once the device is registered, manufacturers must meet ongoing requirements to maintain the registration. These include:

• Post-Market Surveillance: Monitor the safety and effectiveness of the device once it is on the market.
• Adverse Event Reporting: Report any adverse events, malfunctions, or safety issues to the Hong Kong Department of Health.
• Annual Renewal: The device’s registration must be renewed every 5 years. This involves submitting updated documents, confirming compliance, and paying the renewal fee.
• Changes to the Device: Notify the Hong Kong Department of Health of any significant changes to the device, such as modifications to the design, intended use, or manufacturing process.

7. Ongoing Compliance and Inspections

• Quality Management System (QMS): Manufacturers must maintain compliance with quality management standards, especially ISO 13485, and keep up with any changes or updates.
• Inspections: The Hong Kong Department of Health may conduct inspections to verify that the device continues to meet regulatory standards.

Summary of Key Steps:

1. Prepare Documentation: Ensure you have all required documents, such as device description, risk assessment, performance data, and labeling.
2. Submit Application: Complete the registration form and submit it with the supporting documentation and fee to the Hong Kong Department of Health.
3. Department Review: The Hong Kong Department of Health reviews the application to verify compliance with regulatory requirements.
4. Registration Decision: If approved, the device is registered, and a registration number is issued.
5. Post-Registration: Ensure compliance with post-market surveillance, renew the registration every 5 years, and report any changes to the device.

This process ensures that Class I IVD devices are registered and compliant with Hong Kong’s medical device regulations, allowing them to be legally marketed and sold in the territory.