For Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), the Department of Health’s Medical Device Division (MDD) has outlined specific requirements to ensure that low-risk devices meet safety, performance, and quality standards. Here are the main requirements for registering a Class I IVD medical device:

1. Device Classification as Class I IVD

• Risk Classification: The device must be confirmed as a Class I IVD under MDACS. This class includes low-risk IVD devices, such as those used for self-testing or for non-critical functions.
• Risk Assessment: The device should undergo a documented risk assessment, ensuring it poses minimal risk to the user and public.

2. Technical Documentation

• Device Description: A complete description of the device, including its intended use, design features, and technical specifications.
• Labeling and Instructions for Use: All labeling should be clear and comprehensive, detailing proper use, safety precautions, and relevant instructions. This includes any warnings, usage limitations, and instructions for handling and storage.
• Risk Analysis and Management: Conduct a risk assessment to identify any potential hazards and outline control measures. This documentation should follow internationally recognized standards like ISO 14971, where applicable.
• Clinical and Performance Data: Evidence supporting the device's safety and performance should be included, such as clinical data or performance testing results.

3. Quality Management System (QMS) Documentation

• Manufacturer QMS Certification: Although not mandatory for Class I IVD devices, the MDD strongly recommends providing ISO 13485 certification or equivalent, as it demonstrates the manufacturer’s adherence to quality standards.
• Manufacturing Information: Include details on the manufacturing process, including information about quality control procedures that ensure the consistency and reliability of the device.

4. Declaration of Conformity

• Manufacturer's Declaration: A formal, signed Declaration of Conformity from the manufacturer, affirming that the device meets all relevant safety and performance standards for a Class I IVD under MDACS.

5. Manufacturer Information

• Details of the Manufacturer: Provide the full name, address, and contact details of the manufacturer.
• Authorized Representative in Hong Kong (if applicable): If the manufacturer is based outside Hong Kong, a local authorized representative’s details should also be included to facilitate communication with the MDD.

6. Completed Application Form (MD-IVD-1)

• Form Submission: The MD-IVD-1 form is specifically for Class I IVD devices and is available on the MDD website. Ensure the form is filled accurately with complete and current information.
• Supporting Documents: Attach all required technical documentation, declarations, and manufacturer information to the form for submission.

7. Post-Market Surveillance and Compliance

• Post-Market Monitoring Plan: A plan to monitor the device’s performance once it’s in the market is required. This includes systems for tracking adverse events, complaints, and corrective actions.
• Adverse Event Reporting: Any adverse events or significant device issues must be reported to the MDD to maintain compliance.
• Notification of Changes: Notify MDD of any significant changes to the device, such as modifications to its design, intended use, or labeling.

8. Fees (if applicable)

• Application Fees: Fees for Class I IVD registration are typically lower or may not apply. Check with the MDD for confirmation regarding fees for your device classification.

Summary of Requirements for Class I IVD Registration

1. Confirm classification as Class I IVD.
2. Compile comprehensive technical documentation.
3. Prepare risk assessment and performance data.
4. Submit manufacturer QMS certification, if available.
5. Provide a Declaration of Conformity.
6. Complete the MD-IVD-1 application form.
7. Implement a post-market surveillance plan.
8. Ensure ongoing compliance and notification of changes.

Although MDACS registration is voluntary for Class I IVDs, fulfilling these requirements can enhance credibility and market acceptance in Hong Kong.

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