Registering a Class I In Vitro Diagnostic (IVD) medical device under Hong Kong's Medical Device Administrative Control System (MDACS) is a structured but voluntary process overseen by the Medical Device Division (MDD) of the Department of Health. Although registration is not mandatory for Class I IVD devices (low-risk), it enhances credibility and market access. Here’s a comprehensive guide to the procedures, required documents, and important considerations:

1. Procedures for Class I IVD Registration under MDACS

Step 1: Confirm Classification as Class I IVD

• Classification Verification: Ensure your device qualifies as Class I IVD. This classification includes low-risk devices used for routine diagnostics or self-testing, typically without high risk to users.

Step 2: Prepare Required Documents

• Compile all necessary documents as detailed below, which include technical documentation, declarations, and manufacturer information.

Step 3: Submit the Application

• Submit the MD-IVD-1 form (specific to Class I IVD devices) and supporting documents to the MDD. Applications can be mailed or delivered in person to the MDD’s office in Hong Kong.

Step 4: Review and Approval by MDD

• The MDD will review the submission to ensure compliance with MDACS requirements. For Class I devices, the review is generally quicker than for higher-risk categories.

Step 5: Post-Market Surveillance and Maintenance

• After approval, implement post-market monitoring to maintain compliance, monitor device safety, and report any adverse events as required by the MDD.

2. Required Documents for Class I IVD Registration

Here’s a detailed breakdown of documents needed for submission:

a. Application Form (MD-IVD-1)

• This form is the primary document for Class I IVD device registration and should be completed with accurate device details.

b. Technical Documentation

• Device Description: Provide a comprehensive overview, including device design, specifications, and intended use.
• Labeling and Instructions for Use: Include copies of labeling, instructions, warnings, and any other necessary information for safe and proper device usage.
• Risk Assessment and Management: A documented risk assessment should outline any identified risks, their management, and control measures in accordance with recognized standards (such as ISO 14971).
• Evidence of Safety and Performance: Submit clinical data, validation reports, and any other evidence supporting the device’s safety and effectiveness. If the device has approvals from other regulatory bodies, such as CE marking or FDA clearance, these should be included.

c. Declaration of Conformity

• A formal, signed declaration from the manufacturer stating that the device complies with the necessary safety and performance standards for a Class I IVD device.

d. Quality Management System (QMS) Documentation

• ISO 13485 Certification (Optional): While not mandatory for Class I devices, providing QMS certification (such as ISO 13485) is recommended as it strengthens the application by demonstrating quality assurance in manufacturing.
• Manufacturer’s Quality Control Procedures: Include details about the manufacturer’s quality management practices to ensure device consistency and reliability.

e. Manufacturer Information

• Details of Manufacturer: Provide the full name, address, and contact details of the manufacturer.
• Authorized Representative (for foreign manufacturers): If the manufacturer is not based in Hong Kong, appoint a local representative and provide their contact details to facilitate communication with the MDD.

3. Important Considerations for Class I IVD Registration

a. Application Completeness and Accuracy

• Ensure all forms and documentation are accurate, complete, and up-to-date to avoid delays in the review process. Missing information can lead to requests for additional details, which can extend the timeline.

b. Post-Market Surveillance Obligations

• Monitoring and Adverse Event Reporting: After approval, maintain a system to monitor the device’s safety and effectiveness. Report any adverse events to the MDD promptly.
• Device Modifications: Notify the MDD of any significant changes to the device, such as adjustments in design, labeling, or intended use, which might impact safety or performance.

c. Time and Cost Considerations

• Time: The entire registration process typically takes about 2–6 months, depending on the complexity of the device and the completeness of the application.
• Cost: Class I devices generally incur minimal or no application fees under MDACS, but confirm this with the MDD.

d. Local Market Preferences

• Although registration for Class I IVD devices is voluntary, it may enhance market acceptance, as healthcare institutions in Hong Kong often prefer MDACS-registered devices.

Summary of the Registration Process

1. Verify Classification: Confirm the device is Class I IVD.
2. Prepare Documentation: Compile and complete all required forms and technical documents.
3. Submit Application: Submit the MD-IVD-1 form and documents to the MDD.
4. Review and Approval: The MDD reviews the application for compliance.
5. Maintain Compliance: Monitor device safety and report significant modifications or adverse events.

Following these steps ensures a smoother registration process and enhances the device’s marketability in Hong Kong. For up-to-date requirements or any specific inquiries, contacting the MDD directly is advised.

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