Class I IVD (in vitro diagnostic) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) is a voluntary process, intended to ensure that low-risk IVD devices meet safety, quality, and performance standards. This registration is handled by the Department of Health’s Medical Device Division (MDD). Here is a detailed guide to the procedures and steps for registering a Class I IVD medical device:

Step 1: Confirm Device Classification

• Classification Verification: First, confirm that the device qualifies as a Class I IVD device based on the MDD’s classification criteria. Class I typically includes low-risk IVDs used for self-testing or non-critical functions.

Step 2: Prepare Documentation and Forms

Gather and complete the necessary documentation, which includes:

1. Application Form (MD-IVD-1): Complete this form, specifically designed for Class I IVD devices. It’s available on the Department of Health’s website.

2. Technical File Documentation: Compile a comprehensive technical file, including:

   • Device Description: Provide a detailed description, intended use, and any specific functionalities.
   • Labeling and Instructions for Use: These should detail proper use, warnings, and any necessary safety information.
   • Risk Assessment: Conduct and document a risk assessment according to recognized standards to identify and manage any potential risks.

3. Declaration of Conformity: Include a signed Declaration of Conformity, stating that the device complies with recognized safety and performance standards.

4. Manufacturer’s Information:

   • Quality Management System (QMS) Certification: If available, include ISO 13485 or equivalent QMS certification to demonstrate compliance with manufacturing standards.
   • Manufacturer Details: Information about the manufacturer, including contact details and an overview of their quality control procedures.

5. Evidence of Safety and Performance: Include any relevant clinical data, test reports, or regulatory approvals from other markets, such as CE marking (Europe) or FDA clearance (United States), to strengthen the application.

Step 3: Submit the Application

• Submission Process: Submit the MD-IVD-1 form and all supporting documents to the Medical Device Division (MDD) in Hong Kong.
• Fees: Confirm if there are any applicable fees for Class I IVD registration, as these fees are generally lower or may be waived for Class I devices.

Step 4: Await Review and Approval

• MDD Review: The MDD will review the application to ensure that the device meets MDACS requirements. Since Class I devices are low-risk, the review process is generally faster and less intensive compared to higher-risk classes.
• Listing on MDACS Database: Once approved, the device will be listed on the MDACS database, allowing it to be marketed in Hong Kong. This listing verifies that the device complies with local safety and performance standards.

Step 5: Post-Registration Compliance

After receiving approval, manufacturers have ongoing responsibilities:

• Post-Market Surveillance: Monitor the device’s performance in the market, report any adverse events, and maintain records of complaints or issues.
• Notification of Modifications: Inform the MDD of any significant changes to the device, such as modifications in design, labeling, or intended use, to ensure continued compliance.

Summary of Key Steps

1. Confirm Class I IVD classification.
2. Complete MD-IVD-1 application form.
3. Prepare a technical file, including device description, risk assessment, and safety documentation.
4. Submit the application to MDD along with necessary supporting documents.
5. Await MDD review and approval.
6. Comply with post-market requirements, including monitoring and reporting.

Benefits of MDACS Registration

While MDACS registration for Class I IVD devices is voluntary, it can enhance market acceptance and user trust in Hong Kong. Registered devices are recognized as meeting Hong Kong's quality and safety standards, which can be beneficial in healthcare settings and for consumers.