In Hong Kong, Class I IVD (In Vitro Diagnostic) medical devices are those considered to be low-risk under the Medical Device Administrative Control System (MDACS), overseen by the Department of Health’s Medical Device Division (MDD). The MDACS system provides a structured process to ensure the safety, quality, and performance of medical devices before they can be marketed. Here’s an overview of Class I IVD medical device registration and the application process:

What is Class I IVD Medical Device Registration?

Class I IVD medical devices in Hong Kong are generally low-risk products intended for in vitro diagnostic purposes. These could include diagnostic devices that do not involve critical or life-supporting functions. Examples might be devices used for routine blood glucose monitoring, urine testing strips, or other self-test diagnostics with minimal risk.

The MDACS registration is a voluntary system that enables manufacturers to register their devices for enhanced market access. While not mandatory, registration is often seen as advantageous since healthcare institutions in Hong Kong may prefer registered devices, and it signals to users that the device meets recognized safety and performance standards.

Steps to Apply for Class I IVD Medical Device Registration under MDACS

Here’s a step-by-step guide to applying for registration:

1. Verify Classification as Class I IVD

• Ensure that your device qualifies as Class I IVD according to the classification criteria provided by the MDD. This class covers low-risk devices only; if the device has a higher risk level, a different classification and registration process may apply.

2. Prepare Required Documentation

The application will require a set of documents, including:

• Application Form (MD-IVD-1): Fill out the MD-IVD-1 form, specifically for Class I IVD medical devices, available from the MDD website.
• Technical Documentation: This includes a complete description of the device, its intended use, and technical specifications. Provide detailed information on the device's design, manufacturing process, and its labeling and instructions for use.
• Declaration of Conformity: A formal statement by the manufacturer declaring that the device complies with relevant safety and performance standards.
• Quality Management System (QMS) Certification: Although not mandatory, if the manufacturer has ISO 13485 certification, include this as it can strengthen the application.
• Evidence of Safety and Performance: Documentation supporting the safety and effectiveness of the device, such as clinical data, risk analyses, and any regulatory approvals from other jurisdictions (like CE marking or FDA clearance).

3. Submit the Application to MDD

• Submit the completed application form and all required supporting documentation to the Medical Device Division of Hong Kong’s Department of Health. Fees for Class I devices may be minimal or not required; confirm this with the MDD before submission.

4. Review and Approval Process

• MDD will review the application to verify that the device meets the required standards. For low-risk Class I devices, this review process is often quicker than for higher-risk classifications.
• Once approved, the device will be listed in the MDACS database, which confirms that it meets safety and performance requirements for marketing within Hong Kong.

5. Post-Market Obligations

• After registration, manufacturers must maintain compliance with MDACS requirements, which includes monitoring device performance, reporting adverse events, and notifying the MDD of any significant changes to the device.

Benefits of MDACS Registration for Class I IVD Devices

• MDACS registration is voluntary but is advantageous because it assures healthcare providers and end-users of the device’s compliance with Hong Kong’s standards, which may improve market acceptance and trust.

By following these steps, manufacturers and distributors can successfully register Class I IVD medical devices under Hong Kong's MDACS program, facilitating market entry and enhancing credibility within the healthcare market.

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