Completeness of the Application: If all required documents are submitted in the correct format and are complete, the processing time will be faster. Any missing or incorrect information may cause delays.

To apply for Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you must meet specific requirements set by the Medical Device Division (MDD) of the Department of Health. These requirements cover both the documentation and process necessary for a successful application.

To apply for Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you will need to prepare specific documents and submit them to the Medical Device Division (MDD) of the Department of Health. Here’s a step-by-step guide on the application process and where to submit it.

This is the primary form for Class I IVD device registration, available on the MDACS section of the Department of Health’s website. It requires details about the device, manufacturer, and intended use.

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.

To register and apply for Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you need to submit the application and required documentation to the Medical Device Division (MDD) of the Department of Health in Hong Kong.

The cost and time required for Class I IVD medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS) can vary based on the specifics of the device and the completeness of the application.

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.