To apply for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong, certain conditions and requirements must be met. These conditions ensure that the device is safe, effective, and compliant with local regulations.

Confirm that your IVD device is classified as Class IV, which is typically for high-risk devices. Ensure you understand the specific regulatory requirements for this classification.

To apply for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong, specific materials and documentation are required. Here's a detailed list of the necessary materials and guidance on how to prepare the application documents effectively.

The process for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong involves several steps and requires specific materials. Here’s a detailed overview of the registration process, the materials needed, and key considerations to keep in mind.

To apply for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong, you need to submit your application to the Medical Device Control Office (MDCO), which operates under the Department of Health.

The specific application fees for MDACS registration can vary depending on the type of device and the complexity of the application. As of the latest information, the fee structure for Class IV devices is generally higher than for lower-risk classifications.

To apply for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong, you must adhere to a comprehensive set of requirements. These requirements ensure the devices' safety, effectiveness, and quality.

Application Form: Complete the designated MDACS application form for Class IV IVD devices.