Documentation Preparation: Time taken to gather and prepare the required documents, including the technical file, clinical data, quality management system evidence, labeling, and risk management documentation. This can take several weeks to months, depending on the complexity of the device and readiness of documentation.

Ensure that the device is correctly classified as a Class III IVD. This classification is based on its intended use, risk level, and potential impact on health.

Before applying, familiarize yourself with the MDACS guidelines and requirements specific to Class III IVDs. Ensure that your device meets the classification criteria.

Obtain and fill out the MDACS application form accurately, providing all required information.

Confirm that your device qualifies as a Class III IVD based on intended use and risk assessment.

To apply for MDACS registration of Class III in vitro diagnostic medical devices in Hong Kong, you should submit your application to the Medical Device Control Office (MDCO) under the Department of Health.

Application Fees: Typically, the fees range from a few thousand to tens of thousands of HKD, depending on the specific device and its classification.

Device Classification: Confirmation that the device is classified as Class III based on intended use and risk assessment.