Confirm that your device is classified as Class II IVD according to MDACS guidelines.

Confirm that your device qualifies as a Class II IVD according to MDACS guidelines.

Familiarize yourself with the Medical Device Ordinance (Cap. 663) and the specific guidelines for Class II IVDs provided by MDACS.

The time cycle for applying for Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) typically ranges from 3 to 6 months, depending on various factors such as the completeness of the application, complexity of the device, and responsiveness to any queries.

The process for registering Class II in vitro diagnostic (IVD) medical devices in Hong Kong under the Medical Device Administrative Control System (MDACS) involves several key steps.

Regular updates for Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) involve adherence to specific standards and processes to ensure ongoing compliance and safety.

After applying for Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS), several regulations and requirements must be followed to ensure ongoing compliance and successful market operation.

Before applying for Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS), it is essential to undertake thorough preparatory work.