When registering a Class II in vitro diagnostic (IVD) medical device in Hong Kong under the Medical Device Administrative Control System (MDACS), several standards and guidelines must be adhered to ensure compliance with regulatory requirements.

When registering a Class II in vitro diagnostic (IVD) medical device in Hong Kong under the Medical Device Administrative Control System (MDACS), you must prepare and submit several technical documents to demonstrate the device’s safety, efficacy, and compliance with regulatory standards.

The processing cycle for Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS) generally involves several phases, from application submission to approval.

To apply for Class II in vitro diagnostic (IVD) medical device registration in Hong Kong under the Medical Device Administrative Control System (MDACS), several conditions must be met.

Device Description: Detailed information about the IVD, including its intended use and indications for use.

When registering a Class II in vitro diagnostic (IVD) medical device in Hong Kong under the Medical Device Administrative Control System (MDACS), specific materials and documents are required to ensure compliance with regulatory standards.

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

The primary platform for registration is the MDACS official website. Here, you will find all necessary information, guidelines, and resources related to the registration process.