Hong Kong Regulatory Approval Process for Medical and IVD Devices

Medical and in vitro diagnostic (IVD) devices in Hong Kong are regulated by the Medical Device Division (MDD). Currently, there is only a voluntary registration process under the Medical Device Administrative Control System (MDACS) available for medium- and high-risk devices. Low-risk devices are not eligible for registration with the MDD. Though the decision to register devices in Hong Kong is currently voluntary, both private and government hospitals may prefer devices with an MDD listing number, and device registration may become mandatory in the future. 

The Hong Kong MDD device approval process explained

The chart illustrates the MDD approval process per device classification in Hong Kong and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a simplified overview of the main steps for registration is provided here. 

Step 1
Determine the classification of your device according to the MDD’s classification rules.  

Step 2 
Appoint a Local Responsible Person (LRP) to manage your device registration and interact with the MDD on your behalf. 

Step 3 
Prepare the MDACS application along with the required documentation for submission to the MDD.  

Step 4 
Your LRP submits the application to the MDD. No fees are charged for device registration at this time. 

Step 5 
The MDD reviews the application and may request additional information.  

Step 6 
Upon approval, the MDD issues the listing number for your device.