Once your Class B medical device is registered (listed) with MDACS, the registration is valid indefinitely unless you voluntarily cancel it or your device status changes.

The purpose of obtaining Class B medical device MDACS registration in Hong Kong is to ensure that your medical device, classified as Class B (low-to-moderate risk), is legally authorized to be marketed, imported, and sold in Hong Kong under the regulatory framework managed by the Department of Health.

The duration of Class B medical device MDACS registration in Hong Kong typically takes around 8 to 14 weeks (about 2 to 3.5 months) from the date of application submission to final approval.

Class B medical device MDACS registration in Hong Kong means the process of officially registering a medical device classified as Class B under Hong Kong’s Medical Device Administrative Control System (MDACS) to legally market and distribute it in Hong Kong.

Step 1: Confirm Device ClassificationMake sure your device is classified as Class B under the MDACS framework.

Application Procedures for Class B Medical Device MDACS Registration

How to Process Class B Medical Device MDACS Registration

MDD checks for completeness of the application.