Hong Kong Database Update: Electronic Adverse Event and Safety Report Features

By Amelia Boldrick and Elizabeth Pugh

Last month the Hong Kong Department of Health delayed release timelines for multiple new features of the Medical Device Information System (MDIS) to September 2024, including electronic submissions for adverse event and safety alert reports. Following a transition period, paper-based submissions are expected to be phased out by the end of the year.

Background on MDIS

The MDIS is a web-based application intended for industry submissions of online applications to list medical devices and traders under the Medical Device Administrative Control System (MDACS) and to report adverse events and safety alerts related to medical devices. Traders include importers, distributors and local manufacturers of medical devices.
 

Key dates of MDIS delayed

Key dates that have recently been updated are outlined in the table.

Concluding remarks

Manufacturers and representatives (local responsible persons (LRP)) based in Hong Kong need to create an account in MDIS and begin using the new system for submissions before the phase-out date of paper-based submissions. Additional information can be found on the Medical Device Division (MDD) website.

As an experienced LRP, Emergo by UL holds an MDIS account, offering medical device listing and vigilance reporting services in Hong Kong.