MDIS — Medical Device Information System
HK-unique · MDACS listing portal and public database
MDIS serves two functions:
- Submission portal — LRPs submit listing applications, manage records, respond to MDD queries
- Public database — anyone can search for MDACS-listed devices and verify HKMD numbers
HKMD Numbers
Each listed device receives a unique HKMD number — the equivalent of an FDA 510(k) number or Australian ARTG number. This number:
- Appears in the public MDIS database
- Verifies listing status to hospitals and distributors
- Is tied to the LRP, not the manufacturer directly
Key MDIS Functions for LRPs
| Function | Detail |
|---|---|
| New listing application | Submit Class II/III/IV or IVD B/C/D applications |
| Application management | Track status, respond to queries, upload documents |
| Change notifications | Report significant device or LRP changes |
| Adverse event reports | Submit vigilance reports |
| FSCA notifications | Notify MDD of field safety actions |
Public Search
The public MDIS database can be searched by device name, HKMD number, manufacturer, LRP, or device class.
MDIS Registration Requirement
LRPs must register for MDIS access before submitting any application. MDIS registration is a prerequisite and is typically processed within 5–10 business days of application. Contact the MDD directly at [official MDD contact] to initiate registration and obtain login credentials.