MDACS Listing Overview
HK-unique listing system
MDACS listing adds a device to Hong Kong's MDIS database and issues an HKMD listing number. Only the LRP may submit a listing application.
Eligible Device Classes
| Class | Eligible? |
|---|---|
| General Class I | ❌ No |
| General Class II, III, IV | ✅ Yes |
| IVD Class A | ❌ No |
| IVD Class B, C, D | ✅ Yes |
Two Listing Routes
| Route | Description | Best For |
|---|---|---|
| Standard | Full documentation review by MDD | Devices without reference-country approvals |
| Expedited (Reliance) | Relies on prior reference-country approval | Devices with FDA, CE, TGA, Health Canada, MHRA, or PMDA approvals |
No Application Fee
The MDD does not charge a government application fee — no fee tiers, no annual charges. Budget for LRP service costs and ISO 13485 certification, but not MDD fees.
Post-Listing
Upon approval:
- HKMD number assigned and published in MDIS
- LRP assumes ongoing post-market obligations
- Listing valid indefinitely unless significant changes occur or listing is withdrawn