Expedited Listing — Reliance Scheme
HK-unique · Fastest route to MDACS listing
The expedited reliance scheme allows the MDD to rely on a prior approval from a trusted reference authority, reducing documentation burden and review time.
Accepted Reference Authorities
| Authority | Jurisdiction | Approval Types |
|---|---|---|
| FDA (CDRH/CBER) | United States | 510(k), PMA, De Novo |
| European Commission (via NB) | EU | CE marking (MDR/IVDR) |
| TGA | Australia | ARTG entry |
| Health Canada | Canada | Medical Device Licence |
| MHRA | United Kingdom | UKCA / legacy CE |
| PMDA | Japan | Shonin approval |
Eligibility
- Device has a current, valid approval from an accepted reference authority
- Device submitted to MDD is identical to the reference-approved device
- Same intended purpose, materials, and design specifications
Required Documentation (Expedited)
- Reference-country approval evidence (approval letter/certificate)
- Device description confirming identity with reference submission
- Essential principles compliance statement
- Current HK labelling
- ISO 13485 certificate
- LRP appointment documentation
Preferred route if reference approval exists
If you hold FDA clearance, CE marking, or TGA registration, always use the expedited scheme — it will materially shorten your MDACS listing timeline and reduce documentation burden.