HK vs Other Jurisdictions
MDACS · Multi-market comparison
Overview
Hong Kong's MDACS is an administratively-operated voluntary listing system — distinct from the statutory registration regimes of most comparable markets. This table compares key features:
| Feature | HK (MDACS) | SG (HSA) | AU (TGA) | EU (MDR) | CA (Health Canada) |
|---|---|---|---|---|---|
| Legal basis | Administrative (no standalone MD Act yet) | Medical Devices Act | Therapeutic Goods Act | EU Regulation 2017/745 | Medical Devices Regulations |
| Classification | Class I–IV / IVD A–D (IMDRF) | Class A–D (ASEAN AMDD) | Class I–AIMD (GMDN-based) | Class I–III (MDD-derived) | Class I–IV |
| Local entity required | Yes — LRP | Yes — local company via SHARE | No (but regulatory sponsor needed) | Yes — EU-based PRRC/AR | Yes — Canadian Importer |
| Fee on application | No MDD fee | Yes | Yes | Via Notified Body | Yes |
| Reliance pathway | Yes — expedited scheme (US · EU · AU · CA · UK · JP) | Yes — via ASEAN & reference NRAs | Yes — Global Market Access pathway | Not formally — MR mutual recognition for some | Yes — MDSAP recognition |
| UDI requirement | Under development | Yes — GUDID-aligned | Yes | Yes — EUDAMED | Yes |
| CSDT / STED format | IMDRF-aligned dossier | ASEAN CSDT | STED (IMDRF) | EU Technical Documentation | STED (Health Canada) |
Multi-Market Strategy Notes
For devices already CE-marked or FDA-cleared:
- HK's expedited reliance scheme accepts both → use the expedited route
- SG's ASEAN CSDT aligns with IMDRF format used by HK → dossier reuse is straightforward
- Consider submitting to HK and SG simultaneously to maximise efficiency
For devices entering Asian markets:
- HK is often used as a reference market for Greater China and Southeast Asia
- An HKMD listing number improves credibility across the region
- The absence of an MDD application fee makes HK one of the most cost-efficient registration markets
IMDRF Membership and Alignment
The Hong Kong Medical Device Division (MDD) participates in IMDRF (International Medical Device Regulators Forum) activities:
- Adopted IMDRF classification rules (TR-003 and TR-004) aligned with IMDRF GHTF study group guidance
- Uses IMDRF essential principles (TR-001) equivalent to GHTF SG1/N78
- Vigilance framework follows IMDRF adverse event terminology
- UDI implementation guided by IMDRF UDI guidance
IMDRF alignment means Hong Kong's technical documentation standards are broadly compatible with US (FDA), EU, Australia, and Canada — supporting the expedited reliance scheme.