FDA vs TGA · CE · Health Canada · HSA
Understanding how the US FDA framework compares to other major jurisdictions is essential for manufacturers pursuing multi-market strategies.
Framework comparison overview
| Feature | 🇺🇸 USA (FDA) | 🇦🇺 Australia (TGA) | 🇪🇺 EU (CE/MDR) | 🇨🇦 Canada (HC) | 🇸🇬 Singapore (HSA) |
|---|---|---|---|---|---|
| Regulator | FDA / CDRH | TGA | Notified body + competent authority | Health Canada | HSA |
| Primary legislation | FD&C Act | Therapeutic Goods Act 1989 | EU MDR 2017/745 | Medical Devices Regulations | Health Products Act |
| Classification | Class I / II / III | Class I / IIa / IIb / III / AIMD | Class I / IIa / IIb / III / AIMD | Class I / II / III / IV | Class A / B / C / D |
| Submission type | 510(k) / De Novo / PMA | ARTG inclusion (via TGA pathway) | CE marking (via Notified Body) | Device Licence | Product registration |
| Conformity assessment | FDA directly reviews | TGA + comparable overseas regulator | Notified body | TC-6 test reports | HSA + recognised conformity |
| QMS standard | 21 CFR Part 820 (QMSR) / ISO 13485 | Essential Principles + ISO 13485 | ISO 13485 (mandatory) | ISO 13485 | ISO 13485 |
| UDI | 21 CFR Part 830 (GUDID) | TGA UDI (aligned with IMDRF) | EUDAMED UDI | Health Canada UDI | HSA UDI (IMDRF-aligned) |
| Adverse event reporting | MDR (21 CFR 803) | IRIS system | EUDAMED PSUR / PMCF | Problem report | HSA reporting |
| Post-market surveillance | 522 studies, PMS plan | PMS by class | MDR PMS plan (mandatory) | PMS plan | PMS plan |
510(k) vs other "predicate-based" pathways
| Jurisdiction | Equivalent concept |
|---|---|
| USA — 510(k) | Substantial equivalence to a US predicate |
| Australia — Comparable Overseas Regulator | Reliance on TGA, FDA, CE, or HC decision |
| Singapore — Abridged Route | Reliance on FDA, CE, TGA, or HC approval |
| Canada — Class II device licence | Declaratory submission with limited data for low-risk Class II |
| EU — MDR | No "predicate" concept — conformity to GSPRs and clinical evaluation required for all classes |
Clinical evidence comparison
| Jurisdiction | Clinical evidence required for mid-risk devices? |
|---|---|
| USA (510(k)) | Not always — bench testing often sufficient for Class II |
| EU (MDR) | Yes — clinical evaluation mandatory for all classes |
| Australia (TGA) | Depends on class and pathway |
| Canada | Required for Class III/IV; Class II often documentation-based |
| Singapore | Depends on route (abridged vs full) |
Using FDA clearance in other markets
FDA 510(k) clearance or PMA approval is accepted as a reference for submissions in:
- Australia — comparable overseas regulator pathway (FDA is a listed comparable regulator)
- Singapore — abridged route accepts FDA clearance
- Canada — reference device concept for Class II devices
- EU — FDA approval is not accepted for CE marking; full MDR conformity required