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, performance data, or limited clinical data may be depending on the predicate device and device type 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
Official resources
- RAPath AU — Australia TGA
- RAPath EU — EU MDR/IVDR
- RAPath HC — Health Canada
- RAPath SG — Singapore HSA
- IMDRF
510(k) predicate devices must have valid FDA 510(k) or PMA clearance in the US market. FDA does not accept predicates that are cleared or approved solely in other countries. The predicate device's regulatory pathway in the US (510(k), PMA, or De Novo) does not need to match the applicant's intended pathway, provided the comparison supports substantial equivalence.