Singapore vs TGA / FDA / CE / Health Canada
High-level comparison
| Feature | Singapore (HSA) | Australia (TGA) | US (FDA) | EU (CE/MDR) | Canada (HC) |
|---|---|---|---|---|---|
| Primary legislation | Health Products Act (Cap. 122D) | Therapeutic Goods Act 1989 | FD&C Act + 21 CFR | MDR 2017/745 / IVDR 2017/746 | Medical Devices Regulations (SOR/98-282) |
| Regulator | HSA | TGA | FDA CDRH | EU Notified Bodies + NCAs | Health Canada |
| Classification | A / B / C / D | I / IIa / IIb / III / AIMD (IVD: 1/2/3/4) | I / II / III (exempt/510k/PMA) | I / IIa / IIb / III (IVD: A/B/C/D) | I / II / III / IV |
| Pre-market pathway | Registration via SHARE | ARTG inclusion | 510(k) / De Novo / PMA | CE marking via NB + DoC | Device licence |
| Overseas recognition | Formally recognises TGA, EU NB, HC, MHLW, FDA | Recognises EU, FDA, others for comparable overseas regulator pathway | Does not formally recognise other agencies | Does not recognise non-EU approvals | References TGA, FDA, EU |
| Lowest-risk devices | Class A — exempt from registration, notification required | Class I — ARTG inclusion without clinical evidence | Class I exempt — no 510(k) needed | Class I self-declaration — no NB required | Class I — no licence needed |
| IVDs | Integrated into same Class A/B/C/D system | Separate IVD classification | FDA IVDMIA and separate clearance pathway | IVDR 2017/746 (separate regulation) | Integrated |
| Unique dual obligation | Product registration AND dealer's licence both required | Single ARTG entry (sponsor concept) | No separate dealer licence | No separate dealer licence | No separate dealer licence |
Key differences to watch for
Dual obligation: Singapore's separate dealer's licence requirement has no direct parallel in TGA, FDA, CE, or Health Canada frameworks. Overseas manufacturers and their Singapore partners must ensure both obligations are met.
Class A notification: Singapore's Class A notification (required even though registration is exempt) also has no direct parallel — TGA Class I devices are included on the ARTG; FDA Class I exempt devices require no submission; EU Class I self-declaration requires no NB involvement.
Evaluation routes and reference agencies: Singapore's formal reliance on specific overseas approvals for Abridged/Expedited/Immediate routes is a distinctive feature. TGA's comparable overseas regulator pathway and Health Canada's approach to international data are similar in concept but differ in detail.
IVD treatment: Singapore integrates IVDs into the same A/B/C/D classification as general devices (with a separate set of classification rules). The EU uses entirely separate legislation (IVDR). The US FDA has distinct IVD pathways (510(k) for many IVDs, PMA for high-risk).