Overseas Reference Regulatory Agencies
Why reference agencies matter
Singapore's abridged, expedited, and immediate evaluation routes all depend on the applicant holding current approvals from one or more of HSA's recognised overseas reference regulatory agencies. These agencies are considered to have sufficiently rigorous review processes that their approvals can be relied upon to reduce the scope of HSA's own evaluation.
The five recognised agencies are:
| Agency | Country | Recognised approval types |
|---|---|---|
| TGA — Therapeutic Goods Administration | Australia | Device Registration Licence (ARTG inclusion) |
| EU NB — European Union Notified Bodies | EU/EEA | EC certificates (specific types — see Evaluation Routes) |
| HC — Health Canada | Canada | Medical Device Licence |
| MHLW — Ministry of Health, Labour and Welfare | Japan | Ninsho (certification by registered certification body) or Shonin (ministry approval) |
| US FDA — Food and Drug Administration | USA | 510(k) clearance, De Novo, or PMA |
The same labelled use requirement
A critical condition that is easy to overlook: the overseas approval relied upon must be for the same medical device with the same labelled intended use that is being registered in Singapore.
This means:
- A device approved in the US under a broader intended use cannot be used to support a Singapore registration for a narrower use (or vice versa) unless the labelled uses are substantively the same.
- Approvals for similar devices from the same manufacturer do not count — it must be the same device.
- A PMA supplement or 510(k) for a variation of an original device may qualify for a variation application in Singapore but may not fully qualify a fresh Singapore registration.
Class I and II exempt devices — the exclusion
Class I (US FDA) and Class I/II exempt approvals do not qualify for any of HSA's abridged, expedited, or immediate routes. The overseas approval must correspond to a device that underwent substantive regulatory review by the reference agency — not a simple registration or exemption.
Specifically:
- US FDA 510(k) clearances for devices classified as Class I exempt or Class II exempt do not qualify.
- EU Class I self-declaration (no Notified Body involved) does not qualify.
- TGA inclusions based solely on manufacturer's evidence for Class I devices do not qualify for abridged.
Verifying overseas approvals
When preparing an application, ensure you can provide evidence of the relevant overseas approval, including:
- The approval/clearance/licence number and date of issue;
- The device name and intended use as it appears on the overseas approval;
- Evidence that the approval remains current (not cancelled, suspended, or withdrawn);
- For EU NB certificates: the certificate type, issuing NB, and the directive/regulation it was issued under.
HSA may contact the reference agency to verify the approval during its review.
Safe marketing history
For expedited (ECR-1) and immediate (IBR Condition 1) routes, a device must have been marketed in the reference agency's jurisdiction for at least three years without known safety issues. This is assessed based on:
- The date of the original overseas approval;
- Absence of any safety-related recalls, field safety notices, or regulatory actions against the device in any market;
- No prior rejection or withdrawal by HSA or any reference agency.
Strategic implications for market entry
Understanding the reference agency framework is central to Singapore market entry strategy. Common approaches:
- CE + TGA first: EU Notified Body certification and Australian TGA ARTG inclusion together typically unlock the ECR or IBR route for Singapore, significantly reducing time to market.
- FDA 510(k) + TGA: a strong combination for Class C devices aiming for ECR-1 or ECR-2.
- FDA PMA: for Class D, PMA (plus one other reference agency) can satisfy EDR conditions, noting EDR exclusions.
- Japan-first for Class D implants: MHLW Shonin for active implantables, combined with another reference agency, may satisfy EDR where the device is not on the EDR exclusion list.
See Singapore vs TGA / FDA / CE / Health Canada for a fuller comparison.