HSA Reference Agencies and the Independent Agency Counting Rule

1. Key takeaways

The Reference Agencies recognised by HSA include: Australia’s TGA, Health Canada, Japan (Shonin / Ninsho), the US FDA (510(k) / De Novo / PMA), EU Notified Bodies, and a Malaysian MDA registration obtained through a full conformity assessment. Three key rules govern how these approvals are counted: first, HSA counts TGA and EU Notified Bodies together as one independent agency; second, devices that the Reference Agency has classified as Class I or Class II exempt cannot use that approval to qualify; third, the approval must cover the same device and the same intended use.

• The independent-agency count is the single most common source of eligibility errors, and a miscount can end in the forfeiture of a granted registration.
• Holding an ARTG entry from TGA and a CE certificate at the same time still counts as only one independent agency under the HSA counting rule.
• Companies with only one recent approval can shorten the path by obtaining a second approval from a different independent agency, thereby avoiding the three-year market history requirement.
• The same device and the same intended use are hard constraints: any divergence between the Singapore proposed labeling and the Reference Agency approval undermines the reliance basis.
• A Malaysian MDA registration obtained through a full conformity assessment can support the Singapore Abridged route, which makes country sequencing a decision with real economic value.

2. Legal basis

The rules on Reference Agencies and route eligibility are set out in GN-15 sections 4 to 6. The table below summarises the recognised agencies, the regional reliance provision for Malaysia, the counting rule and the exclusions. Where specific clause wording has been compiled from industry consolidation rather than official text, the HSA official text prevails.

3. Expert insights

Insight one: the independent-agency count is the easiest number to get wrong, and the price of getting it wrong is a revoked registration.

We have seen clients hold both an ARTG entry from TGA and a CE certificate and conclude that they have two independent approvals and can therefore take the Immediate route. Under the HSA counting rule, TGA and EU Notified Bodies are counted as one independent agency, so this is only one. For a company with a single recent approval, the correct way to accelerate is to obtain an additional approval from a different independent agency, such as the US FDA or Health Canada, which removes the wait for the three-year market history.

Insight two: the same device plus the same intended use is a hard constraint.

The logic of the Abridged and Expedited routes is that HSA relies on the evaluation the Reference Agency has already performed. That reliance is only valid when the product submitted in Singapore is the same device that was approved abroad and is offered for the same intended use. If the intended use on the Singapore proposed labeling differs from the use approved by the Reference Agency, the reliance basis no longer holds. Annex 4 Part 1, newly added in GN-15 R14, requires applicants to proactively disclose exactly this kind of labeling difference, and that disclosure obligation is itself an important signal: HSA is comparing labels in earnest. Differences that surface only at query stage cost far more time than differences disclosed upfront.

Insight three: a low-risk classification by the Reference Agency closes the door.

If the Reference Agency has listed the device as Class I (for example, US FDA Class I) or Class II exempt, HSA will not accept that approval as the basis for the Abridged or Expedited routes. The reason is not hard to see: such approvals involve no substantive review, so there is no evaluation conclusion to rely on.

Insight four: the Malaysian MDA registration is the most underestimated asset in the region.

Chinese manufacturers in Southeast Asia commonly register in Malaysia first, under the Act 737 system, and obtain a registration that has gone through a full conformity assessment by MDA-recognised assessors. Under GN-15 R13, that registration can in turn support the Singapore Abridged route. When planning Southeast Asia as a whole, the order of countries is a decision variable with economic value. Treating Malaysia as the first filing rather than an afterthought can shorten the Singapore timeline materially, because the qualifying evidence is already in hand when the Singapore dossier is assembled.

4. Practical recommendations

• Maintain an approval ledger: record for every approval the issuing agency, the approval type, the approval date, the original wording of the intended use, and the risk classification assigned by the Reference Agency.
• Recount the independent agencies under the HSA rule: never count TGA and an EU Notified Body as two.
• Compare intended uses word for word: compare the proposed Singapore use against the approved use of the Reference Agency line by line, and prepare explanations for any differences in advance.
• Plan the second approval: if the target is the Immediate route and only one recent approval is held, weigh the cost of obtaining a second independent-agency approval against the Class B Full route at 3,900 SGD over 160 working days.

5. Verification checklist

• □ All existing overseas approvals and their agencies have been listed
• □ The number of independent agencies has been counted under the HSA rule (TGA + EU NB = 1)
• □ The Reference Agency risk classification of the device has been confirmed (Class I / Class II exempt excluded)
• □ Intended uses have been compared word for word
• □ A labeling difference statement has been prepared (Annex 4 Part 1)
• □ Documentary evidence of each approval is on file

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Singapore. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with HSA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com