HSA Labelling Requirements for Medical Devices under GN-23 R2

1. Key takeaways

Labels and instructions for use for medical devices supplied in Singapore must be in English, with no translation requirement, no notarisation and no apostille chain. The labelling rules are set by GN-23 R2, Guidance on Labelling for Medical Devices, issued in September 2022, and are harmonised with the ASEAN Medical Device Directive. In registration review HSA examines sample labels together with packaging, instructions for use, training materials, manuals and installation instructions, so the compliance boundary extends well beyond the printed label itself.

• English is the required language. Additional Chinese, Malay or Tamil text may be added, provided it does not contradict the English content.
• GN-23 R2 of September 2022 is the governing guidance and is aligned with the ASEAN Medical Device Directive.
• The review set covers labels, packaging, instructions for use, training materials, manuals and installation instructions.
• Instructions for use are generally required in English and must be sufficient for safe and effective use, covering set-up, operation, maintenance and troubleshooting; some low-risk categories are exempt.
• Where the Abridged, Expedited or Immediate route is used, Annex 4 Part 1 requires differences against the reference agency label to be disclosed.

2. Legal basis

GN-23 R2 sets out what a Singapore label and instruction set must contain and in what language. It applies within the ASEAN CSDT submission format defined by GN-17 R5 and GN-18 R5 of October 2026, where labelling and instructions for use form their own module. The language rule is the simplest part of the document and the part with the largest practical effect: English is the operative language, and the addition of other languages is permitted only on condition that the additional text does not conflict with the English content. The guidance is harmonised with the ASEAN Medical Device Directive, which is why a label built for the region usually needs only local adjustment rather than redesign.

The rule that other languages may be added is frequently misread as a rule that they must be identical in extent. The actual condition is narrower and more practical: the additional language must not contradict the English text. That places the burden on consistency of meaning rather than on literal correspondence, and it makes the comparison of intended use, warnings and contraindications across languages the specific point of risk. Regulatory information in this article was verified to 26 October 2026 against secondary sources, namely GN-23 R2, GN-17 R5, GN-18 R5 and Annex 4 to GN-15 R15.

3. Expert insights

English-only labelling makes Singapore the lightest labelling workflow in the region. The comparison is clearest when the neighbours are placed alongside. Indonesia requires Bahasa Indonesia, Thailand requires Thai and Vietnam requires Vietnamese, and in each case the requirement usually brings localised redesign rather than translation alone. Singapore requires English. A manufacturer that already holds US or European English labelling normally needs only local adjustment, covering the Registrant or dealer contact details and the registration number, instead of a new label design.

Adding other languages is a commercial choice, not a compliance obligation. Singapore permits parallel languages, subject to the non-contradiction condition. When we review a multilingual label, the check is whether intended use, warnings and contraindications say exactly the same thing in each language. Every additional language is an additional place for an error to sit undetected, and the errors that matter are not typographical; they are the ones where a warning becomes softer or a contraindication becomes narrower in translation.

HSA reviews training materials and installation instructions, not only the label. This point is regularly missed. The HSA review set includes training materials, manuals and installation instructions, and those documents are subject to the same advertising and labelling rules as the label itself. We have seen technical manuals containing promotional language that overstated performance, with a resulting request to correct the material. The lesson is that the compliance review has to cover every document that travels with the product, because a claim does not become acceptable by being printed in a service manual.

Label difference disclosure is a new obligation introduced in 2026. Part 1 of Annex 4, introduced through GN-15 R14, requires applicants filing through the Abridged, Expedited or Immediate route to disclose the differences between the Singapore label and the label approved by the reference agency. The practical consequence is that the reference agency label cannot simply be reused. A comparison has to be performed first, documented, and used as an input to the route decision. Where the differences are material, the route itself may be in question.

Advertising rules and labelling rules are separate regimes that intersect. Label content is governed by GN-23, while promotional content is governed by GN-08 on advertising and promotion. The same claim, placed on a label and placed in a brochure, is assessed under different rules and against different tests. Teams that maintain a single approved claims list and apply it everywhere tend to discover the difference at the wrong moment, which is why the two sets of rules are best reviewed together before any material goes to print.

4. Practical recommendations

• Build the English label as a regional template with replaceable fields for Registrant details, registration number and local dealer information, so that market variants stay small.
• Where languages run in parallel, compare sentence by sentence for consistency, with particular attention to warnings and contraindications.
• Bring training materials, manuals and installation instructions into the compliance review, since they fall within the HSA review set.
• Complete the label comparison against the reference agency label before selecting the Abridged, Expedited or Immediate route, because Annex 4 Part 1 makes it mandatory.
• Do not commission translation certification for Singapore, as it adds cost without affecting acceptability.

5. Verification checklist

• □ Labels and instructions for use are in English.
• □ Any parallel-language content is consistent with the English text.
• □ Instructions for use cover set-up, operation, maintenance and troubleshooting.
• □ Confirmed whether a low-risk exemption from the instruction requirement applies.
• □ Training materials, manuals and installation instructions included in the review.
• □ Label comparison against the reference agency approval completed, as required by Annex 4 Part 1.

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