Indonesian Labelling and IFU Requirements: Mandatory Bahasa Indonesia and E-Labeling

1. Key takeaways

Indonesian is mandatory for device labelling, and the requirement is stricter than most manufacturers assume. Device labels, outer packaging labels and instructions for use (IFU) must be in Indonesian. A foreign language is permitted only where no corresponding Indonesian expression exists. This is the most rigid rule in Indonesian market access and the one most consistently underestimated by Chinese manufacturers — not because it is obscure, but because it looks like a translation task rather than a regulatory one, and it is neither.

The label itself carries a defined minimum content set, and the newest regulation has broadened what a label can be. Labelling can now exist in electronic form, which opens a compliance path for e-labelling and QR-code approaches that did not previously have an explicit regulatory footing.

• Mandatory content: product name, model, manufacturer name and address, registration number (NIE), batch or serial number, production date and expiry, storage and handling conditions, warnings and cautions; packaging also carries graphics and warning symbols or marks.
• New definition under Permenkes 11/2025: labelling is information presented objectively, completely and non-misleadingly in images, colours, text or a combination, in physical or electronic form, attached to or placed inside the packaging, or provided as a link forming part of the container and/or packaging.
• E-labelling: the link-based definition opens space for e-labeling and QR codes; professional-use devices may consider carrying the IFU via link.
• Five rejection points: no Indonesian version, visible machine translation, inconsistency with the LoA and CFS, missing registration or batch number fields, and missing or overly brief warnings.
• Language division: regulator-facing technical documents may be in English; user documents must be in Indonesian.

2. Legal basis

The labelling definition and its electronic and link-based forms come from Permenkes No. 11/2025. Operationally, Kemenkes issues current technical guidance on labels and IFU, and the Indonesian-language requirement is enforced through established practice. Where sworn translation applies, the work must be performed by sworn translators — the Hague Convention’s list of public documents expressly includes sworn translations, confirming that such documents hold formal status in Indonesia. The references below were verified on 26 October 2026.

The definition is the significant change. By defining labelling as information presented objectively, completely and non-misleadingly in images, colours, text or their combination, in physical or electronic form, attached to the packaging, placed inside it, or provided as a link that forms part of the container and/or packaging, Permenkes 11/2025 gives e-labeling and QR codes an explicit regulatory footing. Professional-use devices are the natural first candidates for carrying the IFU by link, since their users are equipped and accustomed to digital references.

3. Expert insights

Insight 1: the five rejection points are a preview of the reviewer’s checklist. They are: ① no Indonesian version — the most common failure; ② visible machine translation — wrong terminology and broken sentence structure prompt the reviewer to question the whole file’s reliability; ③ product name or model on the label inconsistent with the LoA and CFS — a cross-document consistency failure that surfaces only when the administrative set is read together; ④ missing registration number or batch number fields; and ⑤ warnings and cautions that are missing or too brief. Each is detectable before submission, and each is cheap to fix on paper and expensive to fix after a deficiency notice.

Insight 2: the language rule splits the document set in two. Regulator-facing technical documentation may be submitted in English. User documents must be in Indonesian. The split means translation is a workstream with its own schedule, budget and quality gate — not an appendage of dossier writing. Teams that leave it to the end discover that Indonesian labelling work has dependencies of its own: terminology decisions, licence holder review and consistency checks against the risk management file.

Insight 3: machine translation fails a regulatory test, not a stylistic one. The problem with obvious machine translation is not aesthetics. Terminology errors and ungrammatical sentences signal to the reviewer that the file was assembled without local expertise, which invites deeper scrutiny of everything else in the submission. Terminology inconsistency across the document set is itself a rejection reason, so translation quality is a compliance variable with direct approval consequences.

4. Practical recommendations

• Have the licence holder review Indonesian labels and IFU locally. Do not deliver machine translation output as a final draft.
• Lock technical terms in English first, then translate once. Have the Indonesian licence holder translate the locked terms uniformly across the full document set.
• Check terminology consistency across every document. Inconsistent terms across the set are themselves a rejection reason.
• Audit label content against the mandatory fields: product name, model, manufacturer, NIE, batch or serial number, production date and expiry, storage and handling conditions, warnings and cautions.
• Cross-check the label against the LoA and CFS so product names and models agree across all three documents.
• Consider link-based IFU for professional-use devices under the Permenkes 11/2025 e-labelling definition, with the QR or link designed as part of the packaging.
• Engage sworn translators where sworn translation applies, consistent with the Hague Convention’s recognition of sworn translations as public documents.

The common thread is that labelling is a system, not a print job. The label, the IFU, the packaging, the LoA and the CFS must tell one story in one terminology, in Indonesian where users will read it and in English where reviewers will. Assembling that system early — with the licence holder as the terminology authority — is what turns the most rigid rule in Indonesian market access into a routine workstream.

5. Verification checklist

• □ Labels, outer packaging labels and IFU all provided in Indonesian
• □ Foreign-language text used only where no Indonesian expression exists
• □ All mandatory fields present: product name, model, manufacturer, NIE, batch or serial number, production date and expiry, storage and handling, warnings and cautions
• □ Product name and model on the label consistent with the LoA and CFS
• □ Indonesian text reviewed locally by the licence holder; no machine-translation drafts delivered
• □ Terminology uniform across the full document set
• □ E-labelling or link-based IFU assessed against Permenkes No. 11/2025 where applicable
• □ Sworn translation performed by sworn translators where required

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