Labeling under Article 26: ISP Numbering and Spanish-Language Requirements

1. Key takeaways

Article 26 of DS 825/1998 provides: controlled products must be clearly marked on the product itself or its packaging as having passed conformity verification, together with the number assigned by the ISP; where marking is genuinely impossible due to the nature, composition or volume of the product, an exemption or another form of marking must be granted by ISP resolution. In parallel, the label (rótulo) and instructions for use (IFU) submitted for registration must be in Spanish — this is the language requirement for ISP acceptance.

GRZAN groups labeling risks into three types: a missing ISP number, a literal translation from English, and a holder name or address that no longer matches the registration. The third type surfaces most often after a distribution channel changes, and it is the one with the sharpest commercial consequences. All three share a root cause: labeling treated as a packaging task rather than a regulatory deliverable with its own owner.

2. Legal basis

• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 26: controlled products must be clearly marked on the product or its packaging as having passed conformity verification, with the number assigned by the ISP; where marking is impossible due to the nature, composition or volume of the product, an exemption or another form of marking requires an ISP resolution.
• Same instrument | Article 2, item 14 | the intended use is that indicated by the manufacturer on the label, in the instructions for use and/or in promotional material.
• Same instrument | Article 21(a), point 1 | identification information includes packaging labels, package inserts, batch numbers and coding.
• ISP procedure | prestación 9100003 (v3, September 25, 2025) | the Spanish-language draft label (rótulo) and draft instructions for use (IFU) must be submitted.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | Article 30 | selling or distributing products without a conformity verification certificate leads to seizure of the goods.

3. Expert insights

Insight one: the number marking of Article 26 is an obligation after registration, not a dossier item.

The provision requires the number assigned by the ISP, which only comes into existence at approval. The correct sequence is: submit the draft label without the number, obtain the number on approval, then update the label and start production. Printing the number on the label used for the first submission is an impossible task, yet companies routinely sequence it wrong and either delay filing or misstate the artwork timeline to their suppliers. The artwork workflow should therefore carry a placeholder field for the ISP number from the first draft, so approval changes only that field.

Insight two: the exemption is granted by ISP resolution, not by the company’s own judgment.

For products too small to mark — some implants and catheters, for example — the provision’s route is exemption or another form of marking by ISP resolution. This is something to apply for; it cannot be assumed that a product is simply too small to be marked. An unrequested omission is treated as a violation of Article 26 even when the underlying engineering reason would have justified an exemption had one been sought. Applications for exemption should describe the physical constraint and propose the alternative marking, such as unit-dose packaging or a statement in the instructions for use.

Insight three: the Spanish requirement is a dual requirement of language and content.

The language must be Spanish, and the content must match the intended use declared in the dossier. The most frequent error GRZAN encounters is literal translation from an English label — it produces inappropriate terminology and stiff phrasing, and it drifts from the intended use wording on file. Translation for labels is a regulatory writing task with terminological constraints, not a marketing localization task, and it should be staffed and reviewed accordingly. A terminology list agreed with the translator, derived from the Spanish dossier wording, keeps the label and IFU aligned with the registered intended use.

Insight four: the label is the first scene of any inspection.

When SEREMI inspects the market and warehouses, the label is the easiest item to verify. A holder or manufacturer name and address that does not match the registration directly triggers inspection queries, and in serious cases goods are seized under Article 30. Failing to update labels after a channel change is the classic source of this mismatch, because commercial teams sign the new distribution agreement months before anyone tells the regulatory team to redraw the artwork. A quarterly check that the label master data matches the current registration closes the gap between commercial changes and released artwork.

4. Practical recommendations

1. Sequence production as draft first, number afterwards: submit the Spanish label and IFU drafts, obtain the ISP number on approval, then update the artwork for production.
2. Apply early for the Article 26 exemption for volume-limited products; do not omit the marking on your own authority.
3. Have the Spanish localization done by translators with a medical device background, avoiding literal translation from English.
4. Build label master data: product name, model, manufacturer, holder name and address, intended use, batch number, shelf life and storage conditions — all fields drawn from the master data.
5. Update labels in step with any change of channel or holder, keeping version records of every released artwork.

5. Verification checklist

• □ A marking scheme containing the ISP number has been designed under Article 26
• □ Volume-limited products have an exemption application filed with the ISP
• □ The Spanish label and IFU drafts have been submitted and approved
• □ Label and IFU master data exist and have been checked field by field
• □ The holder name and address match the registration certificate

Regulatory information verified as of October 29, 2026.

For a product-specific feasibility assessment of Chile market entry, GRZAN’s regulatory team supports manufacturers and importers with registration dossiers, conformity documentation and ISP submissions. Contact info@grzanglobal.com to discuss your project.