Ecuador Medical Device Labelling and IFU Requirements: Articles 48 to 52 of the ARCSA 2026 Regulation

1. Key takeaways

The labelling and instructions-for-use rules of Ecuador are concentrated in Articles 48 to 52. Labels must be written in Spanish or English, with characters that are clear, legible and indelible, and both the primary and the secondary container must carry 13 minimum items of information. The instructions for use must be written in Spanish — other languages may be added — and must be submitted for evaluation and approval as part of the registration file. Containers must not react physically or chemically with the product.

The practical estimate used by GRZAN is that labelling corrections are among the cheapest corrections to avoid and among the most common ones actually received, because teams design the carton label carefully but forget that the regulation demands the same 13 items on the primary container as well. A structured gap review of every packaging level against Article 49 before submission removes that entire class of findings.

2. Legal basis

The 13 minimum items of Article 49 are: the trade name; the contents of the container or package; the indications for use, where applicable; precautions and warnings for use, which may be expressed with symbols; storage conditions, which may be expressed with symbols; the name, city and country of the manufacturer or primary manufacturer; the manufacturing site, where applicable; the expiry date, where applicable; the service life, where applicable; the storage temperature, where applicable; the batch number or serial number; the registration number; and the legends, which may be expressed with images or symbols.

The 4 legends listed by Article 49 are: consult the instructions for use or user manual accompanying the product before using it; sterile, for sterile products; single use or do not reuse, for sterile devices not intended for reuse; and protect from light, where applicable.

3. Expert insights

Insight one: the label may be in English, but the instructions for use must be in Spanish — the two language rules are different. Article 49 permits the label to be presented in Spanish or English, while item 1.3 of Article 24 and Article 52 require the instructions for use to be written in Spanish, with other languages permitted in addition. These are two different thresholds that are routinely confused in practice.

Insight two: Article 49 demands the 13 items on both the primary and the secondary container — it is not an either-or rule. The text states expressly that the labels of both the primary container and the secondary container must be written in Spanish or English and must carry the listed information. A carton label alone, with no compliant primary packaging label, does not satisfy the requirement.

Insight three: Article 51 provides an exemption channel for the primary container. Where the nature of the primary container label makes it impossible to include all the information, an exemption applies — but the scope of the exemption must be determined under the ARCSA rules and cannot be self-declared. The dossier should state the reasons for the exemption proactively.

Insight four: Article 52 places the instructions for use under formal approval. The text requires the text of the instructions for use or user manual to be submitted as part of the registration file for evaluation and approval. This means the approved manual carries regulatory weight and must not be modified after market entry — any change must go through the change procedure.

Insight five: the final labelling duty of Article 27 is a two-stage design. At the application stage the company submits a label draft under item 1.2 of Article 24; after the certificate is granted, the final label bearing the printed registration number must be submitted within 1 year and before commercialisation, under Article 27. The two documents have different legal status and neither can replace the other.

Insight six: Article 48 brings the container material into the registration review. Containers must be made of materials that do not react physically or chemically with the product and do not alter its quality, safety or efficacy; light protection must be provided where necessary. Packaging itself is therefore reviewed as a compliance element of the product.

4. Practical recommendations

1. Plan the language of labels and manuals separately: the label may be anglicised, but the instructions for use must be localised into Spanish.
2. Check the primary and the secondary container against the 13 items of Article 49, never the carton alone.
3. Freeze the instructions for use at submission: because the manual is subject to approval, later modifications must follow the change procedure.
4. Declare the Article 51 exemption proactively: where the primary container cannot hold all the information, state the reasons in the dossier.
5. Build a compliance calendar for the final label: the binding deadline is whichever comes first between 1 year after certification and the start of commercialisation.

5. Verification checklist

• □ Labels are in Spanish or English, with clear and indelible characters.
• □ Labels of both the primary and the secondary container include the 13 items of Article 49.
• □ The 4 legends have been marked where applicable.
• □ The instructions for use have been written in Spanish, with other languages permitted in addition.
• □ The instructions for use have been submitted for approval as part of the registration file.
• □ A container material compatibility statement is on file under Article 48.
• □ The final label submission has been entered in the post-certification compliance calendar.

Regulatory information verified as of October 29, 2026

GRZAN supports manufacturers, importers and authorised representatives designing compliant labels and instructions for use for the Ecuadorian market, from Article 49 element mapping and Spanish manual localisation to final labelling calendars. For tailored assistance with your Ecuador medical device registration, contact us at info@grzanglobal.com.