Paraguay Medical Device Registration 2026: Spanish Labelling and Instructions for Use

1. Key takeaways

1. Article 6, item g) requires that labels and instructions for use be translated into Spanish (rotulado e instrucciones de uso).
2. The label content (Article 19) must state: the manufacturer, the importer and the distributor (where applicable), the technical responsible party, and the approved conditions of sale, together with the wording AUTORIZADO POR DINAVISA and the number of the sanitary registration certificate or the NSO.
3. A complementary label (etiqueta complementaria) is permitted, but its content may only add to or supplement the main label; it must not repeat what the main label already states.
4. When a label change is filed, the operating instructions Article 14 require the current label draft and the updated draft to be submitted simultaneously on DINAVISAPy, with the declared modifications marked within the same document.
5. The wording AUTORIZADO POR DINAVISA is not decorative: it is the marker that connects the physical product to the registration record, and a label without it, or with an inconsistent certificate number, is treated as an unregistered presentation of the product.

2. Legal basis

The resolution carries the substantive labelling obligations, from the Spanish language requirement in item g) to the mandatory content in Article 19, while the operating instructions govern the mechanics of label-related filings through Articles 14 and 15, including how complementary labels may be used and how change submissions must present the two drafts. Article 25 of the resolution reinforces the framework by tying the label back to the registered presentation of the product, which is why labelling evidence is checked both at filing and whenever a change touches the label. A label that drifts from the registration record creates a mismatch that surfaces in the most inconvenient places: import clearance, distribution audits and post-market inspection. Because the mandatory content is fixed, the design freedom lies in layout and language, not in what the label must carry.

3. Expert insights

Insight one: the label is the physical carrier of the registration decision, and any change to it is a change matter. The label carries the approved conditions of sale and the certificate number, both of which are elements of the registration decision itself. A label redesign is therefore never a pure packaging exercise; it must be routed back through the change classification of Article 13: changes that are purely visual and leave the technical information untouched fall into Class I changes and may be implemented immediately, while changes that affect technical information or the conditions of sale fall into Class II changes and require approval before implementation. The classification decision should therefore be documented at the moment the change is designed, with the reasons recorded, so that the implementation timing is defensible if the reviewer later disagrees.

Insight two: the rule that a complementary label must not repeat the main label is often misread as permission to cover. Article 15 of the operating instructions states that the complementary label may only provide additional or supplementary information and must not duplicate the main label. In practice, using a complementary label to cover non-conforming elements of the English original label of the country of manufacture is a non-compliant shortcut; the correct path is to redesign the main label itself in its Spanish version, so that the mandatory content of Article 19 appears on a single, self-consistent label. The complementary label remains useful for genuine additions, such as extra languages or distributor details, precisely because it supplements rather than replaces.

Insight three: the two-draft comparison required for change filings is a review-friendly design, and ignoring it is costly. Article 14 requires the current draft and the updated draft to be submitted together, with the modifications marked inside the same document, so that the reviewer can perform a direct difference comparison. Companies that upload the two drafts as separate files or omit the marking will receive a deficiency and spend one rectification window of 60 business days repairing a formatting issue rather than a technical one. Preparing the marking inside the same file is a formatting discipline best fixed in the template used by the graphics team, so that every label change inherits it automatically.

4. Practical recommendations

1. During label design, fix the block containing the approved conditions of sale, the wording AUTORIZADO POR DINAVISA and the certificate number as a permanent zone that does not move with marketing redesigns, so that marketing teams never relocate the regulatory zone during artwork updates.
2. Produce the main label directly in its Spanish version, and never use a complementary label to cover English content.
3. Assemble label change submissions as a single document containing the current draft, the updated draft and the modification markings, using a marked-up master copy rather than a free-text cover note.
4. Classify every label change before filing: Class I changes may be implemented immediately, while Class II changes must wait for approval after the 45-business-day evaluation period, and the evidence of the classification decision should be kept with the change record.
5. Keep a controlled master copy of the Spanish label in the regulatory file, so that every printed version can be traced back to an approved draft during audits.

5. Verification checklist

• □ Label and instructions for use fully translated into Spanish
• □ Label states the manufacturer, importer / distributor, technical responsible party and conditions of sale
• □ Label carries the wording AUTORIZADO POR DINAVISA and the certificate number
• □ Complementary label contains only additional information and does not repeat the main label
• □ Label change filed as a single document with the current draft, updated draft and markings

Regulatory information verified as of October 29, 2026.

GRZAN provides registration and conformity support in Paraguay for medical device manufacturers, importers and authorized representatives, including Spanish labelling design and change classification under Article 13. For assistance, contact info@grzanglobal.com.