Labelling: Primary and Complementary Labels

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, divides labelling requirements into three sections in Article 84: Section 1, the primary label with 18 items (trade name, generic name, product holder name, manufacturer name, country of origin, product presentation, brand, reference code / model / series / presentation size / catalogue number, lot number, list of ingredients or qualitative and quantitative percentage concentrations, declaration of medicinal or biological ingredients, sterile symbol, sterilisation method, single-use statement, IVD use statement, date of manufacture, expiry date, and net content in International System units); Section 2, the complementary label with 11 items (trade name, generic name, ARSA sanitary authorisation number, reference code / model / series / presentation size, date of manufacture, expiry date, net content in International System units, product holder name, manufacturer name, country of origin, and warnings and prohibitions on sale, among others); Section 3, nine labelling conditions (clear and legible; not detached under normal handling; written in Spanish, failing which a translation legalised by the Ministry of Foreign Affairs is required; material that adheres firmly without compromising packaging integrity; may be printed on the reverse provided it remains legible through the packaging; all three packaging levels must comply; where there is no packaging, the primary packaging must meet all requirements; where the primary packaging is too small, the complementary label may be attached to the secondary or tertiary packaging or included in the technical datasheet and insert; and internationally recognised symbols may be used provided they are explained in the instructions or insert). The GRZAN regulatory team notes: the ARSA authorisation number in item 3 of the complementary label is the only visible link between the label and the registration, and it must be applied to every packaging level once the certificate is granted.

2. Legal basis

The table below maps each labelling requirement of Article 84 to its provision and key point.

3. Expert insights

Insight 1: the division of labour between the primary and complementary labels is product information versus authorisation information. The 18 primary-label items make the product itself identifiable (who made it, what it is, which lot, when it expires); the 11 complementary-label items add on top the ARSA sanitary authorisation number and warning and sale-prohibition wording. This design means the same primary label can be shared across markets, while the complementary label must be remade locally — this is the precise location of localisation cost.

Insight 2: the Spanish-language requirement has a clearly defined exception route. Article 84, Section 3 c), states that labels must be written in Spanish, failing which they must be translated and legalised by the Ministry of Foreign Affairs (relaciones exteriores). This belongs to a different system from the translation and authentication requirement for foreign documents in Article 32, item 12 — labels follow the Foreign Affairs legalisation route, while documents follow apostille or consular authentication; the two routes must not be mixed.

Insight 3: Section 3 h) offers a pragmatic mitigation for small packages. The provision allows that where the primary packaging is too small to carry the complete complementary label, the label may be attached to the secondary or tertiary packaging, or included in the technical datasheet and insert. This matters greatly for small devices (single catheters, small implants): packaging need not be redesigned for labelling, but the dossier must state which option was chosen.

Insight 4: symbols and colours may be used only if explained. Section 3 i) permits internationally recognised symbols and colours, but requires a textual explanation in the instructions or insert. This pairs with Article 43, item 13 (the sterile symbol requires ISO documentation): a symbol is not a pass to skip explanation.

Insight 5: the authorisation number on the complementary label is the source of the back-application obligation. Article 84, Section 2 c), requires the complementary label to state the ARSA sanitary authorisation number, while Article 43, item 12, requires the complementary label draft at the application stage. In practice the draft is filed first and the actual number applied once the certificate is granted; the GRZAN regulatory team recommends stating in the dossier that the authorisation number will be filled in after the certificate is granted, to avoid the label draft being deemed inconsistent with the authorisation.

4. Practical recommendations

• Turn the 18 primary-label items into a checklist; confirm which items the original label already covers and fill gaps on the complementary label.
• Remake the complementary label uniformly for the Spanish-speaking market, fixing the ARSA authorisation number and warning wording as standard fields.
• Process translations of non-Spanish labels through the Foreign Affairs legalisation route, separately from document apostille or authentication.
• For small packages, choose the attachment option under Section 3 h) (secondary or tertiary packaging, or the technical datasheet and insert) and state it in the dossier.
• Where symbols and colours are used, give the textual explanation in the instructions or insert.
• When submitting the complementary label draft at the application stage, note that the authorisation number will be filled in after the certificate is granted, then apply the actual number.

5. Verification checklist

• □ The 18 primary-label items have been checked one by one and the gaps closed
• □ The complementary label has been remade with 11 items, including the authorisation number field and warning wording
• □ Translations of non-Spanish labels have been legalised by the Ministry of Foreign Affairs
• □ Small packages have a chosen attachment option, stated in the dossier
• □ Symbols and colours are explained in the instructions or insert
• □ The complementary label draft notes the pending authorisation number, and the actual number has been applied after the certificate

Related reading: [Article 27 — Samples and the prohibition-of-sale marking](/honduras-medical-device-registration/medical-samples-labelling-article-85/) | [Article 31 — The Titular and the registering company](/honduras-medical-device-registration/titular-and-registrante/) | [Article 30 — Foreign documents and powers of attorney](/honduras-medical-device-registration/foreign-documents-translation-and-apostille/)

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Honduran market. Our team manages Secretariat of Health (SESAL) registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com