Titular del producto and the registering company: roles, disclosures and change of holder

1. Key takeaways

Honduras splits the product owner and the registering company into two distinct legal roles. Article 3, Section II of Acuerdo No. 0631-ARSA-2023 defines the Titular del producto as the legal entity responsible for the design, manufacture, conditioning (acondicionamiento) and labelling of the device, and as the owner of all legal and intellectual property rights in the product. The Empresa registrante is the local company that submits the registration application and is recorded under the sanitary registration number. Article 43(1)(d) requires the registering company to report five items of information (name, address, email, telephone and sanitary licence number), where item (v) is its own Licencia Sanitaria number. Under items (i), (j) and (k) of the same provision, the application must also report three groups of entities: the product owner, the manufacturer and the international intermediate distributor (the latter only where the purchase is not made directly from the product owner). The GRZAN regulatory team notes that the regulation does not require the product owner to establish an entity in Honduras. Article 52(3)(j) expressly contemplates the situation in which a foreign product owner issues change documents that must be apostillado or autenticado. A foreign manufacturer may therefore act directly as the Titular, but must appoint a locally licensed company as the registering company.

2. Legal basis

The role separation rests on a compact set of provisions in Acuerdo No. 0631-ARSA-2023. The table below summarises the provisions that define the two roles, govern multi-entity registrations and regulate changes of the product owner.

3. Expert insights

Insight 1: the Titular is a concept of rights ownership; the registrante is a concept of procedural standing. Article 3, Section II defines the Titular along the design–manufacture–conditioning–labelling chain and the ownership of intellectual property, not along the question of who submits the dossier. The duty to submit falls on the registering company. This means the rights holder and the responsible party on the registration certificate are separated: the product owner answers for design defects and vigilance information, while the registering company answers for local distribution and traceability. The six premises obligations of Article 11 and the change-application duties of Article 52 both fall on the registering company.

Insight 2: a single application form discloses three tiers of the supply chain. Article 43(1)(i), (j) and (k) require the name, address, email and website of the product owner, the manufacturer and the international intermediate distributor, with item (k) applying only where the purchase is not made directly from the product owner. A trading route therefore cannot be hidden: as soon as one intermediary sits between the manufacturer and Honduras, the intermediary must be listed in the application. When GRZAN prepares dossiers, it cross-checks the purchasing route against the three entity documents (business licence, chain of authorisations and invoice flow) for consistency.

Insight 3: a registering company claiming to be the titular will be asked for a contract. Article 46, final paragraph, item 9 lists a manufacturing or maquila contract as a mandatory document when the registering company claims the status of titular. In OEM and ODM scenarios, if the Honduran registering company applies in its own name and asserts product ownership, the absence of a maquila contract is a documentation gap. Conversely, if the foreign product owner is truthfully declared, that contract is not required, but the product owner documents must pass through the translation and legalisation chain.

Insight 4: one product owner can map to several registering companies. Article 40 allows the same device to hold two or more sanitary registrations, provided no exclusive distribution arrangement exists between the product owner and the Honduran distributor; where an exclusive arrangement exists, the product owner must submit documents evidencing it. Article 41 then draws the red line from the opposite side: the same natural or legal person is prohibited from applying for two or more registrations for the same device where the titular, manufacturer, name, brand, model, series and reference code are all identical. Together the two articles permit multiple entities but prohibit duplicate applications.

Insight 5: a change of product owner is a registrable change, not automatic succession. Article 52(3)(j) lists Cambio de Titular del producto as one of 12 categories of post-registration changes. The dossier consists of a change declaration issued, signed and sealed by the product owner and apostillised or authenticated, together with primary or secondary packaging labels reflecting the change of manufacturer and country of origin. After a cross-border merger or an intra-group reorganisation, the registration certificate does not transfer automatically; the change procedure must be followed, otherwise the registration number and the actual rights holder diverge.

4. Practical recommendations

• Write the roles into the chain of authorisations first: the letter of authorisation from the product owner to the registering company should state both that the company is authorised to apply for and hold the sanitary registration as the empresa registrante, and that it covers the change applications listed in Article 52, so that each future change does not require a fresh authorisation.
• Treat all foreign product owner documents under Article 32, item 12: translate them into Spanish and obtain the apostillado (Hague member states) or autenticado (non-member states) plus the consular legalisation chain of the issuing country.
• Complete item (k) of the application truthfully: whenever the purchase is not made directly from the product owner, the international intermediate distributor must be reported, with its authorisation or distribution evidence ready for verification.
• In OEM scenarios choose one of two paths: either declare the foreign product owner truthfully, or, where the registering company claims to be the titular, prepare the manufacturing or maquila contract at the same time (Article 46, final paragraph, item 9). Do not leave both routes unresolved.
• Before closing a group reorganisation or an acquisition, schedule the Cambio de Titular change (Article 52(3)(j)) into a 30-day post-closing compliance checklist, and update the product owner name and address on the labels at the same time.
• Where several registering companies operate in parallel for one product, first confirm whether an exclusive distribution agreement exists: with exclusivity, the evidencing documents required by Article 40 must be submitted, otherwise parallel applications will be queried during review.

5. Verification checklist

• □ Entity documents, articles of association and intellectual property ownership statement of the product owner (Titular) are complete
• □ The Licencia Sanitaria number and validity of the registering company have been checked and cover the declared activities
• □ Entity information under items (i), (j) and (k) of the application matches the actual purchasing route
• □ Foreign product owner documents have been translated into Spanish and apostillised or authenticated
• □ Where the registering company claims to be the titular, the manufacturing or maquila contract is ready
• □ Exclusivity status has been confirmed and the evidencing documents required by Article 40 are ready
• □ A change-of-owner contingency plan has been built into the merger or reorganisation timetable

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

Regulatory information verified as of October 29, 2026.