Multiple Registrants and Exclusivity

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Regulation for the Sanitary Control of Medical Devices and Other Devices of Sanitary Interest, allows under Article 40 that 2 or more sanitary registrations for the same device be held by different registering companies, provided that no exclusive distribution arrangement exists between the product owner and a distributor in Honduras; where an exclusive arrangement does exist, the product owner must submit the documents proving its authorisation to carry out the corresponding activities. Article 41 then sets a prohibitive rule: the same natural or legal person may not apply for 2 or more registrations for the same device — the test being that the titularidad (product owner), manufacturer, name, brand, model, series, reference code and similar details are entirely identical. The GRZAN regulatory team notes that the two articles together determine the ownership risk of the registration certificate — whoever funds and files the application becomes the registering company, and if the funding right is handed to the distributor, control of the certificate moves with it.

• Different registering companies may each hold a registration for the same device absent an exclusive arrangement.
• Where exclusivity exists, the product owner must submit documents proving its authorisation.
• Article 41 bars the same person or company from holding 2 or more registrations for an identical device.
• Identity is tested on product owner, manufacturer, name, brand, model, series and reference code.
• Whoever files and funds the application holds the certificate — and its control.

2. Legal basis

The provisions below govern multiple registrations, the exclusivity condition, the prohibition on duplicate applications and the change pathway for the registering company.

3. Expert insights

Insight one: Article 40 makes exclusivity the watershed for multiple registrations. The wording of the provision is siempre y cuando no exista exclusividad entre el titular del producto y un distribuidor en Honduras. This means that whether a second registering company is possible depends on the contractual arrangement between the product owner and the distributor, not on market size or product characteristics. Channel planning must therefore assess the legal consequences of exclusivity clauses at the same time as the commercial terms.

Insight two: Article 41 prohibits duplicate applications by the same entity, not multiple holders each with one registration. The test is a set of entirely identical details: product owner, manufacturer, name, brand, model, series, reference code. Accordingly, one distributor cannot use two entities to obtain two certificates for the same product, while two different distributors each filing one registration without an exclusive arrangement is expressly permitted by Article 40.

Insight three: duplicate authorisation is both a ground for refusal and a ground for cancellation. Article 87.4 lists duplication of an authorisation already issued by ARSA among the grounds for refusal; Article 88.4 lists the same situation as a ground for cancellation. These two articles show that duplication is not limited to a second application being rejected — it can also endanger a registration already obtained. The existing ARSA registrations should be searched before filing.

Insight four: proof of the exclusive arrangement must be submitted at the classification report stage. Item e) vii of Article 32.1 requires the classification report application form to declare whether exclusive distribution rights are held and to attach the evidence; Article 40 requires the product owner to submit the authorisation documents where exclusivity exists. Both provisions point the same way: the exclusive relationship is a fact that must be fixed in writing at the earliest stage, not a statement supplied afterwards.

Insight five: a change of registering company is a ready-made pathway. Article 52.3 l) lists the change of registering company among the 12 types of permissible change, with requirements split by the domicile of the company: domestic companies file paper documents with authentication, while foreign companies file originals with apostille or authentication. The GRZAN regulatory team accordingly recommends that the distribution agreement contain a clause on transferring the registering company on demand, setting out the trigger conditions and the cooperation duties, so that the certificate is not locked into the hands of the distributor.

4. Practical recommendations

• Assess the legal consequences of exclusivity clauses during channel planning: once exclusivity is granted, a second registering company is no longer feasible.
• Declare the exclusive or non-exclusive status in writing at the classification report stage and attach the corresponding evidence.
• Search existing ARSA registrations before filing to avoid the duplication scenarios of Article 87.4 and Article 88.4.
• Never obtain two certificates for the same product through the same entity; use different registering companies when multi-channel coverage is needed.
• Include a clause on transferring the registering company on demand in the distribution agreement, with trigger conditions and cooperation duties.
• When the registering company must be changed, prepare the two document sets required for domestic and foreign companies under Article 52.3 l).

5. Verification checklist

• □ The impact of exclusivity clauses on the feasibility of multiple registrations has been assessed
• □ The exclusive or non-exclusive status was declared in writing at the classification report stage
• □ Existing ARSA registrations were searched before filing, with no duplication risk
• □ The same entity has not applied twice for the same product
• □ The distribution agreement contains the clause on transferring the registering company on demand
• □ The documents for a change of registering company are prepared to both the domestic and foreign requirements

Further reading: [Article 17 — Family grouping](/honduras-medical-device-registration/family-grouping-single-registration/) | [Article 41 — The 12 post-registration changes](/honduras-medical-device-registration/post-registration-changes-twelve-types/) | [Article 31 — Titular and registering company](/honduras-medical-device-registration/titular-and-registrante/)

Regulatory information verified as of 29 October 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