Three Authorisations in Order

1. Key takeaways

Placing a medical device on the Honduran market requires three authorisations obtained in a fixed order. The first is the sanitary licence (Licencia Sanitaria) for premises and transport vehicles (Articles 12, 17 and 18), with a validity chosen by the applicant of 2, 4 or 6 years. The second is the risk classification report (CDM / Informe de Clasificación por Riesgo Sanitario) for the product (Articles 31 and 32), valid for 6 months and extendable once (for a further 6 months). The third is the sanitary registration (Registro Sanitario) for the product (Articles 33 and 35), valid for 5 years. The order is fixed by Article 31 and the second paragraph of Article 33: the classification report is a precondition of registration, and items d) and e) of Article 32.1 require the classification report application form to state both the sanitary licence number of the registering company and the valid sanitary licence number of the domestic distributing company — without the first authorisation, the second cannot even be filed. The GRZAN regulatory team notes that these three steps are not parallel options but a serial sequence; placing the classification report after the licence and before the registration is the only workable schedule.

• Sanitary licence for premises and transport: validity of 2, 4 or 6 years chosen by the applicant.
• Risk classification report: valid 6 months, extendable once for a further 6 months.
• Sanitary registration: valid 5 years from the date of issue.
• The classification report form must state the licence numbers of the registering and distributing companies.
• The sequence licence, then classification report, then registration cannot be rearranged.

2. Legal basis

The chain of provisions below fixes both the order of the three authorisations and the validity attached to each of them.

3. Expert insights

Insight one: the order is locked by the provisions, not suggested by experience. Article 31 states that the classification report must be applied for before sanitary registration, and items d) and e) of Article 32.1 require the classification report application form to state the licence numbers of the registering company and the distributing company. Taken together, the three provisions form an unjumpable chain: licence number, then classification report, then registration application. Any attempt to run the steps in parallel will stall at the classification report stage for want of a licence number.

Insight two: the three authorisations have different validity periods, creating three independent clocks. The licence runs 2, 4 or 6 years as chosen by the applicant, the classification report runs 6 months with one possible extension, and the registration runs 5 years. Project planning has to maintain three timelines at once, and the shortest is the 6 months of the classification report — it forces the registration dossier to take shape within half a year, which is where projects in this market most often run out of time.

Insight three: the licence number of the distributing company must be fixed at the classification stage. Item e) of Article 32.1 requires the name, address, email, telephone, valid sanitary licence number and legal representative of the domestic distributing company, together with evidence of any exclusive distribution arrangement. This means that selecting the distributor is not a post-registration matter; it must be settled before the classification report, and changing the distributor later goes through the change procedure of Article 52.3 d).

Insight four: the transport licence is the fourth document most often forgotten. Article 18 provides that transporting biomedical devices, IVDs and other devices requiring special transport conditions requires a separate transport licence, supported by 7 items of vehicle information (brand, model, type, engine number, VIN or chassis number, year and licence plate) and the annual vehicle inspection certificate. Cold-chain projects should schedule this document separately from the rest of the plan.

Insight five: the processing period for the licence has a verifiable official figure. Acuerdo No. 003-2021 (La Gaceta No. 35,552, 23 March 2021), item CUARTO, Table 2, states that the processing period for new and renewed device premises licences is 60 working days and the licence validity is 2 years, with fees calculated as fractions of the minimum average wage. This is one of the few processing periods in this market that can be verified in an official text, and it coexists with the 2, 4 or 6 years selectable under Article 12: the regulation sets the range, while the decision sets the currently available option.

4. Practical recommendations

• Schedule the project serially as licence, then classification report, then registration; do not run the steps in parallel.
• Maintain three timelines at once: licence of 2, 4 or 6 years, classification report of 6 months, registration of 5 years.
• Fix the domestic distributing company before the classification stage and obtain its valid sanitary licence number.
• Schedule the transport licence separately for cold-chain and special-transport products, with the 7 vehicle details and the inspection certificate ready.
• Back-plan the premises licence against the 60-working-day processing period and reserve time for document preparation.
• Mark the classification report expiry date as a critical milestone on the project Gantt chart and check dossier readiness 30 days in advance.

5. Verification checklist

• □ The project Gantt chart arranges licence, classification report and registration serially
• □ Three separate validity timelines have been created and are maintained
• □ The domestic distributing company is fixed and its valid sanitary licence number obtained
• □ The transport licence is scheduled separately, with the 7 vehicle details and inspection certificate ready
• □ The premises licence is back-planned against the 60-working-day processing period
• □ A dossier readiness checkpoint is set 30 days before the classification report expires

Further reading: [Article 13 — Risk classification report, six months](/honduras-medical-device-registration/risk-classification-report-six-months/) | [Article 32 — Sanitary licence and the documents of Article 17](/honduras-medical-device-registration/sanitary-licence-validity-and-requirements/) | [Article 05 — Acronyms and definitions](/honduras-medical-device-registration/acronyms-and-definitions-article-3/)

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