Special Authorisation Exceptions Under Article 42

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Regulation for the Sanitary Control of Medical Devices and Other Devices of Sanitary Interest, authorises ARSA under Article 42, in exceptional cases, to permit the import and use of devices without a sanitary registration obtained in advance, provided that the corresponding special authorisation is applied for under this regulation and that compliance with safety, quality and efficacy standards is ensured with no sanitary alert. The provision lists 5 situations: 1 disasters and national emergencies formally declared by decree of the executive branch; 2 donations to the State or to charitable institutions (subject to prior ARSA authorisation); 3 devices for use in clinical trials (protocols approved by an ethics committee authorised by ARSA); 4 devices for the exclusive use of one person or a small number of persons for medically justified reasons (a valid sanitary registration in the country of origin is required, and it must be stated on the primary or secondary label); 5 devices procured by PAHO / WHO and the United Nations (a sanitary authorisation issued by the national regulatory authority of the procuring country must be submitted). The GRZAN regulatory team notes that Article 42 and the special import authorisations of Article 71 work as a pair — Article 42 supplies the exceptional situations, and Articles 71 to 75 supply the procedures.

• Exceptional import still requires the corresponding special authorisation under the regulation.
• Five situations qualify: declared disasters and emergencies, donations, clinical trials, named-patient devices, and PAHO / WHO and UN procurement.
• Donations require prior authorisation from ARSA.
• Clinical trial protocols require approval by an ethics committee authorised by ARSA.
• Named-patient devices need a valid registration in the country of origin, stated on the primary or secondary label.

2. Legal basis

The provisions below set out the five exceptional situations and the special import authorisations that implement them.

3. Expert insights

Insight one: Article 42 is an exception, not a fast track. The provision opens with the words de manera excepcional and still requires the corresponding special authorisation, compliance with safety, quality and efficacy standards, and the absence of a sanitary alert. Reading it as a routine route for importing without registration is a misreading — each category of exception carries its own authorisation procedure, and what is waived is only the sanitary registration itself.

Insight two: item 4 carries two proof requirements of its own. The provision requires that devices for the use of one person or a small number of persons hold a valid sanitary registration in the country of origin, and that this registration be stated on the primary or secondary label. These are verifiable hard conditions, distinct from the emergency use authorisations of strictly regulated authorities under Articles 72 and 73; the two proof systems cannot be mixed.

Insight three: item 5 treats PAHO / WHO and United Nations procurement separately. The provision requires a sanitary authorisation issued by the national regulatory authority (ARN) of the country of procurement. This gives international organisation procurement a clear channel, and it explains why Articles 72 and 73 place orphan devices and devices used by medical teams that will be returned to their home country within the scope of the AEG and AENG.

Insight four: disasters and emergencies require a decree of the executive branch. Article 42.1 and items 2 of Articles 72 and 73 all stress that the state of affairs must be formally declared by decree (Decreto) of the executive branch. This means that a company’s own judgment that an emergency exists is not a basis; the officially published decree governs, and its text should be retained.

Insight five: clinical trial devices require a double approval. Article 42.3 requires the protocol to be approved by an ethics committee authorised by ARSA; item 4 of Article 86 further specifies that the Bioethics Committee for Biomedical Research (CEIB) of the National Autonomous University of Honduras (UNAH) is responsible for evaluation and approval, that ARSA issues the trial authorisation, and that the trial sites must also hold an ARSA premises licence. Taken together the three requirements form a triple approval of ethics, administration and premises.

4. Practical recommendations

• Manage the 5 situations of Article 42 as an exception list and confirm, category by category, whether the corresponding decree, agreement or approval documents exist.
• For named-patient devices, prepare proof of a valid registration in the country of origin and make sure it appears on the label.
• For international organisation procurement projects, prepare the sanitary authorisation issued by the ARN of the procuring country.
• Treat disasters and emergencies as valid only when formally declared by decree of the executive branch, and retain the decree text.
• For clinical trial devices, prepare the triple package of ethics committee approval, ARSA trial authorisation and premises licence.
• For every exceptional import, apply in parallel for the corresponding special authorisation under Articles 71 to 75; the procedures are not waived.

5. Verification checklist

• □ The applicable exception category has been confirmed against the 5 situations of Article 42
• □ Proof of valid registration in the country of origin and the label requirement are in place for named-patient devices
• □ The sanitary authorisation of the procuring country ARN has been obtained for international organisation procurement
• □ The decree text of the executive branch is retained for disaster or emergency situations
• □ Ethics approval, ARSA authorisation and premises licence are in place for clinical trial devices
• □ The corresponding special authorisation has been applied for in parallel for every exceptional import

Further reading: [Article 36 — The three special import authorisations](/honduras-medical-device-registration/special-import-authorisations-aeg-aeng-aep/) | [Article 38 — The donation authorisation](/honduras-medical-device-registration/donation-authorisation-article-76/) | [Article 49 — The regulatory timeline 2020 to 2026](/honduras-medical-device-registration/honduras-regulatory-timeline-and-180-days/)

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