Thirteen Control Mechanisms Under Article 5

1. Key takeaways

Article 5 of Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, lists in one place the 13 instruments ARSA uses to exercise sanitary control over devices and other devices of sanitary interest: 1 sanitary licence (Licencia Sanitaria), 2 risk classification (Clasificación por Riesgo), 3 sanitary registration (Registro Sanitario), 4 sanitary registration exemption (Exoneración de Registro Sanitario), 5 special import authorisation, 6 special donation authorisation, 7 NTDM (authorisation for products used to control the quality of food, drinking water and laboratory water), 8 RUIF (authorisation for devices used only for research and forensic purposes), 9 good manufacturing practice certificate (BPM), 10 good storage and distribution practice certificate (BPAD), 11 good clinical practice certificate (BPC), 12 good technovigilance practice certificate (BPT), 13 good laboratory practice certificate (BPL), while reserving other mechanisms that ARSA may establish as needed.

• The first 3 items are the mandatory route to commercial placing on the market; items 4 to 8 are diversion routes; items 9 to 13 are compliance certificates.
• Decide the route first and the documents second; reversing the order wastes effort.
• The BPM certificate of the manufacturer is a required component of a Clase I dossier under Article 43 item 4.
• Devices containing controlled substances additionally need an import permit issued by the DNPF under Article 32 item 11.

2. Legal basis

The provisions behind the 13 instruments and their use are the following.

3. Expert insights

Insight 1: the first 3 items and the remaining 10 differ in nature and cannot replace each other. The sanitary licence addresses premises and means of transport, risk classification addresses the qualitative conclusion on the product, and sanitary registration addresses the product itself. The typical error the GRZAN regulatory team sees in practice is a company holding the product registration but unable to import for lack of the matching establishment licence, or holding an establishment licence while assuming it may sell directly. All three lines must stand at the same time.

Insight 2: items 4 to 8 are the five diversion routes that avoid registration. Registration exemption (Article 53) covers low-risk products that do not fall within a risk class; special import authorisation (Articles 71 to 75) covers imports not intended for sale; special donation authorisation (Article 76) covers donations; NTDM and RUIF cover the three categories of other devices of sanitary interest in the final paragraph of Article 25. The order of judgement is: first whether the product falls within a risk class, then whether it is intended for sale, and finally whether it belongs to the three categories of other devices.

Insight 3: items 9 to 13 are compliance certificates, not market authorisations. The five certificates BPM, BPAD, BPC, BPT and BPL evidence that premises or activities meet the corresponding practices; they do not replace product registration. Yet Article 43 item 4 lists the BPM certificate of the manufacturer as the fourth required document of a Clase I dossier. A BPM certificate is thus not a market authorisation, but it is a constituent element of the registration dossier.

Insight 4: devices containing controlled substances travel a dual channel. Article 32 item 11 requires that where a device contains a substance regulated by ARSA, an import permit for controlled substances issued by the National Directorate of Medicines and Allied Products (DNPF) must additionally be submitted. Article 75 item 8 repeats the same requirement within the special import authorisation. Scheduling for such products must reserve time for DNPF approval; the timescales of the Devices Directorate cannot be used to count backwards.

Insight 5: the final sentence of Article 5 leaves an interface for new ARSA instruments. After the 13 items, the provision adds other mechanisms as established by ARSA according to its needs. Together with the 180-day supporting legislation window granted by Article 93, further authorisation types can be expected. Compliance lists should be rechecked quarterly; the 13 items must not be treated as a closed list.

4. Practical recommendations

• Draw a route map first: establish whether the product falls within a risk class, whether it is intended for sale, and whether it belongs to the three categories of other devices, and only then select the instrument.
• Advance product registration, establishment licensing and risk classification in parallel instead of waiting in sequence.
• Request the BPM certificate from the manufacturer early for the Clase I dossier, preparing it alongside the registration documents.
• Reserve DNPF approval time for products containing controlled substances, and do not merge it into the timescale of the Devices Directorate.
• Recheck the compliance list quarterly, watching for new authorisation types issued by ARSA.
• Sort the 13 instruments in internal SOPs into mandatory items, diversion items and certificate items, to avoid misapplication.

5. Verification checklist

• □ A route map for the product has been drawn against the 13 instruments of Article 5
• □ Product registration, establishment licensing and risk classification have been scheduled in parallel
• □ The manufacturer BPM certificate needed for the Clase I dossier is being obtained
• □ DNPF approval time has been reserved for products containing controlled substances
• □ The compliance list has a quarterly recheck mechanism
• □ Internal SOPs carry the three-way labelling of the 13 instruments

Regulatory information verified as of 2026-10-29.

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 through the regulatory directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com