Class I Dossier: The Sixteen Registration Requirements

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, lists in Article 43 sixteen dossier items for Class I device registration: 1 the application form (with 18 groups of information); 2 the new-registration declaration form; 3 the free sale certificate (CLV); 4 the manufacturer’s good manufacturing practice certificate (BPM); 5 the quality control specification applicable to the device; 6 the safety report (which must include existing sanitary vigilance records); 7 the vigilance corrective action report validated by the product holder (where applicable); 8 the risk management report; 9 the manufacturing or contract manufacturing agreement when the registering company claims to be the product holder; 10 a copy of the company deed or sole trader registration; 11 the primary, secondary and/or tertiary packaging labels; 12 the complementary label; 13 the ISO conformity supporting document when the label bears the word sterile or a similar wording or symbol; 14 a copy of the legal representative’s professional licence; 15 the power of attorney granted to the authorised attorney (notarised deed or letter of attorney with certification); 16 the proof of payment of fees. In addition, biomedical equipment, IVDs and medical disinfectant and antiseptic products must add six, six and seven items respectively. The GRZAN regulatory team notes: Article 43 is the common base for the other three classes — Articles 44, 45 and 46 all start from the items listed in Article 43 and add to them.

2. Legal basis

The table below maps each dossier item of Article 43 to its provision and key point.

3. Expert insights

Insight 1: four of the sixteen items are report-type documents and are easily mistaken for formatting material. Item 6, the safety report (which must include existing sanitary vigilance records), item 7, the corrective action report validated by the product holder, and item 8, the risk management report, together with item 5, the quality control specification, are the written implementation of the five basic principles of Article 6. The GRZAN regulatory team recommends that the safety report proactively search for and include the device’s international vigilance records; omitting them is treated as insufficient evidence under Article 87, items 1 and 2.

Insight 2: item 9 turns the question of who may claim to be the product holder into a documentary question. The provision states that when the registering company claims to be the product holder, a manufacturing or contract manufacturing agreement must be submitted. This means that a contract manufacturing company must obtain contractual authorisation from the manufacturer in advance; otherwise it can only file as the registering company, and the product holder named in the dossier should still be the actual product holder. This point is frequently overlooked, leaving the application form inconsistent with the agreement.

Insight 3: item 13 is the evidentiary switch for sterile claims. The provision requires that when the label bears the word estéril or any other similar characteristic or symbol, a document supporting conformity with ISO specifications must be submitted. In other words, whether this document is required depends on what the label says. When localising labels, bind the sterile wording to its supporting document so that a label change does not leave the document behind.

Insight 4: the 18 groups of information in the application form must cover four parties at once. Consistent with Article 32, Article 43, item 1, letters d) to k), requires the registering company, the domestic distributing company, the product holder, the manufacturer and — where the purchase is not direct — the international intermediary distributor. The GRZAN regulatory team notes: the four-party information in the risk classification report and the registration application must match word for word, especially addresses and email addresses; inconsistency is the most common source of non-conformity findings.

Insight 5: the three supplementary lists are triggered by product type, not by risk class. The biomedical equipment, IVD and disinfectant and antiseptic supplements in Article 43, Sections 1 to 3, apply to all classes (Articles 44, 45 and 46 all require Article 43 to be satisfied first). A Class III IVD must therefore submit both the four Class III tests and the six IVD supplements of Article 43, Section 2.

4. Practical recommendations

• Write the three reports of items 6, 7 and 8 point by point against the five principles of Article 6, not as generic templates.
• Proactively search for and include the device’s existing international sanitary vigilance records in the safety report.
• Contract manufacturers should obtain the manufacturing or contract manufacturing agreement in advance and confirm the contracting parties match the application form.
• Where the label bears the word sterile or a similar symbol, prepare the ISO conformity supporting document at the same time.
• Compare the four-party information in the risk classification report and the registration application word for word, especially addresses and emails.
• Check the supplementary lists for biomedical equipment, IVDs and disinfectant and antiseptic products separately by product type, not by class.

5. Verification checklist

• □ The sixteen dossier items have been counted one by one against Article 43
• □ The safety report includes existing sanitary vigilance records found by proactive search
• □ Contract manufacturers hold a manufacturing or contract manufacturing agreement with matching parties
• □ ISO conformity documents are ready for labels bearing sterile claims
• □ Four-party information in the classification report and the application has been compared word for word
• □ Product-type supplementary lists have been checked separately by type

Related reading: [Article 22 — What Class IIA adds](/honduras-medical-device-registration/class-iia-iso-13485-and-software/) | [Article 26 — Primary and complementary labels](/honduras-medical-device-registration/labelling-primary-and-complementary/) | [Article 28 — Additional IVD materials](/honduras-medical-device-registration/ivd-specific-requirements/)

Regulatory information verified as of October 29, 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