Renewal Dossier: The Twelve Items

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 the final paragraph of Article 46 twelve items for the renewal of the sanitary registration: 1 the renewal application form (with 20 groups of information, three more than for new registrations: the registration number to be renewed, the validity period granted by the original registration, and proof of exclusive distribution); 2 the declaration form specific to renewals; 3 the primary, secondary and/or tertiary packaging labels; 4 the complementary label; 5 the ISO conformity document when the label bears the word sterile or a similar symbol; 6 four additions for biomedical equipment (technical nameplate, service manual, user manual, equipment images); 7 six additions for IVDs; 8 seven additions for medical disinfectant and antiseptic products; 9 the same as item 8 (the provision repeats the list); 10 the seven additions for computer systems of Class IIA and IIB devices; 11 the Class III additions (including the manufacturing summary, the four tests, the finished product analysis certificate and the five categories of equivalent documents); 12 the proof of payment of fees. The GRZAN regulatory team notes: the renewal list does not include the CLV and BPM certificates — unlike new registrations (Article 43, items 3 and 4) — yet these two documents reappear in the Class III equivalent documents list; as a practical estimate, prepare them to the new-registration standard: better more than less.

2. Legal basis

The table below maps each item of the renewal list to its provision and key point.

3. Expert insights

Insight 1: the renewal application form asks for three more groups of information than the new-registration form. Item 1 g) of the final paragraph of Article 46 requires the registration number to be renewed, item 1 h) requires the validity period granted by the original registration, and item 1 d) vii requires proof where the company holds exclusive distribution or distribution rights. These three items are the substantive difference in information gathering between renewal and new registration — the continuity of the registration number and validity period is precisely how the final paragraph of Article 35, keep the original registration number and original dossier number, is implemented.

Insight 2: the renewal list does not separately list the CLV and BPM certificates. Compared with Article 43, items 3 and 4 (mandatory for new registrations), these two items are indeed absent from the twelve renewal items. Yet items 11 a) and b) of the final paragraph of Article 46 list them again within the Class III equivalent documents. The GRZAN regulatory team recommends preparing the CLV and BPM to the new-registration standard even for renewal, because one cannot predict whether the reviewer will demand them along the equivalent-documents route.

Insight 3: the provision repeats the seven disinfectant and antiseptic additions in items 8 and 9. This is an obvious duplication in the official text (the wording of the two items is identical). We record it as it stands without presumption — but as a practical estimate, submit once only; a duplicate submission adds no extra effect. Such textual imperfections also show that when citing provisions the content should govern, with the original text attached to the dossier statement where necessary.

Insight 4: renewal does not simplify the Class III additions. Item 11 of the final paragraph of Article 46 restates in full the content of Article 46, items 2 to 5, including the four tests and the finished product analysis certificate. This means the cost of a Class III renewal is essentially the same as first registration; companies should keep the test documents valid after registration rather than re-running them just before renewal.

Insight 5: the order of renewal versus change is locked by Article 50. The provision states that where the registration has already expired, changes are not processed and the registering company must renew first. Therefore any change (new manufacturer, new presentation, new distributor) must come after renewal; filing the change first leads to outright rejection, wasting precisely the five-month early window of Article 35.

4. Practical recommendations

• Complete all 20 groups of information in the renewal application form, especially the registration number to be renewed and the original validity period.
• Prepare the CLV and BPM certificates to the new-registration standard even for renewal; do not omit them because the list does not name them.
• Submit the seven disinfectant and antiseptic additions once only, despite the repetition in the text.
• For Class III renewals, schedule the four tests with cost and lead time comparable to first registration.
• Place renewal before any change to avoid the rejection scenario of Article 50.
• Start renewal six to eight months before expiry, leaving time for testing and label preparation.

5. Verification checklist

• □ All 20 groups of information in the renewal application form are complete
• □ CLV and BPM certificates have been prepared to the new-registration standard
• □ The disinfectant and antiseptic additions were submitted once
• □ The four tests for the Class III renewal have been scheduled
• □ Renewal has been sequenced before any change
• □ The renewal start point has been set six to eight months before expiry

Related reading: [Article 16 — Five-year validity and the renewal window](/honduras-medical-device-registration/five-year-validity-and-renewal-window/) | [Article 24 — What Class III adds](/honduras-medical-device-registration/class-iii-additional-requirements/) | [Article 41 — The twelve types of post-registration change](/honduras-medical-device-registration/post-registration-changes-twelve-types/)

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