Risk Classification Report Six Months

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Regulation for the Sanitary Control of Medical Devices and Other Devices of Sanitary Interest, states in Article 31 that before obtaining the sanitary registration of a device, a risk classification report (Informe de Clasificación por Riesgo Sanitario, abbreviated CDM) must first be applied for; with that report the authorised activities stated in the sanitary licence may be carried out. The report is valid for 6 months from its date of issue and may be extended once, the extension also lasting 6 months, and it may be requested at any time before expiry; a new device sanitary registration must be applied for before the classification report or its extension expires. The second paragraph of Article 33 adds that the registration application may be submitted from the date of issue of the classification report or of its extension. The GRZAN regulatory team notes that this 6-month clock is the point at which Honduran projects most easily fail — unlike the registration it has no 5-year buffer, and unlike the licence its term is not chosen by the applicant; once it lapses, classification must be applied for again from scratch, with the fees paid again.

• The classification report must be applied for before sanitary registration.
• Validity is 6 months from the date of issue, extendable once for a further 6 months.
• The extension may be requested at any time before expiry.
• A new sanitary registration must be filed before the report or its extension expires.
• The registration application may be filed from the issue date of the report or its extension.

2. Legal basis

The provisions below govern the validity, extension and timing linkage of the risk classification report.

3. Expert insights

Insight one: the 6 months run from the date of issue, not from the date of receipt. Article 31 uses the wording a partir de su emisión. For companies outside Honduras, document forwarding and translation will consume part of that time; the GRZAN regulatory team recommends recording the date of issue as T0 in internal systems and back-planning all dossier preparation from that point, rather than starting the clock only when the paper document arrives.

Insight two: there is only one extension, and it must be requested before expiry. The provision reads pudiéndose prorrogar por una (1) única vez, and allows the request to be made at any time before the report expires. This means the maximum time that can be secured is 12 months (6 plus 6), but only if the second 6 months are also fully used — treating the extension as a buffer without re-planning the project is a classic cause of a second expiry.

Insight three: before the classification report expires it must be converted into a registration, not extended again. The final sentence of Article 31 is explicit: a new sanitary registration must be applied for before the classification report or its extension expires. This positions the classification report as a one-time pass — its function is to carry the product into registration, not to serve as a long-lived determination document. If a product is not launched for a long period, the classification conclusion lapses on its own.

Insight four: the extension application needs clearly fewer documents than a new application. Article 32 requires 13 documents for a new report but only 5 for an extension (the application form, the declaration specific to extensions, evidence of exclusive distribution, tertiary packaging labels and the proof of payment). This difference signals a practical approach: if registration cannot be completed within 6 months, apply for the extension early — fewer documents, lower cost — rather than scrambling at the last moment.

Insight five: the timing linkage between the classification report and registration is expressly required. The second paragraph of Article 33 states that the registration application may be submitted from the date of issue of the classification report or of its extension, so that classification and registration are joined in time. The practical meaning is that the filing date must fall within the validity window of the classification report; a filing outside the window has no procedural basis.

4. Practical recommendations

• Set the date of issue of the classification report as T0, run a 6-month countdown and set a 30-day alert.
• If registration cannot be completed within 6 months, apply for the extension early — only 5 documents are needed — instead of waiting until the last weeks.
• Re-plan the schedule after the extension so that the registration filing lands within the second 6-month window.
• Make sure the registration filing date falls strictly within the validity of the classification report or its extension.
• Start ISO, testing and label preparation in parallel with the classification stage so the window is not consumed by translation.
• Record the classification report number and validity on the cover page of the registration dossier for easy cross-checking.

5. Verification checklist

• □ The date of issue of the classification report is set as T0 with a 6-month countdown
• □ A 30-day pre-expiry alert is in place
• □ If an extension is needed, the 5 documents of Article 32 are ready
• □ The registration filing date is confirmed to fall within the validity of the classification report
• □ ISO, testing and label preparation started in parallel with the classification stage
• □ The dossier cover page states the classification report number and validity

Further reading: [Article 14 — The 13 documents of the classification report](/honduras-medical-device-registration/classification-report-requirements-article-32/) | [Article 16 — Five-year validity and the renewal window](/honduras-medical-device-registration/five-year-validity-and-renewal-window/) | [Article 12 — Three authorisations in order](/honduras-medical-device-registration/three-authorisations-in-order/)

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