Cancellation Grounds under Article 88

1. Key takeaways

Cancellation of a registration certificate and prohibition of sale are two distinct tracks. Article 38 of Acuerdo No. 0631-ARSA-2023 first prohibits the sale of products in eight states: expired (caducados), altered (alterados), adulterated (adulterados), contaminated (contaminados), fraudulent (fraudulentos), spurious (espurios), defective (defectuosos) and deteriorated (deteriorados). Article 88 then sets out five grounds for cancelling an authorisation already issued: proof that the device is harmful, ineffective or unsafe under conditions of normal use and constitutes a foreseeable risk; proof that its qualitative or quantitative composition does not match the authorisation, or that it violates the quality and safety guarantees declared in the dossier (to be substantiated by an analysis report issued by a laboratory designated by ARSA); an application by the registration holder itself; duplication of an authorisation already issued by ARSA; and any other situation ARSA concludes upon after a technical-legal analysis.

2. Legal basis

The table below consolidates the sale prohibitions of Article 38, the five cancellation grounds of Article 88, and the quality-control provisions that supply the evidentiary chain leading to cancellation.

3. Expert insights

Insight 1: the eight prohibited states describe the condition of the product, not the conduct of the company. The eight adjectives listed in the first paragraph of Article 38 all point to the state in which the product itself is found, regardless of whether a registration was ever obtained. This also explains why Article 36 (seizure and disposal) and Article 37 (penalties for expired or unauthorised products) follow immediately: an unsatisfactory condition alone can trigger inspection action, without any prior cancellation of the registration.

Insight 2: cancellation item 2 makes a laboratory report the means of proof. Article 88, item 2 requires the finding to be comprobada mediante un reporte de análisis emitido por un laboratorio de calidad establecido por la ARSA — substantiated by an analysis report issued by a quality laboratory established by ARSA. Read together with Article 80 (ARSA laboratories or accredited external laboratories at home and abroad) and Article 82 (testing costs borne by the licence holder), the chain is: sampling, laboratory analysis, report, cancellation — with the cost borne by the licence holder.

Insight 3: item 3 is the only proactive exit. Among the five cancellation grounds, only application by the registration holder is an action a company can initiate itself. When a product leaves the market, is discontinued, or a corporate group is consolidated, applying proactively for cancellation is cleaner than letting the registration lapse — the latter falls into passive handling under Article 37 and the other grounds of Article 88.

Insight 4: item 4 extends duplicate authorisation from refusal to revocation. Article 87, item 4 prevents duplicate authorisation from arising; Article 88, item 4 provides that duplicate authorisation discovered afterwards is to be cancelled. The two provisions together form a complete life-cycle control over duplication.

Insight 5: refusal and cancellation share the substandard-or-counterfeit judgement. Article 87, item 7 (refusal of authorisation) and Article 38, second paragraph, item 4 (withholding of marketing authorisation) both rest on the conclusion of scientific analysis, while Article 88, item 2 approaches through composition inconsistent with the declaration. Their mechanisms of proof differ, but all three land on laboratory analysis and dossier consistency.

4. Practical recommendations

• Write the eight prohibited states into warehouse and channel inspection standards: expired, altered, adulterated, contaminated, fraudulent, spurious, defective and deteriorated — any hit means withdrawal from sale (Article 38).
• Maintain a dossier-consistency ledger: the qualitative and quantitative composition of the authorisation and the quality and safety guarantees declared must remain comparable with every batch actually produced, avoiding the trap of Article 88, item 2.
• When exiting the market, apply proactively for cancellation (Article 88, item 3) instead of waiting for the registration to expire and be handled under Article 37.
• Companies registered through multiple channels should audit once a year for duplicate authorisations (Article 88, item 4) and, where found, proactively apply to cancel one of them.
• Upon receiving a sampling notice, budget for testing and sample transport under Article 82, and cooperate with the two sample batches of Article 81 (analysis sample and retention sample).
• Where an objection to the laboratory analysis report exists, submit review materials before the cancellation procedure advances, and keep complete communication records.

5. Verification checklist

• □ Warehouse and channel inspection standards cover the eight prohibited states of Article 38
• □ A ledger comparing authorised composition with actual batches has been established
• □ The path for proactive cancellation of withdrawn products has been defined
• □ An annual audit mechanism for duplicate authorisations has been established
• □ The sampling cooperation procedure (two sample batches, cost bearing) has been written into SOPs
• □ A responsible person has been designated for review and appeal against laboratory analysis reports

Related reading: [Article 45 — Tecnovigilancia rules and the 72-hour clock](/honduras-medical-device-registration/tecnovigilancia-acuerdo-0185-2025/) | [Article 43 — Eight refusal grounds](/honduras-medical-device-registration/refusal-grounds-article-87/) | [Article 47 — Quality control sampling and cost bearing](/honduras-medical-device-registration/quality-control-sampling-and-costs/)

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