The Five-Stage Registration Process: From Pre-Evaluation to Release

1. Key takeaways

The actual Nicaraguan process for sanitary registration of devices has five stages: pre-evaluation, technical evaluation, issuance of the certificate, first-import quality check, and the release letter. The first three are governed by Articles 2, 4 and 6 of Chapter 7 of NTON 24001:2023 and by Articles 11 and 12 of Annex I of RA 0007/2025; the last two by Article 8 of Chapter 7 of NTON and Article 14 of Annex I. Even after the registration certificate is issued, the first-import quality check must be passed and the release letter obtained before the product may be freely commercialized — the date of issuance of the registration certificate is not the date from which sale may begin.

2. Legal basis

The five stages draw on the technical standard for their substance and on the administrative decision for the procedural counts. The key provisions are set out below.

3. Expert insights

Insight 1: two of the five stages occur after the registration certificate is issued. Article 6 of Chapter 7 issues the certificate; Article 8 of Chapter 7 then opens the first-import quality check, and item 8 of Article 14 of Annex I issues the release letter. Treating the receipt of the registration certificate as the end of the project is the most common scheduling error in Nicaraguan projects — after issuance there remain four steps: applying for the quality check, on-site sampling, laboratory analysis and the release letter.

Insight 2: the release document does not have the same name for first import and for renewal. Checking the text of Annex I of RA 0007/2025 in this volume: item 8 of Article 14 (first import of a new registration) issues the «carta de Autorización de Primera Importación»; item 7 of Article 15 (market surveillance sampling after renewal) issues the «carta de Autorización de Comercialización». Both are issued within a maximum of 3 working days, but the names and the situations in which they apply differ, and they should not be used interchangeably when filing.

Insight 3: the window for applying for the first-import quality check is 15 working days after customs clearance. Note 1 of Article 14 of Annex I states «en un tiempo no mayor de 15 días hábiles posterior a la nacionalización del producto» — no more than 15 working days after nationalization of the product. The trigger is customs clearance of the goods, not the date the registration certificate was issued. The consequence of exceeding the period is that the DDM takes administrative measures within its powers; the provision does not list the specific measures.

Insight 4: the goods are held until the analysis results are available. Both Article 8 of Chapter 7 and item 3 of Article 14 of Annex I state «el producto estará retenido hasta que se obtengan resultados del análisis». This means the first-import batch cannot be sold or transferred before release.

Insight 5: there are two possible sampling bodies, which may attend separately or jointly — the health vigilance department of the DDM or the Quality Control Laboratory Directorate. Item 3 of Article 14 of Annex I says «o conjuntamente». Sampling takes place within the premises of the establishment («las instalaciones del establecimiento»), not at customs or in a third-party warehouse.

Insight 6: pre-evaluation and technical evaluation are different in nature. Article 2 of Chapter 7 says «se verifica el cumplimiento de los documentos requeridos» — compliance with the required documents is verified — which is a formal review; the technical content is examined at the evaluation stage. A rejection at pre-evaluation therefore normally means missing documents or formal defects, and should not be read as a technical rejection of the product.

4. Practical recommendations

• Schedule across all five stages and do not treat certificate issuance as the end of the project: list the quality-check application, sampling, analysis and release letter as separate planned steps.
• File the first-import quality-check application within 15 working days counted from the customs clearance date, and notify the DDM when the goods arrive (Chapter 7, Article 8).
• Do not arrange sales or transfers of the first-import batch before the release letter is issued; manage the goods as held stock.
• Distinguish the two release documents when filing: «Autorización de Primera Importación» for first import of a new registration, and «Autorización de Comercialización» for sampling after renewal.
• When a pre-evaluation is rejected, treat it first as missing documents or a formal defect and check item by item against the 14-item documentation list of Chapter 6.
• Pay the quality-check fee in advance at the current RM 347-2023 rate: Note 2 of Article 14 of Annex I requires payment before the quality-check application can be processed.

5. Verification checklist

• □ Scheduled across the five stages, with the first-import quality check and release letter listed separately
• □ Confirmed that the first-import quality-check application runs from the customs clearance date and filed within 15 working days
• □ Notified the DDM of the arrival of the goods when they arrived (Chapter 7, Article 8)
• □ Managed the first-import batch as held stock, with no sale or transfer before the release letter was issued
• □ Paid the quality-check fee at the current RM 347-2023 rate and obtained the payment receipt
• □ Filed release documents under the correct name, distinguishing the first-import release letter from the post-renewal release letter

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Nicaraguan market. Our team manages Ministry of Health (MINSA) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com