On-Site Inspection and Sanitary Licence Issuance

1. Key takeaways

The on-site inspection for a sanitary licence is carried out by the DDM after the evaluation is passed, within a maximum of 20 working days (Annex I, Article 9, item 1, of RA 0007/2025). Where the inspection finds non-compliance, the DDM records the remedial items and the deadline in the inspection report; after remediation a second inspection may be requested through the system, and a third may be requested if the second also fails, while continued failure leads to cancellation of the application. Once the inspection is passed, the DDM issues the licence within no more than 3 working days (Article 9, item 6). Where an error is discovered in the certificate after it has been collected, there is a 5-working-day window to request a free correction (Article 10, items 1 and 3).

2. Legal basis

The inspection and issuance sequence, including the correction regime after collection, is set out in Articles 9 and 10 of Annex I. The key provisions are summarised below.

3. Expert insights

Insight 1: there are three inspection opportunities, but the text is asymmetric. Items 3 and 5 of Article 9 provide the channels for requesting a second and a third inspection, but the treatment after the third is compressed into a single phrase at the end of item 5 — «De no cumplir lo indicado se dará de baja al trámite» — without the report and remediation deadline spelled out as for the first two. This asymmetry is in the official text; in practice the third inspection should be treated as final.

Insight 2: the correction window is only 5 working days, and it runs from the date of collection. Item 1 of Article 10 says «después de que se le haya entregado la Licencia Sanitaria» — after the sanitary licence has been delivered. Failing to check the certificate details immediately on collection means missing the free correction window outright.

Insight 3: whether a correction is charged depends on the cause of the error, a design specific to the licence track. Item 2 of Article 10 requires the DDM to determine whether the error was caused by the DDM or by the applicant; corrections caused by the DDM are free and take a maximum of 5 working days (item 3), while errors caused by applicant information attract a fee (item 5). These rules are not the same as those for correcting a registration certificate (Chapter 12 of NTON), and the two should not be mixed.

Insight 4: the licence stage has no first-import quality check. Unlike the registration track, the licence track ends once the certificate is issued. Conflating the end points of the two tracks leads either to the faulty logic that a product may be sold as soon as the registration certificate is issued being carried back into the licence track, or to the licence issuance date being mistaken for the date the product becomes sellable.

Insight 5: the 20 working days run after the evaluation and are not concurrent with it. Item j of Article 5 of Annex I sets the licence as three stages — pre-evaluation, evaluation and inspection — and the 20 working days for inspection fall after the 10 working days of evaluation. The predictable duration of the whole licence chain is therefore longer than any single stage suggests.

Insight 6: an inspection is not necessarily triggered. Item 1 of Article 9 carries the qualifier «cuando aplica» — where applicable — indicating that not every licence application triggers an on-site inspection. Whether it is triggered is at the DDM’s discretion, and the text provides no list of exemptions. Companies should plan on the assumption that an inspection will occur, while confirming the position for the individual case with the DDM.

4. Practical recommendations

• Prepare on the basis that the third inspection is final: complete a self-audit before the first inspection and resolve likely non-conformities before the official visit.
• Check the certificate details on the day of collection and file a correction request within 5 working days so as not to miss the free window.
• Explain the cause of the error in the correction request and attach evidence: errors caused by the DDM are free of charge (Article 10, item 3), while those caused by the applicant’s own information attract a fee (item 5).
• Schedule the licence as a serial three-stage chain — pre-evaluation 5, evaluation 10, inspection 20, issuance 3 working days — and do not assume any of it runs in parallel.
• Confirm with the DDM for the individual case whether an on-site inspection will be triggered (Article 9, item 1, «cuando aplica») and prepare the premises accordingly.
• Keep the licence and registration correction rules separate: licence corrections run under Article 10 of Annex I, registration corrections under Chapter 12 of NTON.

5. Verification checklist

• □ Completed a pre-inspection self-audit on the basis that the third inspection is final
• □ Checked the certificate details on the day of collection and filed a correction request within 5 working days where needed
• □ Stated the cause of the error in the correction request with supporting evidence, and determined on that basis whether a fee applies
• □ Scheduled the licence as a serial three-stage chain without assuming parallel processing
• □ Confirmed with the DDM for the individual case whether an on-site inspection will be triggered
• □ Kept the two sets of rules separate: licence corrections (Annex I, Article 10) and registration corrections (NTON, Chapter 12)

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