The Fourteen Registration Requirements for Medical Devices in Nicaragua

1. Key takeaways

The dossier checklist for sanitary registration of medical devices in Nicaragua consists of 14 items in Chapter 6 of NTON 24001:2023, ranging from the payment receipt (ROC) to commercial samples. Items 4, 5 and 6 are the three powers of attorney that must first be approved by the Legal Advisory Section (Sección de Asesoría Jurídica, SAJ) of ANRS; items 7 to 10 are four categories of certificates (CLV, ISO 13485, CE and electrical safety); item 12 is the product monograph with 12 sub-items; and item 13 covers samples. The checklist contains no standalone clinical documentation item, because the clinical evaluation is folded into sub-item 12.b of the product monograph.

• The governing instrument is NTON 24001:2023, published in La Gaceta No. 192 on 21 October 2024.
• Three items are powers of attorney that must first be approved by SAJ, covering the legal representative, the registration professional and import, distribution and commercialisation.
• Four items are certificates (CLV, ISO 13485, CE and electrical safety), each with its own conditions of applicability and legalisation chain.
• The product monograph in item 12 has twelve sub-items from a to l, including the clinical evaluation, biocompatibility, stability and the technical vigilance plan.
• Item 14 delegates to DDM the periodic publication of the list of products subject to laboratory analysis and the required sample quantities.

2. Legal basis

The table below maps each of the fourteen dossier items to its source provision, so that every entry is traceable to a numbered item of Chapter 6.

3. Expert insights

Insight 1: there is no standalone clinical documentation item on the checklist. The clinical evaluation is sub-item 12.b of the product monograph, and it is tiered by risk class: NOTA 1 makes it mandatory for class III and class IV devices, while NOTA 2 provides that for class II it depends on the intended therapeutic or diagnostic claims. This differs from markets where the clinical dossier is filed as a separate volume. Companies mapping their dossiers frequently overlook this item, and the omission often surfaces only at the evaluation stage.

Insight 2: the three SAJ approvals are the most time-consuming part of the checklist. Items 4, 5 and 6 cover three separate chains of authorisation, for the legal representative, the registration professional and the distribution authorisation respectively, and each must be approved by SAJ in advance. RA 0001/2026, issued on 5 February 2026 with immediate effect, moved the processing of the five categories of powers of attorney fully online, eliminated paper submission and repealed RA 0031/2024. The format has changed, but the requirement of prior SAJ approval remains in force.

Insight 3: the four certificates are conditionally mandatory, not “collect all four”. The CE certificate is mandatory only for European Union manufacturers (item 9, Aplicado obligatoriamente a fabricantes de la Unión Europea); the FDA certificate is mandatory only for products manufactured in the United States (closing sentence of item 7); the electrical safety certificate applies only to devices or equipment operating connected to electricity (item 10); and the CLV or its equivalent applies across the board. After filtering by origin and product format, most companies actually need to submit only two or three of the four.

Insight 4: item 14 hands the list of products subject to laboratory analysis to DDM for periodic publication, and makes explicit that samples used for laboratory analysis are independent of samples submitted to DDM. The sample quantity is therefore not a fixed number, and there is no practice of preparing “the same as last time”. Before every submission, the currently published list must be retrieved and followed.

Insight 5: the legalisation requirements are tiered across the certificates. The CLV (item 7) requires an original or a notarially certified copy, Spanish or a notarially certified translation, and an apostille or consular legalisation. The ISO 13485 certificate and the electrical safety certificate (items 8 and 10) require an apostille or consular legalisation only where the certificate carries no verification mechanism. Different certificates therefore carry different requirements, and they do not align automatically.

Insight 6: the NOTA to item 12 provides the only waiver channel in the checklist: manufacturers holding an ISO 13485 certificate issued by a body whose accreditation is recognised under MDSAP may waive the cited sub-items. This is the single relief mechanism on the list, and it is where the real value of ISO 13485 in Nicaragua lies.

4. Practical recommendations

• Run the origin and format filter first: determine which of the four certificate categories actually apply, and do not prepare the full set.
• Schedule the three SAJ approvals at the front of the timeline: the powers of attorney are a serial prerequisite, and each must first complete foreign legalisation by apostille or consular legalisation.
• Do not file the clinical evaluation as a separate volume: write it into the product monograph following the seven elements of sub-item 12.b, and confirm whether it is mandatory for your risk class.
• Before submission, retrieve the published list of products subject to testing and the sample quantities under item 14, keeping samples for DDM and samples for laboratory analysis as two separate quantities.
• Verify the legalisation chain certificate by certificate: original or notarially certified copy, Spanish or notarially certified translation, and apostille or consular legalisation, with all three layers complete.
• Assess whether your ISO 13485 certificate was issued by a body recognised under MDSAP; if so, claim the exemption under the NOTA to item 12, while still submitting sub-items g to l.

5. Verification checklist

• □ The applicability of the four certificate categories has been confirmed by origin and product format
• □ Processing of the three SAJ approvals has been initiated, and foreign powers of attorney have completed apostille or consular legalisation
• □ The clinical evaluation has been incorporated into the product monograph following the seven elements of sub-item 12.b, and its mandatory status confirmed by risk class
• □ The currently published list of products subject to testing and the sample quantities have been retrieved (Chapter 6, item 14)
• □ The three-layer legalisation chain of each certificate has been checked: original or notarially certified copy, Spanish or notarially certified translation, and the added legalisation
• □ Whether the ISO 13485 certificate meets the MDSAP-recognised issuing condition has been assessed, and the exemption claimed under the NOTA to item 12

Related reading: [What the official application form asks for: information on five parties](/nicaragua-medical-device-registration/official-application-form-five-parties/) | [The six-month validity of the ROC payment receipt](/nicaragua-medical-device-registration/roc-payment-receipt-six-month-validity/) | [The five stages of registration: preliminary review, evaluation, issuance, first-import analysis and release](/nicaragua-medical-device-registration/five-stage-registration-process/)

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 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