Nicaragua Medical Device Legal Framework

1. Key takeaways

The legal sources for devices in Nicaragua can be arranged in 5 layers: the Constitution (the right to health in Article 59); statutes (Ley No. 423, the Ley General de Salud; Ley No. 1068 creating ANRS; Ley No. 290; Ley No. 292; Ley No. 156); regulations (Decreto No. 001-2003, the regulation of the Ley General de Salud); the mandatory technical standard (NTON 24001:2023); and administrative resolutions and circulars (RA 0007/2025, RA 0020/2025, RA 0001/2026 together with two DDM circulars of 2026). The master standard NTON 24001:2023 was adopted by the CNNC and published in La Gaceta No. 192 (2024-10-21); Chapter 16 provides that it enters into force 90 days after publication, and its Chapter 14 repeals, in one stroke, 4 earlier instruments including Norma 064. GRZAN regulatory team note: Nicaragua writes its device registration requirements as a technical standard rather than as a regulation, and this determines that revisions follow the standardisation procedure of the CNNC instead of a ministerial legislative procedure.

2. Legal basis

The table below lists the five layers in descending order of hierarchy, with the specific provisions relied on and the point each provision settles.

3. Expert insights

Point 1: The NTON is a mandatory Nicaraguan technical standard, and its issuing body is the CNNC, not the Ministry of Health. Section Consideraciones generales C of the main text of Adenda 2026-05 states that NTON 24001:2023 was adopted by the CNNC (Comisión Nacional de Normalización Técnica y Calidad) at its second ordinary session of 2024 and published in La Gaceta No. 192 (2024-10-21). This matters: revisions of the standard follow the standardisation procedure, with drafting, public consultation and adoption by the technical committee, not the procedure for a ministerial regulation issued by the Ministry of Health alone.

Point 2: The CORRESPONDENCIA field of NTON 24001:2023 reads No aplica. The cover page of the standard states CORRESPONDENCIA: No aplica, meaning there is no transposition relationship with any international standard. This stands in sharp contrast with, for example, Costa Rica, where RTCR 505:2022 expressly aligns itself in Article 23 with the Canadian SOR/98-282. The consequence is that no provision of any international standard can be used to presume what Nicaragua requires; the only valid reference is the national text itself.

Point 3: Chapter 3, REFERENCIAS NORMATIVAS, states that no normative references are cited. The master standard cites no normative documents, yet its definitions carry abundant source markings: GHTF/SG1/N071:2012, IMDRF MDCE WG/N56FINAL:2019, ISO 13485:2016, OPS/HSS/MT/22-0024 and WHO communication 2020/03. These sources are informative, they are the origin of terminology, not normative references of the standard, and they cannot be invoked to claim the mandatory application of any international standard.

Point 4: The repeal list in Chapter 14 is a root-and-branch replacement. Items a) to d) of Chapter 14 repeal Norma 064 (Acuerdo Ministerial 144-2011, 2011-05-05), Circular MS-DGRS-MLRG-2026-04-2016 on dossier submission, Circular MS-DGRS-MLRG-2027-04-2016 on sample submission, and the parts of RA 003/2021 concerning device registration. Document checklists on the market that were built around Norma 064 have lost their validity in their entirety.

Point 5: The three administrative resolutions completed the replacement of the procedural law within 14 months. The NTON specifies what must be submitted; the three resolutions specify how it is submitted: RA 0007/2025 (in force 2025-05-02) governs licensing and registration, RA 0020/2025 (in force 2025-10-13) governs imports, and RA 0001/2026 (in force 2026-02-05) governs powers of attorney. Taken together, device applications in Nicaragua had become essentially paperless by early 2026.

Point 6: An international treaty enters the chain of obligations directly. Chapter 5, Article 13 invokes Decreto A. N. N°. 7549, the approval of the Minamata Convention on Mercury (La Gaceta No. 172, 2014-09-10), which from the entry into force of the standard prohibits the manufacture, import, distribution and commercialisation of mercury-containing devices. This is the only product prohibition in this volume that is triggered directly by an international treaty.

4. Practical recommendations

• Run the compliance search in the order of the five layers: check the NTON chapter and article first, then check whether the three administrative resolutions have updated the position, and finally go back to Ley 423 and Ley 1068 to confirm the source of authority. Do not skip layers.
• Retire every document checklist from the Norma 064 era: internal templates, client quotations and project plans that still cite Norma 064 or the two 2016 circulars should be rebuilt against Chapter 6 in all cases.
• Bring standard revisions into your monitoring: NTON revisions follow the CNNC procedure, and public consultations are published at cnnc.gob.ni/elaboracion-de-normas/normas-consulta-publica/, which should be on the annual tracking list.
• Mark every fee as subject to the current published schedule: RM 347-2023 is the current fee basis, but fees can be updated by a new ministerial resolution, so quotations must carry a caveat to that effect.
• Distinguish standards from resolutions in regulatory explanations to clients: the standard answers what must be submitted, the resolutions answer how it is submitted and how long the result takes, and the two update on different rhythms.
• Screen mercury-containing products for market exclusion first: dental amalgam, mercury-column blood pressure gauges, mercury thermometers and similar items are expressly listed in Chapter 5, Article 13 as prohibited from sale and should not be entered into registration plans.

5. Verification checklist

• □ The legal source search has been completed in the order of the five layers and the original texts retained
• □ The provisions relied on have been confirmed as the current text of NTON 24001:2023, with no reference to Norma 064
• □ The entry-into-force dates and scope of the three administrative resolutions have been confirmed
• □ The CNNC public consultation page has been included in the annual regulatory tracking
• □ Quotations and plans mark fees as subject to the current published schedule under RM 347-2023
• □ The market-exclusion screening for mercury-containing categories has been completed
• □ Old numbering in internal templates (Norma 064, the 2016 circulars) has been removed

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 through the regulatory directorate, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com