Legal Representative and Powers of Attorney in Nicaraguan Device Registration

1. Key takeaways

In Nicaragua the party that actually carries responsibility inside the country is the legal representative of the manufacturer — the representante legal del fabricante. NTON 24001:2023, Chapter 4, definition 39 requires that person to be a natural or legal person established in the country and to hold written authorisation from the legal manufacturer. Chapter 5, Article 7 assigns legal, technical and scientific responsibility for the product to that same party, and Chapter 5, Article 8 requires the authorisation to be apostilled or consularised and legalised. Administrative Resolution No. 0001/2026, issued on 5 February 2026 and effective the same day, moved all five categories of powers of attorney onto Karplus, abolished paper filing, repealed RA 0031/2024, and set a ceiling of 25 powers per registrador, with one registrador for every 25 powers held by a legal person.

• The legal representative must be established in Nicaragua (definition 39); an overseas entity cannot hold the role directly.
• The role is substantive: legal, technical and scientific responsibility for the product sits with it (Chapter 5, Article 7).
• Its authorisation must be apostilled, or consularised and legalised (Chapter 5, Article 8).
• The registration file must contain an SAJ-approved power of the legal representative (Chapter 6, item 4).
• Since 5 February 2026 the five categories of powers are processed through Karplus, with no paper filing.
• Capacity is capped at 25 powers per registrador, and one registrador per 25 powers for a legal person.

2. Legal basis

Two instruments govern this area: the technical standard, which sets the substantive requirements, and the administrative resolution, which sets the processing channel and its caps. The table sets out the provisions relied on below.

3. Expert insights

Insight one: the establishment requirement is the hardest element of definition 39. The phrase «Persona física o jurídica establecida en el país» means an overseas party cannot serve as legal representative — a sharp contrast with the holder under definition 41. Companies routinely conflate the two roles, and the authorisation chain is then built on a false premise.

Insight two: the responsibility is threefold and covers the whole lifecycle. Chapter 5, Article 7 refers to «aspectos legales, técnicos y científicos documentados en la solicitud de registro, modificaciones y renovación» — three families of matters across application, modification and renewal. This is not a formal or nominal role; it is the party on which responsibility is placed.

Insight three: RA 0001/2026 changes the channel, not the substance. Operative parts two and three move the receipt, handling and assessment of the five categories of powers to Karplus and abolish paper filing, and part five repeals RA 0031/2024. The requirement in Chapter 6, item 4 that the power be approved by SAJ survives unchanged. The route is new; the prior approval is not.

Insight four: the 25-power cap attaches to the registrador. For a legal person the ratio is one registrador per 25 powers. Filing capacity is therefore tied directly to the number of authorisations, and a group with several product lines has to size its registradores by powers held, not by number of companies.

Insight five: one power, several directorates, several filings. Article 25 of Anexo I to RA 0001/2026 is easily missed: where the same power authorises an agent to act before several specific directorates, a separate application is required for each. This mirrors the Karplus module activation rule (RA 0007/2025, Anexo I, Article 5 item h) — operating across categories means several powers and several modules.

Insight six: renewal, replacement and revocation form a fifth, separate procedure. The operative parts of RA 0001/2026 list «Renovación, Sustitución o Revocación del Poder» as a category of its own, and item 12 of Anexo I describes replacement or revocation as «un acto opcional del otorgante» — an optional act of the granting party. Changing the legal representative does not take effect automatically; it must go through this procedure.

Insight seven: one concrete amount appears in Article 24 of Anexo I. Where approval of a power has been withdrawn and correction is requested more than five working days later, a fee of C$364.74 (Nicaraguan córdobas) applies. It is the only specific amount verified in the current texts, and it confirms that the fee schedule is denominated in córdobas.

4. Practical recommendations

• Confirm the establishment status of the legal representative first: a natural person needs a basis for establishment in Nicaragua, a legal person must be a domestic entity (definition 39).
• Apostille the power at the place of signature; where apostille is unavailable, use consular legalisation plus legalisation (Chapter 5, Article 8).
• Use the RA 0001/2026 online route for all five categories, but do not assume SAJ approval is no longer needed.
• Size the registrador roster by powers: at most 25 powers each, one registrador per 25 powers for a legal person.
• File separately for each specific directorate covered by a single power (Anexo I, Article 25).
• Route any change of legal representative through the renewal, replacement or revocation procedure rather than assuming the original power lapses or transfers by itself.
• If a withdrawn approval needs correction, file within five working days to avoid the C$364.74 fee (Anexo I, Article 24).

5. Verification checklist

• □ The establishment status of the legal representative has been confirmed (definition 39)
• □ The overseas power has been apostilled at the place of signature, or consularised and legalised
• □ The filing has been made through the RA 0001/2026 online route and SAJ approval obtained (Chapter 6, item 4)
• □ The registrador roster has been checked against the 25-power ceiling
• □ Powers covering several directorates have been filed separately (Anexo I, Article 25)
• □ Any change of legal representative has been prepared under the renewal, replacement or revocation procedure
• □ Any correction of a power has been filed within five working days of the withdrawal of approval (Anexo I, Article 24)

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