Three SAJ Approvals for Powers of Attorney in Nicaragua

1. Key takeaways

The authorisation documents for device registration in Nicaragua are three, and all of them must be approved by the Legal Advisory Section (Sección de Asesoría Jurídica, SAJ) of ANRS under items 4, 5 and 6 of Chapter 6 of NTON 24001:2023: first, the power of attorney for the legal representative granted by the holder to a natural or legal person in the country; second, the applicant power granted to a health professional; and third, the power for import, distribution and commercialisation granted by the holder to a domestic distribution company. RA 0001/2026, issued on 5 February 2026 and effective the same day, moved the processing of the five categories of powers of attorney fully online, eliminated paper submission and repealed RA 0031/2024.

• Three powers of attorney are required, each tied to a different link in the chain: legal representation, filing, and import and distribution.
• All three require prior approval by SAJ; approval is a precondition of filing, not one of the documents filed.
• The granting party is not identical across the three: items 4 and 6 point to the holder, while item 5 allows the holder, the manufacturer’s legal representative or a domestic holder.
• Powers executed abroad need an apostille, or consular legalisation where an apostille is not available.
• Under a maquila arrangement a fourth SAJ-approved document is added: the manufacturing contract or quality agreement under item 11.

2. Legal basis

The provisions below set out the three powers, the responsibility rule they implement and the procedural change introduced by RA 0001/2026. The last row is the one that turns three approvals into four for outsourced manufacture.

3. Expert insights

Insight 1: the granting parties are not the same across the three instruments. For items 4 and 6 the grantor is the holder (Titular); for item 5 it may be the holder, the manufacturer’s legal representative or a domestic holder. That difference determines how many documents a foreign entity must sign, which legalisation chain each follows, and where the Titular identification under item 41 of the Chapter 4 definitions lands in practice.

Insight 2: item 5 carves out the right to file as a separate authorisation to a health professional, and connects with Article 5, sub-item e, of Annex I to RA 0007/2025: registration must be handled by a health sciences professional holding a power approved by SAJ. Without this power, a complete dossier still cannot be filed in Karplus. It is a precondition of filing capacity, not one of the supporting documents.

Insight 3: the legalisation chain is set out in Article 8 of Chapter 5: powers executed abroad require an apostille (apostillado), and where an apostille is not available, consular legalisation with subsequent legalisation (consularizado y legalizado). The same requirement applies to powers from foreign parties under items 4 and 5 of Chapter 6.

Insight 4: a fourth document may sit alongside the three. In a maquila arrangement, item 11 of Chapter 6 requires a manufacturing contract or quality agreement approved by SAJ. Companies using contract manufacture therefore prepare four SAJ-approved documents, each involving a different party.

Insight 5: RA 0001/2026 is the most substantive change to these authorisations in recent years. Issued on 5 February 2026 and effective the same day, it moved the five categories of powers fully online, eliminated paper submission, repealed RA 0031/2024, and set a ceiling of twenty-five powers per registrador together with a ratio of one registrador for every twenty-five powers held by a legal person. The format and the quotas have changed, but the substantive requirement of SAJ approval has been retained.

Insight 6: the parties named in the three powers must match the party information on the application form. Blocks g, i and j of item 2 of Chapter 6 correspond to the holder, the manufacturer’s legal representative and the importer or distributor respectively. A mismatch between the powers and the form is one of the most frequent grounds for rejection at preliminary review.

4. Practical recommendations

• Draw the authorisation chain before signing anything: establish which power is needed between the holder, the legal manufacturer, the domestic legal representative, the registration professional and the distributor.
• Complete the apostille, or the consular legalisation, at the place of execution, rather than waiting until the documents reach Nicaragua.
• Put item 5, the applicant power, at the front of the queue: it is the precondition for filing in Karplus, and nothing can be submitted without it.
• For maquila, prepare four documents, adding the manufacturing contract or quality agreement under item 11, with parties distinct from the first three.
• Follow the online procedure under RA 0001/2026 and check the quotas: a maximum of twenty-five powers per registrador, with one registrador for every twenty-five powers of a legal person.
• Check the parties in the powers word by word against blocks g, i and j of the application form, including the exact form of the name and the identification numbers.

5. Verification checklist

• □ An authorisation chain map has been drawn, showing which power each party needs and in what order they are signed
• □ Powers executed abroad have completed apostille or consular legalisation at the place of execution
• □ The applicant power under item 5 of Chapter 6 has been approved and the right to file in Karplus confirmed
• □ Under maquila, four SAJ-approved documents are being prepared, including item 11 of Chapter 6
• □ Processing follows the online procedure under RA 0001/2026, with the twenty-five power ceiling and registrador ratio checked
• □ The parties in the powers have been reconciled word by word with blocks g, i and j of the application form

Related reading: [CLV: issuing bodies, the two-year default validity and the legalisation chain](/nicaragua-medical-device-registration/certificate-of-free-sale-requirements/) | [The FDA certificate covers US goods only, the CE certificate EU goods only](/nicaragua-medical-device-registration/fda-and-ce-certificate-scope/) | [Legal representative and powers: who bears responsibility in the country](/nicaragua-medical-device-registration/legal-representative-and-powers/)

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