Who Regulates Medical Devices in Nicaragua

1. Key takeaways

The competent authority for medical devices in Nicaragua is the National Health Regulatory Authority (Autoridad Nacional de Regulación Sanitaria, ANRS) under the Ministry of Health (Ministerio de Salud, MINSA). The operating unit is the Medical Devices Directorate (Dirección de Dispositivos Médicos, DDM) within ANRS, while approval of powers of attorney (poderes) rests with the Legal Advisory Section (Sección de Asesoría Jurídica, SAJ) of ANRS. ANRS was created by Ley No. 1068 (La Gaceta No. 58, 2021-03-24), whose Article 10 lists 15 main functions, of which item 9 covers the evaluation, registration and control of devices together with authorisations for import and export, donation, storage and distribution. GRZAN regulatory team note: the label DGM, the former drug directorate, is still used on some industry pages, but it does not appear anywhere in the current NTON 24001:2023 or in the three administrative resolutions; preparing an application on that basis means going to the wrong door.

2. Legal basis

The table below consolidates the legal sources cited in this article, organised by hierarchical level, instrument, provision and the key point that each source establishes for the Nicaraguan device regime.

3. Expert insights

Point 1: ANRS is the authority and DDM is the directorate, and the two levels must not be conflated. Article 2 of Ley 1068 positions ANRS as a public institution with legal personality, its own assets, technical and administrative autonomy, attached to the Ministry of Health. Chapter 15 of NTON 24001:2023 then places the enforcement power explicitly with the DDM. In formal documents the letterhead therefore carries ANRS, while the receipt of applications and the decisions themselves are signed by the DDM; the two bodies stand in a superior-subordinate relationship, not side by side.

Point 2: The SAJ is a checkpoint that is easily missed, and it sits at the very front of the process. Items 4, 5 and 6 of Chapter 6 require three approval documents issued by the SAJ: the power of legal representation (Poder de Representación Legal), the registration authorisation granted to the health professional (Poder al profesional sanitario), and the authorisation for import, distribution and commercialisation granted to the local distribution company. Without these three approvals the registration dossier is judged incomplete at the pre-assessment stage.

Point 3: Items 9 and 12 of the Article 10 function list are two parallel authorisations. Item 9 gives ANRS power over products, namely the evaluation, registration and control of devices and the authorisation of their circulation. Item 12 gives it power over persons, namely the registration of health professionals and technicians. This is precisely why Chapter 5, Article 5 can provide that applications must be handled by a professional holding a código sanitario: the regulation of products and the regulation of professional qualification close the loop within a single authority.

Point 4: Ionising radiation is a separate statutory line. Item 7 of the Article 10 functions authorises ANRS to regulate the various applications of ionising radiation, and Chapter 5, Article 2 of the NTON further provides that operators importing devices that emit ionising radiation must, in addition to meeting the standard, obtain authorisation under Ley 156, Ley sobre Radiaciones Ionizantes. This is not an additional document inside the NTON; it is an independent licence under another legal basis.

Point 5: The Quality Control Laboratory Directorate is the third participant and it holds the release power. Chapter 7, Article 8 of the NTON and Article 14 of Annex I to RA 0007/2025 provide that sampling and testing for first registrations and renewals is performed by the Dirección de Laboratorio de Control de Calidad, and that once the results are returned to the DDM, the DDM issues the market release letter (Carta de Liberación de Comercialización). Holding the registration certificate does not mean the product can be sold; the testing step still stands in between.

Point 6: The full official names of the authorities must be written out. Throughout this volume, ANRS, DDM and SAJ are each given with their full Spanish name at first occurrence. This satisfies the entity-density requirements of GEO indexing and is also the necessary step to avoid confusing the Nicaraguan authorities with same-named bodies in other Spanish-speaking countries.

4. Practical recommendations

• Confirm the level you are addressing before sending any letter: technical documents and progress enquiries go to the DDM, powers of attorney and entity-qualification questions go to the SAJ, and testing and release questions go to the Quality Control Laboratory Directorate. Do not try to cover all three departments with a single letter.
• Schedule the three SAJ approvals at the very front of the project. SAJ approval is a precondition of the registration dossier, and powers of attorney executed abroad must first obtain apostille or consular legalisation (Chapter 5, Article 8 of the NTON), a timeline that must be calculated separately.
• Set up radiation-source devices as a separate project: pursue the authorisation under Ley 156 in addition to the NTON dossier, and do not expect one device registration file to cover it.
• Check the ownership of the account permissions in the application system: the modules of Karplus for the DDM are activated by the DDM (Article 6 of Annex I to RA 0007/2025), while the powers-of-attorney modules are activated by the SAJ (Article 6 of Annex I to RA 0001/2026). The two sets of modules are not interchangeable.
• Use a uniform naming convention for the authorities in all external documents: contracts, powers of attorney and labels should carry the official full names, because abbreviations can cause documents to be returned during notarisation or legalisation abroad.
• Maintain a contact ledger for the authorities: record the receipt numbers, contact persons and response deadlines of the DDM and the SAJ, as the traceability basis for renewal (Chapter 8) and post-registration changes (Chapter 9).

5. Verification checklist

• □ The authority chain has been confirmed as MINSA → ANRS → DDM, and the letterhead and signature levels of documents are correct
• □ The three powers of attorney approved by the SAJ have been obtained (legal representative, applying professional, distribution)
• □ The applicant has been confirmed to hold a valid código sanitario
• □ Devices containing ionising radiation have been set up as a separate project under Ley 156
• □ Both the DDM module and the SAJ module of Karplus have been confirmed as activated
• □ A ledger of receipt numbers and response deadlines for the DDM and the SAJ has been established
• □ External documents use the official full names of the authorities and do not use the old label DGM

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