Most sponsors who ask me about Nicaragua start with an old rulebook. Distributor decks and consultant summaries still cite Normativa 064, the 2011 device-registration norm. That norm is gone. Nicaragua now registers medical devices under NTON 24001:2023, a mandatory national technical standard, and the filing has moved fully online. If your checklist predates the change, it is asking for the wrong documents.
I am Julio Martinez-Clark, CEO of bioaccess®. This page covers how a device that is already FDA-cleared or CE-marked gets a Registro Sanitario from the Ministry of Health’s Autoridad Nacional de Regulación Sanitaria (ANRS), who holds what, and where sponsors lose time. It sits alongside our LATAM market-access hub, the Nicaragua MINSA country page and the Importer of Record guide. This is operator guidance, not a quote and not legal advice.
One-sentence answer
To sell a medical device in Nicaragua you need a Registro Sanitario from the ANRS Dirección de Dispositivos Médicos under NTON 24001:2023 (Tecnología de la salud. Dispositivos médicos. Requisitos para el Registro Sanitario). A licensed Nicaraguan distributor and a registered health professional file it. It is valid for five years.
The rules that govern the file
Three primary documents matter, and we pulled each one from MINSA’s own site:
- NTON 24001:2023. Chapter 14 expressly repeals Normativa 064 (Acuerdo Ministerial 144-2011), two 2016 circulars on dossiers and samples, and, for device registration, Resolución Administrativa 003/2021. Under Chapter 16, the standard takes effect ninety days after publication in La Gaceta.
- ANRS Circular ANRS-DDM-BRML-0002-06-2026 (5 June 2026). It opened a public consultation on an update to NTON 24001 that ran until 1 July 2026. So a revision is coming. Before you lock your dossier, check whether the updated text has been published.
Who holds what: the titular, the representative and the distributor
This is where Nicaragua differs from what many sponsors expect. NTON 24001 defines the titular del registro sanitario as the entity that grants distribution, registration and legal-representation authorizations to the person or company designated in the country. In other words, the product owner sits at the top of the chain, and Nicaraguan companies act under powers that the owner grants.
The dossier reflects that. Chapter 6 asks for:
- the distributor’s current ANRS Licencia Sanitaria;
- a power of legal representation from the titular to its representative in Nicaragua;
- a power from the titular (or its legal representative in Nicaragua) to the health professional who files;
- a power or authorization from the titular to the Nicaraguan distributor to import, distribute and sell.
The ANRS legal section (Sección de Asesoría Jurídica) has to approve each of these powers before the filing. Under general provision 8, foreign powers must be apostilled, or consularized and legalized.
Chapter 9 also lists “change or addition of distributor” as a post-registration change, filed with a distribution letter from the titular. The preevaluation record in Annex A has a field for the authorized distributor or distributors. So under the standard’s own wording, distributors are something the titular authorizes. They are not the owner of the file.
Who can file
General provision 5 limits the people who handle registration to health-science or electromedicine professionals holding an ANRS código sanitario. The manufacturer has to accredit them by letter or by a power approved by the Dirección de Dispositivos Médicos.
What goes in the dossier
Chapter 6 of NTON 24001 sets the core list:
- The official application form, with device data and the details of the manufacturer, titular, legal representative, distributor and registrar.
- A Certificate of Free Sale from the competent authority of the country of manufacture, or from a PAHO/WHO regional reference authority. If the certificate states no expiry, it is treated as valid for two years. An FDA certificate is mandatory only for products made in the United States.
- An ISO 13485 certificate or an equivalent ISO product certificate.
- A CE certificate, mandatory for EU manufacturers.
- An electrical-safety certificate (IEC, UL, CSA or equivalent) for powered equipment.
- A product monograph: technical specifications; a clinical evaluation (mandatory for risk classes III and IV, and considered case by case for class II); biocompatibility; analytical protocol; stability; sterilization method and validation; disposal method; a tecnovigilancia program naming the responsible person in Nicaragua; labels; and the IFU.
- A commercial sample with at least 80% of shelf life remaining. Hospital equipment and IVDs with special storage needs are exempt.
Two reliance points save real work. First, biocompatibility studies are waived for products made and sold in countries with reference regulatory authorities. Second, a manufacturer holding an ISO 13485 certificate from an MDSAP-recognized certification body is exempt from several monograph items.
Under general provision 3, the ANRS sets the risk class (I to IV, per Annex B) itself, regardless of how another country classified the device. Do not assume your US or EU class carries over.
The ANRS can ask for physical originals at any stage. Neither document sets a statutory end-to-end day count, so I will not publish one. We confirm the timeline at proposal.
After approval: the first-import check
For new registrations of products on the ANRS market-surveillance list, NTON 24001 Chapter 7 requires the registrar to report the first import and request quality-control analysis. The goods stay on hold until the result comes back. A nonconforming lot means a new lot within 90 days, and a second failure cancels the registration. Chapter 10 also cancels a new registration if no first import for analysis happens during its validity. Plan the first shipment as part of the registration project, not as a separate logistics task.
Each product gets a unique, permanent registration number. Devices that qualify as a family under Annex C share one number. Validity is five years (Chapter 11). Model, site, software and label changes follow the Chapter 9 routes. A change of manufacturer, brand, trade name or material requires a new registration.
What this file is not
- It is not a clinical-trial authorization. Study approvals follow a separate track; see our Nicaragua clinical trials page.
- It does not cover radio homologation. Wireless devices go through Nicaragua’s telecom regulator separately, and devices that emit ionizing radiation also need authorization under Ley 156.
- It is not part of the bioaccess® fixed-price market-access subscription. Nicaragua is quoted as scoped, manufacturer-funded processing.
How bioaccess® runs Nicaragua registrations
bioaccess® processes Nicaragua registrations funded by the manufacturer. That covers the dossier, certified Spanish translations, legal-section approval of the powers, filing through a coded registrar, agency liaison, the first-import analysis, and tecnovigilancia. Local counsel reviews your distribution agreement so that the powers you grant match the control you intend to keep. ANRS fees are set by the regulator, and we confirm scope and pricing at proposal. Details: bioaccessla.com/market-access/nicaragua-minsa.
Operator checklist
- Throw out any checklist that still cites Normativa 064. File under NTON 24001:2023, and check whether the 2026 update has been published.
- Pick a distributor with a current ANRS Licencia Sanitaria and a coded registrar.
- Draft the three powers (representation, registration, distribution) together, apostille them, and budget time for the legal section to approve them.
- Use the reference-authority and MDSAP exemptions to trim the monograph.
- Plan the first import and its quality-control analysis before approval.