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When a manufacturer asks me how to register a device in Paraguay, I start with the paper that decides who controls the registration: the manufacturer’s letter of representation. Under the current DINAVISA rule, that letter decides which Paraguayan company the agency treats as your representative. If you sign the wrong letter, you can find out later that someone else’s file comes first.

I am Julio Martinez-Clark, CEO of bioaccess®. This page explains how to get a device that is already FDA-cleared or CE-marked onto the Paraguayan market through the Dirección Nacional de Vigilancia Sanitaria (DINAVISA). It sits alongside our LATAM market-access hub, the Paraguay DINAVISA country page and the Importer of Record guide. If you are running a first-in-human study rather than launching, read trial authorization vs registro first. This is operator guidance, not a quote and not legal advice.

One-sentence answer

Paraguay authorizes medical devices under Resolución DINAVISA N° 226/2024, in force since 16 September 2024. Class I devices get a Notificación Sanitaria Obligatoria (NSO). Classes II, III and IV need a Registro Sanitario. Imported devices already authorized in a country on DINAVISA’s official list qualify for a simplified review with a 45-business-day evaluation clock. Both the NSO and the registration last ten years.

The rule that governs the file

Resolución 226/2024 (signed in Asunción in August 2024) sets the requirements for marketing authorization, post-authorization changes and renewals. Article 36 put it in force on 16 September 2024. DINAVISA’s device page also lists Resolución S.G. N° 554/2024, which repealed Resolución S.G. N° 669/2016, the earlier registration rule. If your SOP, distributor contract or consultant memo still cites 669/2016 or its annexes, update it. Under Article 34, certificates issued under the old rule stay valid until they expire. After that, renewal follows Resolución 226.

Filing is electronic, through DINAVISA’s integrated registration system, DINAVISAPy.

Classification is declared, then accepted or rejected

Annex I of Resolución 226 sets four risk classes. Under Article 4, the applicant’s technical responsible person declares the class in DINAVISAPy and attaches a technical justification. DINAVISA then accepts or rejects that class for Class II, III and IV devices. A rejection has to be technically reasoned, and the application is closed, so you start again with a new filing and fee.

Class I devices are classified by sworn declaration (Annex II) and authorized through an NSO. Under Article 7, the NSO allows automatic manufacture or import. Article 7 also says that a wrong Class I declaration voids the NSO, and the class cannot be changed once the NSO issues. Classify carefully. A Class II device filed as Class I can cost you the whole file.

What an imported device has to file

Article 6 lists the requirements for imported products:

• (a) Quality-system evidence: the GMP certificate from the authority of origin, or ISO 13485, CE, UL, FDA, TÜV, MDSAP or an equivalent certificate.
• (b) A power of representation or a letter authorizing distribution and sale from the manufacturer, recorded in Paraguay’s Registro Público de Poderes. It is valid for two years when it states no validity.
• (c) Contracts for any outsourced manufacturing.
• (d) A certificate of free sale, proof of registration, or an equivalent document from the authority where the device is made or sold. It is also valid for two years when it states no validity.
• (e) A quality-control certificate for the finished product, or a Notified Body certificate of conformity.
• (f) Stability studies, where applicable.
• (g) Labels and instructions for use translated into Spanish.
• (h) A radiation-protection license from the national radiological authority, for devices that emit radiation.

Two translation rules catch many sponsors. Every foreign legal document has to be consularized and legalized, or apostilled, and then translated into Spanish by a public translator registered with Paraguay’s Supreme Court. Every foreign technical document also needs a translation by that kind of translator. Start these translations early, because they usually take the longest.

The representation rule

Article 6(b) covers the case where two or more companies present themselves as representatives of the same manufacturer. DINAVISA applies a tie-break:

1. A company holding an exclusive representation letter from the manufacturer is treated as the representative.
2. Without exclusivity, the company holding a letter issued directly by the manufacturer wins. Companies presenting letters issued by distributors are left out.

The letter must name the legal manufacturer and the importing applicant, with full addresses, and expressly authorize the applicant to represent and/or distribute and sell in Paraguay. If the manufacturer withdraws representation, the titular must notify DINAVISA immediately.

In practice, Paraguay comes down to a contract decision. The registration follows the company DINAVISA treats as your representative, and the letter you sign decides who that is. Hand an exclusive letter to a distributor that funds the filing, and you have chosen your Paraguayan channel for the life of the registration. Our country page explains how we structure that relationship so you keep control.

Simplified review or integral review

Article 8 sorts Class II to IV imports into two routes:

• Simplified registration. This applies when the device is authorized by an authority on DINAVISA’s Listado Anual Oficial (Resolución DINAVISA N° 148/2024 and its updates), or by a regulator with a published bilateral recognition agreement. You still file every Article 6 item, but DINAVISA evaluates only items (b), (c), (d), (g) and (h): representation, outsourcing, free sale, Spanish labeling and the radiation license. That holds only if the device’s conditions match what the regulator of origin authorized. Article 9 gives DINAVISA 45 business days to rule.
• Integral analysis. Everything else is reviewed against all Article 6 items. Article 9 sets a separate clock for this route, but the scanned copy on DINAVISA’s site loses that sentence at a page break, so confirm the current figure with the agency rather than relying on a secondhand number.

On either route, deficiencies must be fixed within 60 business days of notice. If the response raises new issues, you get 30 more business days. If observations are not resolved in time, the application is denied.

Labels, changes and renewal

• Labels (Article 19). Label content must be in Spanish, and a complementary Spanish label is allowed. The label must show the manufacturer, the importer and distributor where applicable, the technical responsible person, the authorized sale condition, and the legend “AUTORIZADO POR DINAVISA” with the registration or NSO number.
• Changes (Articles 13–14). Type I changes are notified and can be implemented immediately. Type II changes need DINAVISA approval first, with a 45-business-day evaluation.
• Testing (Article 29). DINAVISA can order samples and tests at the titular’s cost.
• Validity and renewal (Articles 10–12). Registrations and NSOs last ten years. Renewal is a simplified automatic process, but you must file within the 120 business days before expiry. Miss that window and you file a new registration.

What this file is not

• It is not a clinical-trial authorization. FIH study approval runs on a different track; see our Paraguay CRO page.
• It is not part of the bioaccess® fixed-price market-access subscription. Paraguay is quoted as scoped, manufacturer-funded processing.

How bioaccess® runs Paraguay registrations

bioaccess® processes DINAVISA registrations funded by the manufacturer. That covers classification justification, the Article 6 dossier, sworn-translator coordination, the DINAVISAPy filing, agency liaison and tecnovigilancia. Local counsel reviews your representation letter and distribution agreement so that control stays where you intend it. DINAVISA sets its own fees (Article 35), and we confirm scope and pricing at proposal. Details: bioaccessla.com/market-access/paraguay-dinavisa.

Operator checklist

1. Replace any reference to Resolución S.G. 669/2016 with Resolución DINAVISA 226/2024.
2. Decide on exclusivity before you sign a representation letter, and issue it directly from the manufacturer.
3. Record the power in the Registro Público de Poderes, and note the two-year default validity.
4. Check whether your FDA, CE or other authorization qualifies for the simplified route.
5. Line up apostilles and Supreme Court–registered translators first.
6. Calendar renewal so you file well inside the 120-business-day window before the ten-year expiry.

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

1. Throw out any checklist that still cites Normativa 064. File under NTON 24001:2023, and check whether the 2026 update has been published.
2. Pick a distributor with a current ANRS Licencia Sanitaria and a coded registrar.
3. Draft the three powers (representation, registration, distribution) together, apostille them, and budget time for the legal section to approve them.
4. Use the reference-authority and MDSAP exemptions to trim the monograph.
5. Plan the first import and its quality-control analysis before approval.