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 DINAVISA’s device page also lists Resolución S.G. N° 554/2024, which repealed Resolución S.G. N° 669/2016, the earlier registration rule.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:
- A company holding an exclusive representation letter from the manufacturer is treated as the representative.
- 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
- Replace any reference to Resolución S.G. 669/2016 with Resolución DINAVISA 226/2024.
- Decide on exclusivity before you sign a representation letter, and issue it directly from the manufacturer.
- Record the power in the Registro Público de Poderes, and note the two-year default validity.
- Check whether your FDA, CE or other authorization qualifies for the simplified route.
- Line up apostilles and Supreme Court–registered translators first.
- Calendar renewal so you file well inside the 120-business-day window before the ten-year expiry.