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DINAVISA · Americas

Paraguay medical device regulatory resources

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5 free resources23/25 topics with records2 regulations trackedSep 2026 fees reviewed
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Government registration fees

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Registration timeline

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Medical device regulations

Browse Paraguay's official medical-device instruments — the MSPBS resolution and the DNVS tariff table — with citeable Spanish passages.

Changes after registration

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Common questions about changing a registered medical device in Paraguay. Each question separates published rules from details still awaiting verification.

Structured regulatory requirements

Explore all 80 source-linked facts →

23 of 25 research dimensions currently covered · 23 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified
DINAVISA is an autonomous public-law body related to the Executive through the MSPBS
DINAVISA is a legal person under public law with administrative autonomy, autarquía and its own patrimony, governed by Ley N° 6788/2021 and its regulations, and relates to the Executive bra…
DINAVISA is the competent authority for medical devices
DINAVISA (Dirección Nacional de Vigilancia Sanitaria) is the authority responsible for the regulation, control and inspection of products for health, expressly including medical devices, ex…
2 source-linked facts
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
IVD legal basis: Res. DINAVISA N° 266/2022 plus the PSR of Res. DINAVISA N° 44/2024
Resolution DINAVISA N° 44/2024 establishes the Proceso Simplificado de Registro Sanitario (PSR) for in vitro diagnostic products previously authorised by reference regulatory authorities, o…
MERCOSUR health technical regulations are part of the national legal order
Decreto N° 10403/2012 incorporated into Paraguay's legal order the MERCOSUR Common Market Group resolutions linked to Working Subgroup N° 11 'Health', including the MERCOSUR technical regul…
4 source-linked facts
Checked 2026-09-16
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D03

Device definition & scope

Verified
Definition of a medical device
A medical device is any instrument, apparatus, equipment, implant, software, material or other article intended by the manufacturer to be used, alone or in combination, in human beings for…
Definition of an in-vitro diagnostic product
An in vitro diagnostic product is a reagent, calibrator, control material, specimen receptacle, software, instrument, apparatus or other article, used alone or in combination, intended by t…
2 source-linked facts
Checked 2026-09-16
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D04

Classification rules

Verified
Clases I, II, III y IV — Reglas de Clasificación de Dispositivos Médicos (Resolución DINAVISA N° 226/2024)
Clase I, Clase II, Clase III, Clase IV
1 maintained scheme · 2 related facts
Checked 2026-09-16
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D05

Registration pathways

Verified
Class I: classification declared under oath by the applicant
For class I, the classification is made by sworn declaration filed with the notification, following Annex II of Resolución DINAVISA N° 226/2024; for classes II, III and IV the responsible t…
Classes II-IV: sanitary registration certificate, simplified or integral track
Registration applications for class II, III and IV medical devices (and their accessories), national or imported, are governed by Resolución DINAVISA N° 226/2024, which also governs post ap…
3 source-linked facts
Checked 2026-09-16
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D06

Reliance & recognition

Verified
Annual official list names FDA, EU, PMDA and MFDS but every entry is scoped to medicines or vaccines
statement: The Listado Anual Oficial that Res. 226/2024 Art. 8(a) incorporates by reference does name US FDA, the European Commission (DG SANTE)/EMA, Japan MHLW/PMDA and Korea MFDS — but ev…
Simplified registration route for class II-IV devices authorised by a listed reference authority
statement: A class II, III or IV medical device already authorised by an authority of a country on the Listado Anual Oficial (emitted under Ley N° 7256/2024 Art. 3) or by an authority with…
10 source-linked facts
Checked 2026-09-16
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D07

Economic-operator roles

Verified
A locally registered representative is required to hold the device authorisation
An imported device application requires a power of representation or a distribution and commercialisation authorisation letter from the manufacturer, registered in the Registro Público de P…
Responsible technician declares the class; applicant and technician answer for authenticity
The applicant's responsible technician declares the device class in DINAVISAPy with a technical justification, and the label must carry the name of the legally qualified responsible technic…
3 source-linked facts
Checked 2026-09-16
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D08

Establishment, import & distribution

Verified
Establishment opening, renewal and modification regime replaced earlier DINAVISA resolutions
Resolución DINAVISA N° 226/2025 regulates the procedures for opening, renewal of opening and modification of public and private establishments regulated by DINAVISA, approves process flows…
Manufacturers, importers and distributors need a valid BPFyC/BPAyD certificate
For a production, fractioning, packaging, importing, exporting or distributing establishment of medical devices, sharps and personal protective equipment to operate, it is mandatory to hold…
3 source-linked facts
Checked 2026-09-16
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D09

Dossier requirements

Verified
Foreign documents need consularisation or apostille and translation by a registered public translator
Every legal document of foreign origin must be consularised and legalised, or apostilled, and translated into Spanish by a public translator registered with the Paraguayan Supreme Court of…
Imported device dossier: eight documentary items plus the general conditions
An imported medical device application is built from: (a) evidence of compliance with GMP/BPF in production issued by the competent authority in origin, or an ISO 13485 / CE / UL / FDA / TU…
2 source-linked facts
Checked 2026-09-16
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D10

Official forms & portals

Verified
Applications, class declarations and establishment procedures run through DINAVISAPy
Device applications are built in the Sistema Informático Integrado de Gestión de Registros Sanitarios y de Establecimientos de Salud (DINAVISAPy): the responsible technician declares the de…
1 source-linked fact
Checked 2026-09-16
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Submission & evidence

D11

Label, IFU & language

Verified
Labels must carry the tecnovigilancia adverse-event reporting legend
Every product must include on the label, labelling or in its instructions for use the legend instructing that a suspected incident or adverse event attributable to the medical device be rep…
Instructions for use must be translated into Spanish
The labelling and instructions for use filed with an imported device application must be translated into the Spanish language, and the same requirement appears in the label article as the d…
3 source-linked facts
Checked 2026-09-16
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D12

QMS, audit & inspection

Verified
DINAVISA officials carry out the BPFyC/BPAyD verification inspections
The BPFyC and BPAyD verification inspections of device establishments are carried out by DINAVISA officials, who may enter the establishment even against the owner's refusal; refusal is tre…
1 source-linked fact
Checked 2026-09-16
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D13

Standards, testing & ancillary approvals

Unresolved
DINAVISA device registration dossier — quality and finished-product conformity evidence
Electrical safety
CONATEL homologation — equipment that makes use of the radioelectric spectrum
Wireless / radio
CONATEL homologation — equipment connectable to the public telecommunications network
Telecom terminal
6 maintained overlays · 5 related facts
Checked 2026-09-16
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D14

Fees

Verified
Registro de Familia de Dispositivos médicos, materiales cortopunzantes y equipos de protección individual — Clase I Nacional
PYG 1.170.770
Registro de Familia de Dispositivos médicos — Clase I Importado
PYG 1.756.155
14 maintained fee lines · 2 related facts
Checked 2026-09-16
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D15

Review clocks

Unresolved
Clases II, III y IV — Proceso simplificado de Registro Sanitario · Simplified registration under Resolución DINAVISA N° 226/2024 Art. 8(a): the applicant still files every Art. 6 requirement, but DINAVISA re-examines only items b), c), d), g) and h) of Art. 6 rather than the whole dossier
45 working days
Clases II, III y IV — análisis integral del expediente · Integral registration under Resolución DINAVISA N° 226/2024 Art. 8(b): every Art. 6 item is evaluated
120 working days
Dispositivos ya registrados — modificación Tipo II · Post-registration modification filed in DINAVISAPy; Resolución DINAVISA N° 226/2024 distinguishes Type I from Type II modifications
45 working days
7 maintained pathways · 7 related facts
Checked 2026-09-16
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D16

Approval validity & renewal

Verified
Renewals run as an automatic simplified procedure on a QMS certificate plus a sworn declaration
Renewal of sanitary registration certificates and of class I notifications is processed through simplified automatic renewal procedures; the holder files a BPF/GMP document issued by the co…
Device registrations and class I notifications are valid ten years and renewable
The validity period of both the Notificación Sanitaria Obligatoria and the Certificado de Registro Sanitario for medical devices is ten years, and they may be renewed successively for perio…
4 source-linked facts
Checked 2026-09-16
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Lifecycle & post-market

D17

Change control

Verified
Modifications do not move the registration expiry date
Applications to modify the marketing authorisations of medical devices do not alter the expiry date of the sanitary registration or of the NSO, which stays as originally granted.
Post-registration changes split into immediate-notice (Type I) and prior-authorisation (Type II)
Any modification to characteristic data of a device authorised by DINAVISA must be classified and notified. Type I modifications are of immediate implementation; Type II modifications must…
4 source-linked facts
Checked 2026-09-16
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D18

UDI, listing & traceability

Verified
Implant card required for eight categories of implantable devices
Implantable devices require an implant card (tarjeta de implantación). The resolution lists the categories as cardiac and central circulatory vascular implants, central nervous system impla…
1 source-linked fact
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
Protocol, consent, investigator and site amendments are decided within 15 business days (Res. 238/2024, Art. 18 f)
DINAVISA must authorise or deny requests for amendments to the research protocol and/or informed consent and assent, and additions or changes of investigator and/or research centres, within…
DINAVISA must authorise or refuse a clinical-trial application within 60 business days, or object and stop the clock (Res. 238/2024, Art. 18 b)
Among DINAVISA's responsibilities, Article 18(b) requires it to authorise or deny clinical trial applications within no more than sixty (60) business days, or to object, in which case the p…
8 source-linked facts
Checked 2026-09-16
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D20

Special access & derogation

Verified
Compassionate-use import authorisation for unregistered devices
Resolución DINAVISA N° 203/2025 regulates the import authorisation for medicines and medical devices that have no Paraguayan sanitary registration, for compassionate use, covering products…
DINAVISA-authorised importers may import eligible orphan IVDs for their own use
Resolución DINAVISA N° 266/2022 Art. 16 authorises imports under the figure of 'Productos para Diagnóstico de Uso In vitro importados para uso propio' for users habilitated by DINAVISA as i…
2 source-linked facts
Checked 2026-09-16
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D21

Manufacturer PMS

Verified
Holders must run a documented vigilance system and relay alerts issued abroad
Registration holders must implement and maintain a documented system for collecting and managing reports of adverse events and incidents and safety information generated by their devices, a…
1 source-linked fact
Checked 2026-09-16
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D22

Vigilance & incident reporting

Verified
International alerts concerning the holder's devices within 72 hours
Holders of sanitary registrations must notify DINAVISA within 72 hours of learning of the generation of an international alert reported by the parent company or by a health agency worldwide…
Serious incidents within 24 hours, non-serious within 30 calendar days
A serious adverse event or incident occurring in Paraguay must be reported immediately and within 24 hours of becoming aware of it. Non serious adverse events or incidents occurring in Para…
2 source-linked facts
Checked 2026-09-16
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D23

Recall, FSCA & market surveillance

Verified
DINAVISA may impose any measures needed to minimise device risks
DINAVISA may establish the measures necessary to minimise the risks associated with the use of medical devices so as to maintain an adequate benefit/risk balance, and may base those regulat…
DINAVISA may suspend or cancel a simplified IVD registration and order withdrawal
For IVDs registered through the simplified process, DINAVISA may suspend or cancel the sanitary registration, prohibit commercialisation, distribution, import, export and elaboration, and r…
2 source-linked facts
Checked 2026-09-16
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D24

Advertising, claims & promotion

Verified
DINAVISA regulates and supervises the information and advertising of medical devices (Ley 7361/2024 rewriting Ley 6788/2021 Art. 5 num. 4)
As amended by Ley N° 7361/2024, Article 5 of Ley N° 6788/2021 charges DINAVISA with regulating and supervising the activities of natural and legal persons at every stage including 'informac…
The advertising chapter of Ley 1119/97 (Art. 25) is drafted for especialidades farmacéuticas; device advertising rests on the law's general scope and the implementing decree
Chapter III 'De la promoción y publicidad' of Ley 1119/97 consists of Article 25, whose eleven numbered rules (authority to set criteria, direct to public criteria, message content, ban on…
3 source-linked facts
Checked 2026-09-16
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D25

Submission communications & appeal

Verified
Applications abandoned by operation of law after twelve months of inactivity
Registration applications for medical devices are treated as abandoned and finally closed by operation of law once twelve months have elapsed without the applicant pursuing the process.
Data entered in the resolution's annexes has sworn-declaration status
The data entered in Annexes I, II, III and IV of Resolución DINAVISA N° 226/2024 has the status of a sworn declaration, which is the mechanism by which the applicant's own class declaration…
3 source-linked facts
Checked 2026-09-16
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Government fees

Full fee schedule (14 lines) →

DINAVISA registration fees in PYG · reviewed 2026-09-16

Fee lineAmountProvenance
Registro de Familia de Dispositivos médicos, materiales cortopunzantes y equipos de protección individual — Clase I NacionalPYG 1.170.770Verified
Registro de Familia de Dispositivos médicos — Clase I ImportadoPYG 1.756.155Verified
Registro de Familia de Dispositivos médicos — Clase II NacionalPYG 1.756.155Verified
Registro de Familia de Dispositivos médicos — Clase II ImportadoPYG 2.341.540Verified
10 more fee lines on the full schedule · 14 of 14 rows source-verified

Registration timeline

Full registration timeline →

Dirección Nacional de Vigilancia Sanitaria (DINAVISA), Ministerio de Salud Pública y Bienestar Social (DINAVISA) review clocks and planning ranges · 4-class (I, II, III, IV) — intrinsic-risk classes for devices under Resolución DINAVISA N° 226/2024 Anexo I, and by individual and public-health risk for IVDs under Resolución DINAVISA N° 266/2022 Art. 9 classification

Class / pathwayReview clockPlanning totalProvenance
Clases II, III y IV — Proceso simplificado de Registro Sanitario(Simplified registration under Resolución DINAVISA N° 226/2024 Art. 8(a): the applicant still files every Art. 6 requirement, but DINAVISA re-examines only items b), c), d), g) and h) of Art. 6 rather than the whole dossier)

Art. 9 first paragraph: 'Para el Proceso simplificado de Registro Sanitario, la DINAVISA contará con un plazo de cuarenta y cinco (45) días hábiles para evaluar la documentación establecida en el artículo 8° inciso a) y expedirse al respecto.'

Inconsistencies are notified; the applicant has 60 business days to rectify and a further 30 if new information raises new objections; otherwise the application is refused (Art. 9).

Art. 8's chapeau limits the routing to imported devices ('las solicitudes de inscripción de Dispositivos Médicos importados').

Eligibility rests on a prior authorisation from an authority of a country on the Listado Anual Oficial emitted under Ley N° 7256/2024 Art. 3, but every published entry of that list (Resolución DINAVISA N° 182/2026) states an Alcance of medicamentos and/or vacunas, and no device-scoped entry was found — treat the route as textually available but not evidenced as operative for devices.

45 working days3-6 monthsVerified
Clases II, III y IV — análisis integral del expediente(Integral registration under Resolución DINAVISA N° 226/2024 Art. 8(b): every Art. 6 item is evaluated)

Art. 9 second paragraph: 'Para los productos alcanzados por el artículo 8° inciso b) de la presente Resolución, la DINAVISA contará con un plazo de ciento veinte (120) días hábiles para evaluar la documentación requerida y expedirse al respecto.'

A rectification period follows if objections are raised, and the clock is interrupted while outstanding documentation is delivered.

This is the default route for a class II-IV device that does not hold an authorisation from an authority on the Listado Anual Oficial.

120 working days6-12 monthsVerified
Dispositivos ya registrados — modificación Tipo II(Post-registration modification filed in DINAVISAPy; Resolución DINAVISA N° 226/2024 distinguishes Type I from Type II modifications)

Resolución DINAVISA N° 226/2024 Art. 14 fixes 45 business days for a Type II modification, the type that changes data affecting the device's identity, safety or performance.

Simple data changes are Type I modifications and do not follow this clock.

45 working days3-6 monthsVerified
Productos para diagnóstico de uso in vitro — elaboración nacional y países incluidos en el Anexo I(Registro Sanitario under Resolución DINAVISA N° 266/2022 on the general dossier of Arts. 4 and 5)

Art. 6 first paragraph: 'La DINAVISA se expedirá en un plazo de treinta (30) días hábiles respecto a la solicitud de autorización para la comercialización y uso de los productos de elaboración nacional y países incluidos en el Anexo I.'

The Annex I country list is set by the resolution itself, not by the Listado Anual Oficial used for devices.

30 working days2-4 monthsVerified
3 more pathways on the full timeline · 7 of 7 clocks source-linked
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(45 working days)
  5. 5Registration Approval(1-2 weeks)

Key regulations

All 2 Paraguay regulations →

Official DINAVISA rules and guidance · 2 of 2 documents linked to official sources

Tabla de Aranceles DINAVISA 2026–2027Tabla de Aranceles de la Dirección Nacional de Vigilancia Sanitaria
GeneralVerified
Resolución S.G. N° 554/2024Resolución S.G. N° 554/2024, por la cual se abroga la Resolución S.G. N° 669, de fecha 19 de octubre de 2016, que reglamentaba el Artículo 4° inciso b) de la Ley N° 4659/12
RegistrationVerified
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