DINAVISA · Americas

Paraguay medical device regulatory resources

Every Paraguay dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

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

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Government registration fees

Review current DINAVISA application, review, and renewal fees.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Medical device regulations

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

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Government fees

Full fee schedule (14 lines) →

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

Fee line	Amount	Provenance
Registro de Familia de Dispositivos médicos, materiales cortopunzantes y equipos de protección individual — Clase I Nacional	PYG 1.170.770	Verified
Registro de Familia de Dispositivos médicos — Clase I Importado	PYG 1.756.155	Verified
Registro de Familia de Dispositivos médicos — Clase II Nacional	PYG 1.756.155	Verified
Registro de Familia de Dispositivos médicos — Clase II Importado	PYG 2.341.540	Verified

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 / pathway	Review clock	Planning total	Provenance
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	3-6 months	Verified
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	6-12 months	Verified
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	3-6 months	Verified
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)	30 working days	2-4 months	Verified

3 more pathways on the full timeline · 7 of 7 clocks source-linked

1Pre-Submission Preparation(1-3 months)
2Application Submission(1-2 weeks)
3Administrative Review(2-4 weeks)
4Technical Evaluation(45 working days)
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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