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DINAVISA · structured requirements

🇵🇾 Paraguay medical device regulatory data

Explore the medical device requirements currently available for Paraguay, organized by topic and linked to official sources.

80 facts25 dimensions17 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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DINAVISA regulates and supervises the information and advertising of medical devices (Ley 7361/2024 rewriting Ley 6788/2021 Art. 5 num. 4)

advertising.dinavisa-regulates-device-advertising-ley-7361
Fact-level verified

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 'información y publicidad' of health products, expressly listing medicines, drugs, chemical products, reagents, medical devices and every other product for use in human medicine.

Conditions
  • Ley 7361/2024 was promulgated on 31 October 2024.

Effective from 2024-10-31

English gist: DINAVISA's statutory functions include regulating and supervising information and advertising of health products, with medical devices and reagents named explicitly.

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

advertising.ley-1119-chapter-iii-drafted-for-pharmaceutical-specialties
Fact-level verified

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 gifts, professional information, prohibition of advertising unregistered products) are all expressed in terms of especialidades farmacéuticas and medicamentos. The law's Article 1 nonetheless places 'publicidad' of every product within its scope, including reagents and 'todo otro producto de uso y aplicación en medicina humana'.

Conditions
  • No DINAVISA resolution specific to medical-device advertising was located; Resolución DINAVISA 286/2023 covers automatic authorisation of advertising for medicines, phytotherapeutics, homeopathics and dietary supplements only.

English gist: the statutory advertising chapter targets pharmaceutical specialties (authority sets criteria; advertising of unregistered medicines is banned nationwide). Recorded to make explicit that the device advertising regime is derived from Art. 1 scope + Decreto 764/2003 + Ley 7361/2024, not from Art. 25 itself.

DINAVISA may suspend the advertising of products and establishments as a precautionary measure where there is a serious imminent health risk (Ley 7361/2024, new Art. 27 e)

advertising.precautionary-suspension-of-advertising
Fact-level verified

Article 27 of Ley 6788/2021, as rewritten by Ley 7361/2024, allows DINAVISA, without further formality, to adopt precautionary measures when a serious and imminent health risk exists or is reasonably suspected; the list includes quarantine, market withdrawal, prohibition of use, suspension of establishment activities, suspension of advertising of establishments and products, and provisional closure.

Conditions
  • Trigger: an existing or reasonably suspected serious and imminent risk to health.

Effective from 2024-10-31

English gist: among DINAVISA's precautionary powers is suspension of advertising of establishments and products under its competence.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Renewals run as an automatic simplified procedure on a QMS certificate plus a sworn declaration

validity.automatic-simplified-renewal
Fact-level verified

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 competent authority or an ISO 13485 / CE / UL / FDA / TUV / MDSAP or equivalent certificate, together with a sworn declaration about modifications.

Conditions
  • Applies to certificates of sanitary registration and to the NSO.
  • The QMS certificate accepted at renewal is the same family of certificates accepted at initial registration under Art. 6(a).

Effective from 2024-09-16

Source language: Spanish. Translation: 'To determine that the renewal of Sanitary Registration Certificates and of the NSO shall be processed through simplified automatic renewal procedures' — the article then lists the documents, beginning with the BPF/GMP or ISO 13485 / CE / UL / FDA / TUV / MDSAP certificate and a sworn declaration of modifications.

Device registrations and class I notifications are valid ten years and renewable

validity.device-registration-ten-years
Fact-level verified

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 periods of equal duration.

Conditions
  • Applies to all device classes.
  • Renewal must be applied for within the 120 business days before expiry (Art. 11), otherwise the file is refused and a new registration procedure is required.

Effective from 2024-09-16

Source language: Spanish. Translation: 'To establish that the validity period of the Mandatory Sanitary Notification and of the Sanitary Registration Certificate for medical devices shall be ten (10) years, and may be renewed successively for periods of equal duration.'

IVD registrations are valid five years and renewable for equal periods

validity.ivd-registration-five-years
Fact-level verified

The sanitary registration of an in-vitro diagnostic product is valid for five years from issue and may be renewed for an equal period.

Conditions
  • Applies to IVD sanitary registrations under Resolución DINAVISA N° 266/2022.
  • Shorter than the ten-year validity that Res. 226/2024 gives medical devices.

Source language: Spanish. Translation: 'The Sanitary Registration of In Vitro Diagnostic Products shall be valid for five (5) years from its issue, and may be renewed for an equal period.'

Renewal must be filed within the 120 business days before expiry

validity.renewal-window-120-business-days
Fact-level verified

The product holder must file the renewal application within the 120 business days preceding the expiry date; otherwise the procedure is refused and the applicant must start a new product registration procedure.

Conditions
  • Applies to both the certificate of sanitary registration and the notification (NSO).
  • Missing the window means a fresh registration, not a late renewal.

Effective from 2024-09-16

Source language: Spanish. Translation: 'the holder of the product must file the application within the one hundred and twenty (120) business days prior to its expiry date, failing which the procedure shall be refused and the applicant must start a new product registration procedure.'

Authority & regime

Which authority and binding regime govern this product, task, and date?

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DINAVISA is an autonomous public-law body related to the Executive through the MSPBS

authority.dinavisa-autonomous-public-law-body
Fact-level verified

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 branch through the MSPBS. It has full legal capacity to act in the public and private sphere throughout Paraguay.

Conditions
  • Ley N° 6788/2021 was later modified by Ley N° 7361/2024, which extended DINAVISA's remit to food; Res. DINAVISA N° 182/2026 recites the amended Art. 3.

Source language: Spanish. Translation: 'The National Sanitary Surveillance Directorate (DINAVISA), established in Article 1 of this Law, is constituted as a legal person under public law, with administrative autonomy, autarquía and its own patrimony. It shall be governed by the provisions of this Law, the complementary norms and their regulations. It shall relate to the Executive Branch through the Ministry of Public Health and Social Welfare.' and 'DINAVISA shall have full legal capacity to act in the public and private sphere throughout the territory of the Republic of Paraguay.'

DINAVISA is the competent authority for medical devices

authority.dinavisa-competent-authority
Fact-level verified

DINAVISA (Dirección Nacional de Vigilancia Sanitaria) is the authority responsible for the regulation, control and inspection of products for health, expressly including medical devices, executing the public policies designed by the Ministerio de Salud Pública y Bienestar Social (MSPBS), which acts as rector ministry. It may sanction the infringements it detects.

Conditions
  • Expressly covers medicamentos de uso humano, drogas, productos químicos, reactivos, dispositivos médicos and any other product for human medical use or application, as well as cosmetics, perfumes and domisanitarios.
  • MSPBS is the rector ministry, not the device authority.

Source language: Spanish. Translation: 'The National Sanitary Surveillance Directorate (DINAVISA) shall be considered the responsible authority as regards the provisions relating to its field of competence, through the execution of the public policies designed by the Ministry of Public Health and Social Welfare, in its capacity as rector in the matter, the development of adequate strategies, the regulation, control and inspection of products for health such as medicines for human use, drugs, chemical products, reagents, medical devices and any other product for use and application in human medicine, as well as products considered cosmetics, perfumes, domisanitarios and similar, and those products whose regulation and control are assigned to it by law, as well as assuring their quality, safety and efficacy, and it may sanction the infringements detected.' This is the fact that the jurisdiction's regulator display label should align to.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Modifications do not move the registration expiry date

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Fact-level verified

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.

Conditions
  • Applies to all modifications under the resolution, including Type II.

Effective from 2024-09-16

Source language: Spanish. Translation: 'Applications to modify the marketing authorisations of medical devices provided for in this Resolution shall not imply the modification of the expiry date of the sanitary registration or of the NSO, which shall remain unchanged until its original validity.'

Post-registration changes split into immediate-notice (Type I) and prior-authorisation (Type II)

change.two-types-of-post-registration-modification
Fact-level verified

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 be authorised by DINAVISA before implementation. The corresponding fee must be paid for each modification and an Annex III sworn declaration is filed.

Conditions
  • Applies to devices with a sanitary registration or NSO.
  • A modification does not change the expiry date of the registration or NSO (Art. 16).

Effective from 2024-09-16

Source language: Spanish. Translation: 'Any modification made to some of the characteristic data of a medical device authorised by DINAVISA ... must be classified and notified ... TYPE 1) NOTIFICATION OF MODIFICATIONS OF IMMEDIATE IMPLEMENTATION ... TYPE II) NOTIFICATION OF MODIFICATIONS OF DEFERRED IMPLEMENTATION: They must be authorised by DINAVISA for their subsequent implementation.' plus 'Pay the corresponding fee for each modification'.

Type II modification decisions: 45 business days, with 60 business days to answer objections

change.type-ii-authorisation-clock-and-rectification
Fact-level verified

DINAVISA has 45 business days to evaluate the documentation required for Type II modifications and decide; inconsistencies are notified to the applicant, who has 60 business days from the first business day after notification to rectify. If the response introduces new information that raises further inconsistencies, the applicant has a further 30 business days. If the observations are not rectified in time or the technical evaluation is unsatisfactory, implementation of the modification is refused.

Conditions
  • Applies to Type II (deferred-implementation) modifications of authorised devices.
  • A fee is payable per modification.

Effective from 2024-09-16

Source language: Spanish. Translation: 'To establish that DINAVISA shall have a term of forty-five (45) business days to evaluate the documentation required for TYPE II modifications and decide thereon.' The rectification periods are stated in the same article; the 45-business-day figure is quoted verbatim here and the rectification periods are described.

Undeclared modifications trigger ex officio suspension of the marketing authorisation

change.undeclared-modification-suspension
Fact-level verified

Where post-registration or post-notification modifications are detected that were not declared, DINAVISA proceeds ex officio to suspend the marketing authorisation until the position is regularised.

Conditions
  • Applies to devices with a sanitary registration or NSO.
  • Suspension lasts until the corresponding regularisation.

Effective from 2024-09-16

Source language: Spanish. Translation: 'In the event that undeclared post-registration/NSO modifications are detected, the marketing authorisation shall be suspended ex officio until the corresponding regularisation.'

Classification rules

What local class follows from which rules and decisive product facts?

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Four device classes; classification rules in Annex I, declared by the applicant and validated by DINAVISA

classification.four-classes-and-dinavisa-acceptance
Fact-level verified

Resolución DINAVISA N° 226/2024 approves the Medical Device Classification Rules in Annex I, which may be updated according to internationally recognised provisions and taking account of technological progress and adverse-event information. The applicant's responsible technician declares the class in DINAVISAPy with a technical justification, DINAVISA may accept or reject classes II, III and IV, and class I is classified under sworn declaration following Annex II.

Conditions
  • Applies to all device classes.
  • The declared class of a notified class I device may not be modified after the NSO is issued.

Effective from 2024-09-16

Source language: Spanish. Translation of Art. 3: 'To approve the Medical Device Classification Rules, in accordance with ANNEX I which forms part of this Resolution, and to provide that they may be updated in accordance with internationally recognised provisions in the field, considering technological progress and information on adverse events occurring with the use or application of medical devices.'

IVDs are classified in four risk classes

classification.ivd-four-risk-classes
Fact-level verified

In-vitro diagnostic products are classified by individual risk and public-health risk: class I low individual and low public-health risk; class II medium; class III high individual and/or medium public-health risk; class IV high individual and high public-health risk. Annex III of the resolution contains the international classification rules.

Conditions
  • Class IV is the class to which the simplified PSR route of Res. DINAVISA N° 44/2024 applies.
  • Annex III governs classification.

Source language: Spanish. Translation: 'Class I: Products with low risk for individual health and low risk for public health; Class II: ... medium risk ...; Class III: ... high risk for individual health and/or medium risk for public health; and Class IV: Products with high risk for individual health and high risk for public health.' Art. 10 approves the international classification rules in Annex III.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Protocol, consent, investigator and site amendments are decided within 15 business days (Res. 238/2024, Art. 18 f)

clinical.amendment-decision-fifteen-business-days
Fact-level verified

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 no more than fifteen (15) business days, or object, in which case the period is suspended by the evaluation report.

Conditions
  • Business days.
  • Substantial amendments need DINAVISA authorisation before implementation (Art. 34 h).

English gist: amendment requests (protocol, consent/assent, investigators, sites) are authorised or denied within 15 business days, or objected to with the clock suspended.

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)

clinical.authorisation-decision-sixty-business-days
Fact-level verified

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 period is suspended by the issue of the evaluation report. Under Article 18(a) an application is treated as withdrawn if the sponsor does not answer.

Conditions
  • Business days (días hábiles).
  • The clock is suspended when DINAVISA issues an evaluation report with objections.

English gist: DINAVISA evaluates the application and issues an evaluation report (no sponsor reply = application deemed withdrawn), and must authorise or refuse within 60 business days or object, suspending the clock with the evaluation report.

Clinical trials of medical devices and IVDs with a registration purpose must be authorised by DINAVISA before they start (Res. 238/2024, Art. 3)

clinical.dinavisa-prior-authorisation-device-and-ivd-trials
Fact-level verified

Resolución DINAVISA N° 238/2024 brings within its scope, and subjects to prior authorisation by DINAVISA, clinical trials for medicines, vaccines, medical devices and in-vitro diagnostic products conducted with a registration purpose in Paraguay, as well as trials on already-registered products studying new indications, routes, concentrations, dosage forms, posologies, combinations or any post-registration change requiring registrable clinical data.

Conditions
  • Applies to trials in human beings within the national territory (Art. 2).
  • The resolution abrogates Resolución DINAVISA N° 323 of 17 July 2023.

English gist: Article 3 lists the trials within scope that must be authorised in advance by DINAVISA: (a) trials of medicines, vaccines, medical devices and IVDs with a registration purpose in Paraguay; (b) trials on products registered with national regulators that study a new indication, route, concentration, dosage form, posology, combination or any post-registration change needing registrable clinical data. Text transcribed from the scanned official PDF (OCR checked against the page image).

Ethics committees reviewing device or IVD trials need DINAVISA's complementary accreditation in addition to the MSPBS basic accreditation (Res. 238/2024, Art. 4 num. 1)

clinical.ethics-committee-complementary-accreditation-by-dinavisa
Fact-level verified

The basic accreditation of a research ethics committee (CEIS) is granted by the Ministry of Health and suffices for committees that do not review clinical trials of medicines, vaccines, devices or IVDs; committees that review such trials also need a complementary accreditation granted by DINAVISA and must follow Good Clinical Practice. DINAVISA keeps an updated list of complementary-accredited CEIS on its website (Art. 18 g).

Conditions
  • Applies to CEIS reviewing trials within the scope of the resolution.

English gist: two-tier CEIS accreditation; the DINAVISA complementary accreditation is mandatory for committees that review device/IVD clinical trials.

The sponsor must file an ICH E3 clinical study report within 12 months of the end of the trial (Res. 056/2026, Art. 3)

clinical.global-study-report-within-twelve-months
Fact-level verified

In addition to the final reports required by Resolución 238/2024, the sponsor or its legal representative in Paraguay must submit to DINAVISA the global study reports within no more than twelve (12) months from the end of the clinical trial, structured according to the ICH E3 Clinical Study Reports guideline; non-compliance is sanctionable.

Conditions
  • Counted from the end of the clinical trial.
  • In force from 16 February 2026.

Effective from 2026-02-16

English gist: global clinical study reports in ICH E3 format are due within 12 months of trial completion, on top of the final reports under Res. 238/2024; breach is sanctionable.

The investigator's brochure must follow ICH E6(R3); non-compliance is a ground for rejecting the trial application (Res. 056/2026, Art. 2)

clinical.investigator-brochure-ich-e6r3-required
Fact-level verified

Resolución DINAVISA N° 056/2026 supplements Resolución 238/2024: the information requested in the Investigator's Manual must comply with the ICH E6(R3) Good Clinical Practice guideline, including its documentary requirements, and failure to comply is a ground for rejection of the clinical-trial authorisation application.

Conditions
  • In force from the date of signature, 16 February 2026 (Art. 4).
  • Annexed to Resolución 238/2024 (Art. 5).

Effective from 2026-02-16

English gist: the investigator's brochure must meet ICH E6(R3) GCP, including document requirements; non-compliance causes rejection of the trial application.

The sponsor must answer DINAVISA objections within 30 business days and obtain authorisation before starting (Res. 238/2024, Art. 34 g–i)

clinical.sponsor-reply-to-objections-thirty-business-days
Fact-level verified

Article 34 lists the sponsor's general responsibilities: to request DINAVISA authorisation of the trial before it starts, to request authorisation of substantial amendments before implementing them, and to respond to DINAVISA's objections within no more than thirty (30) business days.

Conditions
  • Business days.

English gist: sponsor must seek DINAVISA authorisation before the trial starts, seek authorisation of substantial amendments before executing them, and reply to DINAVISA objections within 30 business days.

Ley 1119/97 Art. 30 requires prior authorisation of all clinical trials by the national health authority, under GCP and the Declaration of Helsinki

clinical.statutory-prior-authorisation-and-helsinki
Fact-level verified

Article 30 of Ley N° 1119/97 requires all clinical trials to be previously authorised by the national health authority under conditions regulated in line with Good Clinical Practice, to respect fundamental rights and the ethical postulates of the Declaration of Helsinki, allows the authority to restrict complex trials to designated hospitals or research centres, and empowers it to order the precautionary interruption of a trial.

Conditions
  • The law's own definition of 'ensayos clínicos' (Art. 5) is drafted around substances or medicines; the device- and IVD-specific implementation is Resolución DINAVISA 238/2024, which cites this article as its legal basis.

English gist: all clinical trials need prior authorisation by the national health authority under GCP-aligned regulation; Helsinki ethics apply; complex trials may be limited to designated centres; the authority may order precautionary interruption.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Definition of a medical device

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Fact-level verified

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 the specified medical purposes listed in the resolution, whose principal intended action in or on the human body is not achieved by pharmacological, immunological or metabolic means, although such means may contribute to its intended action. The listed purposes open with diagnosis, prevention, monitoring, treatment or alleviation of disease.

Conditions
  • Definition adopted by Resolución DINAVISA N° 226/2024 Art. 2.4 for the device registration regime.
  • The definition enumerates purposes (a) onwards; the excerpt covers purpose (a).

Effective from 2024-09-16

Source language: Spanish. Translation: 'Medical device: Any instrument, apparatus, equipment, implant, computer program (software), materials or other articles, intended by the manufacturer to be used, alone or in combination, in human beings for any of the specific medical purposes mentioned below, and whose principal intended action is not achieved by pharmacological, immunological or metabolic means in the human body, but which such means may contribute to its intended action: a. To carry out diagnosis, prevention, monitoring, treatment or alleviation of a disease; ...'

Definition of an in-vitro diagnostic product

scope.ivd-definition
Fact-level verified

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 the manufacturer for the in-vitro examination of specimens derived from the human body, solely or principally, to provide information for diagnostic, aid-to-diagnosis, detection, monitoring, predisposition, prognosis, prediction, determination of physiological state or compatibility purposes.

Conditions
  • Definition adopted by Resolución DINAVISA N° 266/2022 Art. 2.18; Res. DINAVISA N° 44/2024 Art. 2 borrows it for the PSR.

Source language: Spanish. Translation: 'In vitro diagnostic product: Reagents, calibrators, control materials, specimen collectors, computer programs (software), instruments, apparatus and other articles, used individually or in combination, with the purpose of use determined by the manufacturer for the in vitro examination of specimens derived from the human body, solely or principally, to provide information for diagnostic purposes, aid to diagnosis, detection, monitoring, predisposition, prognosis, prediction, determination of physiological state or compatibility.'

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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Foreign documents need consularisation or apostille and translation by a registered public translator

dossier.consularisation-and-sworn-translation
Fact-level verified

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 Justice. Every technical document of foreign origin must likewise be translated into Spanish by a public translator registered with the Supreme Court.

Conditions
  • Applies to all device classes, including class I notifications.
  • All documents of Art. 6 must be in force when the certificate or NSO is issued.

Effective from 2024-09-16

Source language: Spanish. Translation: 'All legal documents of foreign origin must be consularised and legalised, or apostilled, and translated into the Spanish language by a public translator registered with the Supreme Court of Justice. All technical documents of foreign origin must be translated into the Spanish language by a public translator registered with the Supreme Court of Justice.'

Imported device dossier: eight documentary items plus the general conditions

dossier.imported-device-document-set
Fact-level verified

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 / TUV / MDSAP or equivalent certificate from a certification body; (b) the manufacturer's power of representation or distribution authorisation letter registered in the Registro Público de Poderes; (c) the third-party manufacturing contract where part or all of production is outsourced; (d) the free-sale certificate or sanitary-registration certificate or equivalent from the competent authority of the country of manufacture and/or commercialisation; (e) the finished-product quality-control certificate covering functionality, quality and safety tests, or a product conformity certificate issued by a Notified Body; (f) stability studies; (g) label and instructions for use translated into Spanish; and (h) the ARRN radiation licence where applicable.

Conditions
  • All documents must be in force at the time the registration certificate or NSO is issued.
  • Where a specific technical regulation requires complementary information, it is added to the label or instructions for use.
  • For national products the QMS item is a BPF/GMP document issued by DINAVISA or an ISO 13485 or equivalent certificate (Art. 6 national-product limb).

Effective from 2024-09-16

Source language: Spanish. Translation of literal (a): 'Documentation credibly evidencing compliance with the quality standards in the production processes BPF / GMP granted by the competent Sanitary Authority in origin or ISO 13485 / CE / UL / FDA / TUV / MDSAP certificate or another equivalent certificate granted by a certifying entity.' Literal (e): 'Quality-control certificate of the finished product with all tests guaranteeing the functionality, quality and safety of the product according to the norms in force or Certificate of conformity of the product issued by a Notified Body.' Literal (g): 'The labelling and instructions for use, translated into the Spanish language.'

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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A locally registered representative is required to hold the device authorisation

operator.local-representative-authorisation
Fact-level verified

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 Poderes, naming the importing company and expressly authorising it to represent, distribute and commercialise the products in Paraguay. Where two or more companies claim to represent the same manufacturer, the exclusive-representative letter wins, and failing that the letter issued directly by the manufacturer beats one issued by a distributor. Withdrawal of the representation must be notified to DINAVISA immediately.

Conditions
  • Document valid for up to two years from issue when no explicit validity is stated.
  • The document must state the legal name and full address of the manufacturer and of the importer, and the express authorisation to represent, distribute and commercialise in Paraguay.
  • Legal documents of foreign origin must be consularised and legalised or apostilled and translated into Spanish.

Effective from 2024-09-16

Source language: Spanish. Translation: 'Power of representation or authorisation letter for distribution and commercialisation from the manufacturer, registered in the Public Registry of Powers, valid for up to two (2) years from its issue when no validity is explicitly indicated in the document... The document must contain the following information: legal name and full address of the legal manufacturer; legal name and full address of the importing company (applicant); and express authorisation for the importing company (applicant) to represent and/or distribute and commercialise its products in Paraguay.'

Responsible technician declares the class; applicant and technician answer for authenticity

operator.responsable-tecnico-and-applicant-liability
Fact-level verified

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 technician. DINAVISA may verify the truth of the documentation at any time; the applicant and the responsible technician are responsible for the integrity and authenticity of the information, documents and declarations filed.

Conditions
  • Applies to all device classes.
  • For IVDs the technical director must hold a university degree in biochemistry.

Effective from 2024-09-16

Source language: Spanish. Translation of Art. 31: 'The DINAVISA shall have the power to verify at any time the truthfulness of the documentation filed in the procedures framed in this Resolution; the applicant and the Responsible Technician are responsible for the integrity and authenticity of the information, documentation and declarations offered.' Label item 2 requires 'Name of the responsible technician legally qualified for the function.'

Registration holders are the final owners of quality, safety and efficacy

operator.titular-postmarket-responsibility
Fact-level verified

Companies holding sanitary registrations are the final parties responsible for the quality, safety and efficacy of their medical devices and must implement and maintain a documented system for collecting and managing reports of adverse events and incidents and safety information generated by their products, including communicating alerts and measures taken abroad.

Conditions
  • Applies to holders of sanitary registrations of medical devices.
  • Companion duties in the same article include communicating alerts issued abroad.

Effective from 2023-09-07

Source language: Spanish. Translation: 'Companies holding Sanitary Registrations are the final parties responsible for the quality, safety and efficacy of their medical devices and must implement and maintain a documented system allowing the collection and management of reports of adverse events and incidents and safety information generated by their products.'

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Establishment opening, renewal and modification regime replaced earlier DINAVISA resolutions

establishment.apertura-renovacion-and-modifications-regime
Fact-level verified

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 for pharmacies (Art. 9) and for production laboratories, quality-control laboratories, fractioning and packaging plants and magistral-preparation pharmacies (Art. 10), and keeps previously issued establishment authorisations valid until their own expiry date (Art. 11). Applications already in progress through DINAVISAPy when the resolution took effect continue under the rules in force at the time of their filing (Art. 12). It abrogates Resolución DNVS DG N° 001 of 13 January 2021 and Resolución DINAVISA N° 25 of 8 March 2022, and any provision contrary to it (Art. 14).

Conditions
  • In force ten business days after the date of its signature (Art. 15); the signature date is 20 June 2025 per the resolution's header, so the entry into force date is not stated as a calendar date in the text.
  • Authorisations already issued stay valid until their own expiry; after that, renewal and modification follow the new resolution.

Source language: Spanish. Translation of Art. 1: 'To regulate the procedures for opening, renewal of opening and modification of public and private establishments regulated by DINAVISA, in accordance with the provisions of this Resolution.' Art. 14: 'To abrogate Resolution DNVS DG N°001 of 13 January 2021 and Resolution DINAVISA N° 25 of 8 March 2022, as well as any provision contrary to this Resolution.' No effectiveFrom is recorded because the text fixes the entry into force relative to the signature rather than to a stated calendar date.

Manufacturers, importers and distributors need a valid BPFyC/BPAyD certificate

establishment.bpfyc-bpayd-certificate-mandatory
Fact-level verified

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 a valid certificate of compliance with Good Manufacturing and Control Practices (BPFyC) and/or Good Storage and Distribution Practices (BPAyD). The inspection procedure covers classes I, II, III and IV.

Conditions
  • Inspections are carried out by DINAVISA officials, who may enter the establishment even against the owner's refusal; refusal is a serious infraction under Ley N° 1119/97 and Ley N° 6788/21.
  • The certificate of compliance is valid for three years (36 months).

Source language: Spanish. Translation of Art. 1: 'To establish the inspection procedure for verification of Good Manufacturing and Control Practices (BPFyC) and Good Storage and Distribution Practices (BPAyD) for production, fractioning and packaging, importing, exporting and distributing laboratories of medical devices, sharps and class I, II, III and IV personal protective equipment.' Art. 2's text ('Disponer que para el funcionamiento de los laboratorios ... es obligatorio que el establecimiento cuente con el certificado de cumplimiento de BPFyC y/o BPAyD vigente') was read from the official PDF page image because the OCR text layer dropped that clause; Art. 1's wording is quoted here because it survived OCR verbatim.

BPFyC/BPAyD certification is valid three years and is renewed on application with fees

establishment.bpfyc-certificate-validity-and-renewal
Fact-level verified

The BPFyC and BPAyD certification is valid for three years (36 months), computed as set out in Art. 5 of the resolution. To renew, the establishment must file the application and pay the corresponding fees to DINAVISA within the ninety (90) days before expiry (Art. 6). Where a certificate is renewed before the establishment has been inspected, the renewed certification may be revoked depending on the result of the later inspection (Art. 9).

Conditions
  • Inspections are performed by DINAVISA officials (Art. 3).
  • The certificate must be in force for the establishment to operate (Art. 2).

Source language: Spanish. Translation: 'To establish that the validity of the BPFyC and BPAyD certification shall be 3 years (thirty-six months).' and 'the establishment must file the application and pay the corresponding fees before DINAVISA'. Art. 4's wording survived OCR verbatim; the revocation sentence appears immediately before it in the same page region.

Fees

What regulator fee applies to this class, route, event, and date?

Compare countries

Device registration, renewal and modification tariffs for 2026-2027

fees.device-registration-tariffs-2026-2027
Fact-level verified

The DINAVISA 2026-2027 tariff table sets device registration fees in multiples of the jornal mínimo (Gs. 117.077): family registration of class I national 10 jornales (Gs. 1.170.770); class I imported 15 (Gs. 1.756.155); class II imported 20 (Gs. 2.341.540); class III imported 25 (Gs. 2.926.925); class IV imported 30 (Gs. 3.512.310). Class I national renewal is 8 jornales (Gs. 936.616) and class I national modification 5 (Gs. 585.385).

Conditions
  • Tariff codes: 480-283 (class I national registration), 480-287 (class I imported), 480-295 (class II imported), 480-303 (class III imported), 480-311 (class IV imported), 480-284 (class I national renewal), 480-285 (class I national modification), 480-312 (class IV imported renewal, 28 jornales), 480-313 (class IV imported modification, 5 jornales).
  • Fees are stated for a family registration (Registro de Familia), not per individual model.
  • Because fee figures are subject to 12-month re-verification, this needs rechecking after 2027.

Source language: Spanish. The table is a borderless multi-column layout whose OCR interleaves concept text and row values; the code, jornal-count and amount columns were read by column alignment. Amounts as printed: 480-283 'Registro de Familia ... Clase I Nacional' 10 / 117.077 / 1.170.770; 480-287 '... Clase I Importado' 15 / 117.077 / 1.756.155; 480-295 '... Clase II Importado' 20 / 117.077 / 2.341.540; 480-303 '... Clase III Importado' 25 / 117.077 / 2.926.925; 480-311 '... Clase IV Importado' 30 / 117.077 / 3.512.310. Rows for 480-288 and adjacent renewal lines are excluded because their concept text drifted in OCR.

Import despatch authorisation and advertising-piece tariffs

fees.import-despacho-and-advertising-tariffs
Fact-level verified

The same 2026-2027 table prices, under ARANCELES PARA DESPACHOS, an import authorisation for registered companies (authorisation to import medical devices) at 2 jornales (Gs. 234.154, code 480-174); and, under ARANCELES PARA PUBLICIDAD, advertising pieces at 2 jornales for written media (480-117), 2 for radio and oral media (480-118) and 3 for audiovisual media, TV and cinema (480-119).

Conditions
  • The despacho tariff applies to companies already registered with DINAVISA.
  • The advertising tariffs are charged per advertising piece in each medium.

Source language: Spanish. Printed rows: '480-174 Para empresas registradas (Autorización p/ importación de Dispositivos Médicos). 2 117.077 234.154'; '480-117 Medio de comunicación escrito con pieza publicitaria. 2 117.077 234.154'; '480-118 Medio de comunicación radial y oral en general con pieza publicitaria. 2 117.077 234.154'; '480-119 Medio de comunicación audiovisual (TV CINE) con pieza publicitaria. 3 117.077 351.231'.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

Compare countries

Labels must carry the tecnovigilancia adverse-event reporting legend

label.adverse-event-reporting-legend
Fact-level verified

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 reported by completing the notification form available at the DINAVISA tecnovigilancia page and sent to the tecnovigilancia@dinavisa.gov.py address.

Conditions
  • Applies to every product under the resolution.
  • DINAVISA may require further elements to guarantee traceability or safety.

Effective from 2024-09-16

Source language: Spanish. Translation: 'All products must include on the label, labelling or in their instructions for use the legend: In case of suspicion of an incident/adverse event attributable to the medical device, report by completing the Notification Form available at https://dinavisa.gov.py/tecnovigilancia/ and sending it to the address tecnovigilancia@dinavisa.gov.py.' The OCR of the official PDF renders the URL as 'hitps' and mangles the email address; the quoted text normalises those OCR artefacts only.

Instructions for use must be translated into Spanish

label.ifu-translation-into-spanish
Fact-level verified

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 duty to put mandatory information in Spanish or on a complementary Spanish label.

Conditions
  • Applies to imported devices; national products are covered by the label article.

Effective from 2024-09-16

Source language: Spanish. Translation: 'The labelling and instructions for use, translated into the Spanish language.' The quoted fragment is literal and complete as it appears in Art. 6(g).

Labels must be in Spanish; fourteen required label elements

label.spanish-language-mandatory
Fact-level verified

The information on the label of a medical device must be written in Spanish. Where mandatory information is not in the official language, it must be added on a complementary Spanish-language label. If a specific technical regulation requires complementary information because of the product's specificity, it is added to the label or to the instructions for use as applicable. The resolution lists fourteen label requirements, beginning with the trade name, brand, legal name and address of manufacturer, importer and distributor, the name of the responsible technician, the DINAVISA authorisation legend and the authorised sale condition.

Conditions
  • Applies to all device classes.
  • Instructions for use are dealt with separately in Art. 6(g), which requires them translated into Spanish.
  • DINAVISA may require additional elements where necessary to guarantee traceability or product safety.

Effective from 2024-09-16

Source language: Spanish. Translation: 'To establish that the information on the label or labelling of medical devices must be written in the Spanish language. Where the mandatory information is not in the official language, it must be included on the complementary label in the Spanish language.' Label items quoted: '1) Trade name, brand, legal name and address of the manufacturer, of the importer and distributor where applicable. 2) Name of the responsible technician legally qualified for the function. 3) The legend AUTORIZADO POR DINAVISA followed by the Sanitary Registration or NSO number issued by DINAVISA.'

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

Compare countries

Holders must run a documented vigilance system and relay alerts issued abroad

pms.documented-vigilance-system-and-abroad-alerts
Fact-level verified

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, and must communicate the alerts and measures taken abroad concerning their products.

Conditions
  • Applies to holders of sanitary registrations.
  • Reporting deadlines to DINAVISA are 24 hours for serious incidents, 30 calendar days for non-serious ones and 72 hours for international alerts (Arts. 12 and 13).

Effective from 2023-09-07

Source language: Spanish. Translation: 'Companies holding Sanitary Registrations are the final parties responsible for the quality, safety and efficacy of their medical devices and must implement and maintain a documented system allowing the collection and management of reports of adverse events and incidents and safety information generated by their products.' Obligation 2 in the same article covers communicating alerts and measures taken abroad. This fact carries the manufacturer-side PMS obligation; the same article also supports the operator-roles fact.

Official forms & portals

Which current form, portal, account, and submission package must be used?

Compare countries

Applications, class declarations and establishment procedures run through DINAVISAPy

portal.dinavisapy-submission-and-declaration
Fact-level verified

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 device class there with the technical justification, DINAVISA evaluates the technical information declared there, and establishment opening, renewal and modification applications already in progress also run through that system.

Conditions
  • The portal is operated by DINAVISA/MSPBS.
  • The system also handles establishment authorisations (Res. DINAVISA N° 226/2025 Art. 12).

Effective from 2024-09-16

Source language: Spanish. Translation: 'the responsible technician of the applicant must declare the Class of the medical device in the platform of the Integrated Computer System for the Management of Sanitary Registrations and Health Establishments - DINAVISAPy'; and, in Art. 8(a), 'DINAVISA shall evaluate the technical information declared in the platform of the Integrated Computer System for the Management of Sanitary Registrations and Health Establishments - DINAVISAPy'.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

Compare countries

DINAVISA officials carry out the BPFyC/BPAyD verification inspections

inspection.dinavisa-officials-and-right-of-entry
Fact-level verified

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 treated as a serious infraction under Ley N° 1119/97 and Ley N° 6788/2021.

Conditions
  • Applies to production, fractioning, packaging, importing, exporting and distributing establishments of medical devices, sharps and class I-IV personal protective equipment.
  • The resulting certification is valid three years.

Source language: Spanish. Translation: 'To provide that the inspections shall be carried out by officials of the National Sanitary Surveillance Directorate (DINAVISA).' The right-of-entry and refusal-as-serious-infraction clauses sit in the same article and are described rather than quoted because the OCR text layer fragmented them.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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DINAVISA may impose any measures needed to minimise device risks

recall.dinavisa-risk-minimisation-measures
Fact-level verified

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 regulatory measures on the decisions of reference regulatory agencies.

Conditions
  • Sits in the tecnovigilancia resolution (Arts. 22 and 23).
  • The reference-agency limb is recorded separately under reliance-recognition.

Effective from 2023-09-07

Source language: Spanish. Translation: 'To provide that the National Sanitary Surveillance Directorate may establish the measures necessary to minimise the risks associated with the use of medical devices in order to maintain an adequate balance in the benefit/risk relationship.'

DINAVISA may suspend or cancel a simplified IVD registration and order withdrawal

recall.psr-suspension-cancellation-and-withdrawal
Fact-level verified

For IVDs registered through the simplified process, DINAVISA may suspend or cancel the sanitary registration, prohibit commercialisation, distribution, import, export and elaboration, and require withdrawal from the market, and may initiate the corresponding administrative proceedings.

Conditions
  • Applies to IVDs registered under the PSR of Resolución DINAVISA N° 44/2024.
  • DINAVISA also retains in-situ inspection powers (Art. 5).

Effective from 2024-01-30

Source language: Spanish. Translation: the article empowers DINAVISA to 'suspend or cancel' the registration, to 'prohibit commercialisation, distribution, import, export and elaboration' and to require 'withdrawal from the market', and to initiate the corresponding sumarios. Summarised rather than quoted because the OCR of this scanned page fragments the list.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

Class I: classification declared under oath by the applicant

registration.class-i-sworn-class-declaration
Fact-level verified

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 technician declares the class in the DINAVISAPy platform with a technical justification and DINAVISA may accept or reject it.

Conditions
  • Once the NSO is issued the declared class may not be modified.
  • The classification rules are Annex I of the resolution and may be updated per internationally recognised provisions.

Effective from 2024-09-16

Source language: Spanish. Translation: 'To provide that the responsible technician of the applicant shall declare the Class of the medical device in the platform of the Integrated Computer System for the Management of Sanitary Registrations and Health Establishments - DINAVISAPy, and shall file its technical justification, in accordance with the Classification Rules established in ANNEX I ... DINAVISA shall have the attribution to accept or reject the Classification of devices declared as Class II, III and IV ... The classification of Class I medical devices shall be made under sworn declaration, in accordance with ANNEX II.'

Classes II-IV: sanitary registration certificate, simplified or integral track

registration.class-ii-iv-certificado-registro-sanitario
Fact-level verified

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-approval modifications and renewals. Imported class II-IV applications are sorted by class and either take the simplified registration process (if authorised by a listed reference authority) or the integral analysis track that examines every item of Art. 6.

Conditions
  • Class II-IV applications are filed in the DINAVISAPy platform with the responsible technician's technical justification (Art. 4).
  • DINAVISA may accept or reject the declared class for classes II, III and IV.

Effective from 2024-09-16

Source language: Spanish. Translation of Art. 5: 'To establish that this Resolution shall apply to applications for registration, post-approval modification and renewal of Sanitary Registrations of medical devices categorised as Classes II, III, IV (and their accessories) of national or imported origin, as well as to applications for registration, post-issue modification and renewal of the Mandatory Sanitary Notification (NSO) of medical devices categorised as Class I (and their accessories) of national or imported origin.' Art. 8(b) sends products not reached by the simplified requirements to integral analysis.

IVDs: sanitary registration plus establishment authorisation

registration.ivd-sanitary-registration-and-establishment-authorisation
Fact-level verified

In-vitro diagnostic products must hold a sanitary registration granted by DINAVISA for their manufacture, import, export, conditioning, distribution and commercialisation, and the applicant establishment must first be authorised in the corresponding line of business under MERCOSUR GMC Resolution N° 21/98 as internalised by Decreto N° 2885/1999. A technical director with a university degree in biochemistry is required.

Conditions
  • MERCOSUR internalisation cited as Decreto N° 2885 of 10 May 1999, in force in MERCOSUR since 5 May 2016 (Art. 40, Protocol of Ouro Preto).
  • IVD risk classes I-IV are set by Art. 9 of the same resolution.

Source language: Spanish. Translation: 'The In Vitro Diagnostic Products defined in article 2 must hold a Sanitary Registration granted by DINAVISA for their elaboration, import, export, conditioning, distribution and commercialisation, following authorisation of the applicant establishment in the corresponding line of business as established in GMC Resolution N° 21/98 Technical Regulation relating to the Operating Authorisation of Manufacturing and/or Importing Companies of Medical Products, internalised by Decree N° 2885 of 10 May 1999 and in force in Mercosur since 05 May 2016 (Article 40 - Protocol of Ouro Preto).'

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Paraguay approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Paraguay (15 records)

ParaguaySource authority not specified

Prior approval / evidence record

Proceso simplificado de Registro Sanitario for class II-IV devices

Name

Proceso simplificado de Registro Sanitario for class II-IV devices

Description

Resolución DINAVISA N° 226/2024 Art. 8(a) submits a class II, III or IV device already authorised by an authority of a country on the Listado Anual Oficial to a 45-business-day evaluation of items b), c), d), g) and h) of Art. 6 instead of the 120-business-day integral analysis.

Timeline Reduction

From 120 business days to 45 business days

Eligibility
  • Device classified by DINAVISA as class II, III or IV
  • Prior authorisation by a regulatory authority of a country on the Listado Anual Oficial emitted under Ley N° 7256/2024 Art. 3, or by an authority with a published bilateral recognition agreement
  • All Art. 6 requirements still filed
Resolución DINAVISA N° 226/2024, Arts. 9, 10, 11 y 14 — plazos del Proceso simplificado e integral, validez, renovación y modificaciones del registro sanitario de dispositivos médicosResolución DINAVISA N° 266/2022, Arts. 6, 7 y 15 — plazos de expedición del registro sanitario de productos para diagnóstico de uso in vitro y su vigenciaResolución DINAVISA N° 44/2024, Arts. 2 y 7 — Proceso Simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

ParaguaySource authority not specified

Prior approval / evidence record

MERCOSUR health resolutions internalised as technical regulation, not as authorisation recognition

reliance.mercosur-harmonisation-not-authorisation-recognition
Fact-level verified
Statement

Paraguay internalised the MERCOSUR GMC health resolutions of Subgrupo de Trabajo N° 11 by Decreto N° 10403/2012, including GMC 20/11 (MERCOSUR technical regulation on good manufacturing practice for medical products and IVDs) and GMC 23/11 (exchange of information on serious adverse events caused by medical products). These are harmonised requirements, not recognition: the decree incorporates technical regulations and creates no route by which another MERCOSUR member's marketing authorisation is accepted in Paraguay.

Source Approval

none

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • GMC 20/11 is cited in the decree as 'Reglamento Técnico MERCOSUR de Buenas Prácticas de Fabricación de Productos Médicos y Productos para Diagnóstico de Uso In Vitro (Derogación de las Resoluciones GMC No 04/95, 38/96, 65/96 y 131/96)'.
  • GMC 23/11 is cited as 'Mecanismo de intercambio de información sobre eventos adversos graves causados por productos médicos utilizados en el MERCOSUR (Derogación de la Resolución GMC No 46/08)'.
  • Separately, Res. DINAVISA N° 266/2022 Annex I lists the full MERCOSUR members among the countries whose products get the 30-business-day IVD clock, and Art. 3 of that resolution makes establishment authorisation follow GMC 21/98 as internalised by Decreto N° 2885/1999.

Source language: Spanish. Translation of the decree's title: 'By which the following resolutions of the Common Market Group linked to MERCOSUR's Working Subgroup No. 11 Health are incorporated into the national legal order: 69/06, 15/09, 16/09, 38/09, 18/10, 19/10, 20/10, 21/10, 48/10, 07/11, 08/11, 09/11, 18/11, 19/11, 20/11, 21/11, 22/11, 23/11, 24/11 and 31/11.' Art. 1 opens 'Incorpórense al ordenamiento jurídico nacional las siguientes Resoluciones aprobadas por el Grupo Mercado Común del MERCOSUR'. The decree's day of signature is illegible in the scan and is not reproduced.

ParaguayEU conformity assessment · US FDA · South Korea MFDS · Japan MHLW / PMDA

Prior approval / evidence record

Compassionate-use import where the device is authorised by a listed reference agency

reliance.compassionate-use-foreign-authorised-product
Fact-level verified
Statement

A device that has no Paraguayan sanitary registration may be imported for compassionate use where it has been authorised by a foreign reference regulatory agency included in the annual official list under Ley N° 7256/2024, and is required to treat a patient or group of patients urgently as determined by the treating specialist or the MSPBS. The route is an import authorisation, not a registration.

Source Approval

Authorisation by a foreign reference regulatory agency included in the Listado Anual Oficial under Ley N° 7256/2024 (2026 list: US FDA, EU Commission/EMA, Japan MHLW/PMDA, Korea MFDS, ANMAT, ANVISA, ISP and others)

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • No DINAVISA registration may exist for the product.
  • Urgency determined by the treating specialist or by the MSPBS.
  • Requires an import authorisation under the resolution's requirements (Art. 3 et seq.).
  • Companion limb (Art. 2(a)) covers products in the investigational phase, where no foreign authorisation is required.

Effective from 2025-06-30

Source language: Spanish. Translation: 'Medicines or medical devices Registered by a Regulatory Authority: Medicines or medical devices that have been authorised by a foreign reference regulatory agency included in the official annual list pursuant to Law N° 7256/2024 or its updates, that do not have a sanitary registration issued by DINAVISA and that are required to treat a patient or group of patients urgently, determined by the treating specialist physician, or the Ministry of Public Health and Social Welfare.' Art. 12 (OCR renders it 'Artículo 129') sets the resolution in force from 30 June 2025.

ParaguayBrazil ANVISA · US FDA · Health Canada · Austria · Belgium · Denmark · Finland · France · Germany · Hungary · Ireland · Italy · Netherlands · New Zealand · Norway · Spain · Sweden · Japan MHLW / PMDA · UK MHRA · Swissmedic · Australia TGA · WHO

Prior approval / evidence record

IVD Annex I reference-country list drives the 30/45/120-business-day clocks

reliance.ivd-anexo-i-reference-country-list
Fact-level verified
Statement

For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free-sale certificate), and within 120 business days for other imports. Annex I names high-surveillance and adequate-surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not.

Source Approval

Sanitary registration and free-sale certificate in force in an Annex I country — high-surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate-surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The Annex I list derives from Ley N° 3283/2007 Art. 11 (high and adequate sanitary surveillance).
  • A product made outside Annex I is admitted on a 45-day clock only if it is registered and commercialised in an Annex I country.
  • Korea (MFDS) does not appear in Annex I, so a Korean-only IVD authorisation does not by itself reach the 30/45-day clocks.
  • A Paraguayan sanitary registration is still required in every case.

Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.

ParaguaySource authority not specified

Prior approval / evidence record

Post-market risk measures may be based on reference-agency decisions

reliance.postmarket-measures-reference-agency-decisions
Fact-level verified
Statement

In post-market risk management DINAVISA may base the regulatory measures it adopts to minimise risks associated with the use of medical devices on the decisions of reference regulatory agencies. This is a post-market reliance mechanism: no application is filed and it confers no market access.

Source Approval

Reference regulatory agencies generally, as named in Res. DINAVISA N° 361/2023 — no list is given in this article

Edge Type

Abridged Or Recognition Route

Market Access Strength

none

Regulatory Layer

Postmarket Review

Local Application Required

No

Target Decision Retained

Yes

Conditions
  • Post-market layer only (Art. 23 sits in the tecnovigilancia resolution).
  • Companion power in Art. 22: DINAVISA may establish the measures necessary to minimise risks and keep an adequate benefit/risk balance.

Effective from 2023-09-07

Source language: Spanish. Translation: 'To establish that the National Sanitary Surveillance Directorate may base the regulatory measures it adopts to minimise the risks associated with the use of medical devices on the decisions of the reference regulatory agencies.'

ParaguayWHO · IMDRF member authorities

Prior approval / evidence record

PAHO/WHO reference authority or IMDRF Management Committee member authority

Authority

PAHO/WHO reference authority or IMDRF Management Committee member authority

Accepted

Yes

Benefit

Operative for class II, III and IV IVDs, which enter the Proceso Simplificado de Registro Sanitario under Resolución DINAVISA N° 44/2024 with a 15-business-day validation and approval by positive silence.

Resolución DINAVISA N° 226/2024, Arts. 9, 10, 11 y 14 — plazos del Proceso simplificado e integral, validez, renovación y modificaciones del registro sanitario de dispositivos médicosResolución DINAVISA N° 266/2022, Arts. 6, 7 y 15 — plazos de expedición del registro sanitario de productos para diagnóstico de uso in vitro y su vigenciaResolución DINAVISA N° 44/2024, Arts. 2 y 7 — Proceso Simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

ParaguayUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

No

Benefit

The US FDA is named in the Listado Anual Oficial (Resolución DINAVISA N° 182/2026), but every published entry of that list states an Alcance of medicamentos and/or vacunas, so the FDA authorisation does not by itself qualify a device for the simplified route; it remains useful as dossier evidence under Art. 6.

Resolución DINAVISA N° 226/2024, Arts. 9, 10, 11 y 14 — plazos del Proceso simplificado e integral, validez, renovación y modificaciones del registro sanitario de dispositivos médicosResolución DINAVISA N° 266/2022, Arts. 6, 7 y 15 — plazos de expedición del registro sanitario de productos para diagnóstico de uso in vitro y su vigenciaResolución DINAVISA N° 44/2024, Arts. 2 y 7 — Proceso Simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

ParaguaySource authority not specified

Prior approval / evidence record

Class I devices: notification by sworn declaration, no foreign approval required

reliance.class-i-nso-no-foreign-approval
Fact-level verified
Statement

Class I devices enter the Paraguayan market through a Notificación Sanitaria Obligatoria (NSO): the applicant files the Art. 6 requirements plus a sworn declaration that the device is class I, and DINAVISA issues the notification, which itself authorises manufacture or import. No foreign approval is required to obtain it and no foreign approval shortens or replaces it.

Source Approval

none

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Applies to class I medical devices and their accessories, national or imported (Res. 226/2024 Art. 5).
  • The Art. 6 documentary set still applies in full, including the origin-country free-sale certificate for imported devices.
  • The declared class may not be modified once the NSO is issued.
  • NSO validity is ten years (Art. 10).

Effective from 2024-09-16

Source language: Spanish. Translation of the quoted passage: 'The registration of products which under the Medical Device Classification Rules correspond to class I shall have the character of a Mandatory Sanitary Notification (NSO), for which DINAVISA shall issue the corresponding document, which shall be valid for the purposes of authorising manufacture or automatic import of class I medical devices of national and imported origin.' The second quoted sentence requires applications to follow Art. 6 together with the sworn declaration that the device is class I.

ParaguaySource authority not specified

Prior approval / evidence record

Origin-country free-sale certificate or registration certificate is mandatory paperwork

reliance.origin-country-free-sale-certificate
Fact-level verified
Statement

Every imported device application must include a free-sale certificate, or evidence of sanitary registration, or an equivalent document issued by the competent authority of the country where the device is manufactured and/or commercialised, describing the product and its models. This is a required document evaluated inside the local review, not a route that shortens it, and it is one of the items DINAVISA re-examines even in the simplified process.

Source Approval

A free-sale certificate, sanitary-registration certificate or equivalent issued by the competent authority of the country of manufacture and/or commercialisation (any country, not only a reference country)

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Document valid for up to two years from issue when no explicit validity is stated in the document.
  • Legal documents of foreign origin must be consularised and legalised, or apostilled, and translated into Spanish by a public translator registered with the Supreme Court of Justice.
  • Under Art. 8(a) DINAVISA re-evaluates this document (item d) even on the simplified track.

Effective from 2024-09-16

Source language: Spanish. Translation: 'Free-sale certificate or proof of Sanitary Registration or equivalent document, declaring the detailed description of the product and its models as applicable, issued by the competent authority of the country where it is manufactured and/or commercialised, valid for up to two (2) years from its issue when no validity is explicitly indicated in the document.' The quoted fragment ends at 'vigencia' because the sentence continues on the next page of the scanned PDF.

ParaguayEU conformity assessment · US FDA · South Korea MFDS · Japan MHLW / PMDA

Prior approval / evidence record

Annual official list names FDA, EU, PMDA and MFDS but every entry is scoped to medicines or vaccines

reliance.annual-official-list-device-scope-gap
Fact-level verified
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 every entry's stated 'Alcance' is medicamentos and/or vacunas. No listed authority, and no separate list entry, is scoped to dispositivos médicos, so on the published instrument the simplified device route is not anchored to any device-scoped reference authority.

Source Approval

none

Edge Type

International Listing

Market Access Strength

none

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The 2026 list is emitted by Resolución DINAVISA N° 182/2026 in compliance with Art. 3 of Ley N° 7256/2024; it abrogates Resolución DINAVISA N° 148/2024 and Resolución DINAVISA N° 192/2025.
  • The listed agencies' own names include medical devices (AEMPS, JAZMP, URPL), but their stated Alcance in this list is medicamentos y vacunas.
  • This fact records the list's stated scope only; it is not evidence that DINAVISA refuses device reliance in practice, and no DINAVISA instrument was found that scopes the device route to a named device authority.

Effective from 2026-05-01

Source language: Spanish. Translation of the quoted entries: 'United States: US FDA. Scope: Medicines and vaccines.' / 'European Commission (DG SANTE); European Medicines Agency (EMA); National Regulatory Authorities. Scope: Medicines and vaccines.' / 'Republic of Korea: Ministry of Food and Drug Safety (MFDS). Scope: Medicines and vaccines.' / 'Japan: Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA). Scope: Medicines' and a second Japan entry 'Pharmaceuticals and Medical Devices Agency (PMDA). Scope: Vaccines'. The resolution is dated 'de mayo de 2026'; the day glyph is illegible in the scan and is not reproduced. effectiveFrom is the month of signature only.

ParaguayEU conformity assessment · US FDA · South Korea MFDS · Japan MHLW / PMDA

Prior approval / evidence record

Simplified registration route for class II-IV devices authorised by a listed reference authority

reliance.annual-official-list-simplified-route
Fact-level verified
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 a published bilateral recognition agreement enters the 'Proceso simplificado de Registro Sanitario' instead of full integral analysis. The applicant still files every Art. 6 requirement and still needs a Paraguayan registration, but DINAVISA re-examines only items b), c), d), g) and h) of Art. 6 rather than the whole dossier.

Source Approval

Any marketing authorisation issued by an authority of a country on the Listado Anual Oficial — the 2026 list (Resolución DINAVISA N° 182/2026) names US FDA, European Commission (DG SANTE)/EMA and EU national authorities, Japan MHLW/PMDA, Korea MFDS, Singapore HSA, Indonesia BPOM, ANMAT, ANVISA and ISP — each entry stated as scoped to medicamentos and/or vacunas

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Applies to applications for IMPORTED class II, III and IV medical devices and their accessories: Art. 8's chapeau reads 'las solicitudes de inscripción de Dispositivos Médicos importados deberán ajustarse y tramitarse según la Clase... (Clase II, III y IV)'.
  • The foreign authorisation must come from an authority of a country on the Listado Anual Oficial emitted under Ley N° 7256/2024, or from an authority with a bilateral recognition agreement that so provides, published on the DINAVISA website.
  • The applicant still files all requirements of Art. 6; DINAVISA evaluates the technical information declared in DINAVISAPy and the documents filed for items b), c), d), g) and h).
  • Only if the conditions do not differ from what the origin regulatory authority authorised.
  • 45-business-day evaluation clock under Art. 9.
  • Res. 226/2024 Art. 8(a) names the 2024 list (Resolución DINAVISA N° 148/2024); that list was replaced by Res. 192/2025 and then by Res. 182/2026, the text referring to the list 'y sus actualizaciones'.

Effective from 2024-09-16

Source language: Spanish. Translation: 'Applications for registration of products classified by DINAVISA as class II, III and IV medical devices that are authorised by authorities of the countries on the Annual Official List emitted in Resolución DINAVISA N° 148/2024 and its updates, as well as those Regulatory Authorities with which bilateral agreements for the recognition of authorisations exist, which so provide, published on the DINAVISA website, shall be subject to the simplified Sanitary Registration Process.' OCR of the two-column official PDF was normalised: 'Clase l' rendered as 'Clase II' and 'N*148/2024' as 'N°148/2024'.

ParaguayEU conformity assessment

Prior approval / evidence record

EU CE marking / EU notified body certificate

Authority

EU CE marking / EU notified body certificate

Accepted

No

Benefit

The European Commission (DG SANTE), EMA and EU national authorities appear in the Listado Anual Oficial with an Alcance of medicamentos and vacunas; a CE certificate is accepted as quality-system evidence under Art. 6(a) but does not replace Paraguayan registration.

Resolución DINAVISA N° 226/2024, Arts. 9, 10, 11 y 14 — plazos del Proceso simplificado e integral, validez, renovación y modificaciones del registro sanitario de dispositivos médicosResolución DINAVISA N° 266/2022, Arts. 6, 7 y 15 — plazos de expedición del registro sanitario de productos para diagnóstico de uso in vitro y su vigenciaResolución DINAVISA N° 44/2024, Arts. 2 y 7 — Proceso Simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

ParaguayBrazil ANVISA · EU conformity assessment · US FDA · Health Canada · Singapore HSA · IMDRF member authorities · Portugal · Spain · South Korea MFDS · Japan MHLW / PMDA · UK MHRA · NMPA · Taiwan TFDA · Australia TGA · WHO

Prior approval / evidence record

IVD simplified registration (PSR) for products authorised by PAHO/WHO, IMDRF or bilateral-partner authorities

reliance.ivd-psr-reference-authorities
Fact-level verified
Statement

Class II, III and IV in-vitro diagnostic products already authorised and commercialised in countries regulated by PAHO/WHO reference regulatory authorities, by authorities of IMDRF Management Committee member countries, or by authorities with bilateral agreements with DINAVISA enter the Proceso Simplificado de Registro Sanitario (PSR). DINAVISA has 15 business days to validate and decide, and approval follows by positive silence if no report is issued.

Source Approval

PAHO/WHO reference regulatory authorities; authorities of IMDRF Management Committee member countries (the IMDRF committee includes US FDA, EU, Japan PMDA/MHLW, Health Canada, TGA, ANVISA, China NMPA, Korea MFDS, Singapore HSA and UK MHRA); authorities with bilateral agreements with DINAVISA

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Applies to class II, III and IV IVDs (Res. 44/2024 Art. 7: 'Clases II, III y IV'); class I IVDs are registered automatically under Res. 266/2022 Art. 14.
  • The IVD must actually be commercialised in one of those countries and the foreign registration must correspond specifically to the same product being registered.
  • 15 business days to validate; approval by positive silence.
  • Objections may be answered only once (Art. 3), with 30 business days to rectify.
  • Not applicable to the cases in Arts. 13 and 16 of Res. DINAVISA N° 266/2022 (Art. 11).

Effective from 2024-01-30

Source language: Spanish. Translation of the operative part of Art. 2: 'Applications for sanitary registration of In Vitro Diagnostic Products ... that are authorised and commercialised in countries regulated by: PAHO/WHO Reference Regulatory Authorities; Regulatory Authorities of member countries of the Committee of the International Medical Device Regulators Forum - IMDRF; Regulatory Authorities with which bilateral agreements with DINAVISA exist, shall be subject to the Simplified Sanitary Registration Process (PSR).' and 'DINAVISA shall have a term of 15 (fifteen) business days to validate the required documentation and decide thereon. Once the term has elapsed with no report from DINAVISA, the application shall be approved.' Article numbering confirmed by reading the page image of the official PDF.

ParaguayWHO · IMDRF member authorities

Prior approval / evidence record

Proceso simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro

Name

Proceso simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro

Description

Class II, III and IV IVDs (Res. 44/2024 Art. 7) already authorised and commercialised by a recognised reference authority are validated in 15 business days with approval by positive silence, instead of the 30, 45 or 120 business days of the ordinary IVD route.

Timeline Reduction

From 30-120 business days down to 15 business days

Eligibility
  • Product classified as class II, III or IV under Resolución DINAVISA N° 266/2022 Art. 9
  • Current authorisation and commercialisation in a country regulated by a PAHO/WHO reference regulatory authority, by an IMDRF Management Committee member authority, or by an authority with a bilateral agreement with DINAVISA
  • The foreign registration must correspond specifically to the same product being registered in Paraguay
Resolución DINAVISA N° 226/2024, Arts. 9, 10, 11 y 14 — plazos del Proceso simplificado e integral, validez, renovación y modificaciones del registro sanitario de dispositivos médicosResolución DINAVISA N° 266/2022, Arts. 6, 7 y 15 — plazos de expedición del registro sanitario de productos para diagnóstico de uso in vitro y su vigenciaResolución DINAVISA N° 44/2024, Arts. 2 y 7 — Proceso Simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

ParaguaySource authority not specified

Prior approval / evidence record

Combined devices evaluated following reference-authority scientific decisions

reliance.combined-devices-reference-authority-decisions
Fact-level verified
Statement

Combined medical devices are evaluated following the scientific-technical decisions of reference regulatory authorities; applicants may nonetheless be subject to further technical and administrative requirements for registration.

Source Approval

Reference regulatory authorities generally, as named by the instrument — no list is given in this article

Edge Type

Abridged Or Recognition Route

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Applies to combined devices (device combined with a medicinal product or other regulated component).
  • DINAVISA may still raise new technical and administrative requirements.

Effective from 2024-09-16

Source language: Spanish. Translation: 'To establish that combined medical devices shall be evaluated following scientific-technical decisions of reference Regulatory Authorities. Notwithstanding that, applicants may be subject to new technical and administrative requirements for the registration of the corresponding product.' The article names no concrete authority and creates no documentary shortcut, so marketAccessStrength is evidence_only.

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Applicants have 60 business days to cure deficiencies, 30 business days for a second round; failure or an unsatisfactory evaluation leads to denial (Res. 226/2024, Art. 9)

clocks.deficiency-cure-sixty-then-thirty-business-days
Fact-level verified

After DINAVISA notifies an inconsistency or irregularity in a registration application (under either the 45- or the 120-business-day evaluation track), the applicant must cure it within no more than sixty (60) business days from the first business day after notification; if the reply introduces new information that raises further inconsistencies, the second cure period is no more than thirty (30) business days; if observations are not cured in time or the technical evaluation is unsatisfactory the application is denied.

Conditions
  • Business days counted from the first business day after notification.
  • Applies to both the simplified and the integral-analysis tracks.

Effective from 2024-08-27

English gist: 60-business-day first cure period, 30-business-day second cure period, denial on failure. Complements the existing 45/120-business-day evaluation clocks already recorded from the same article.

Integral analysis route: 120 business days

clocks.integral-analysis-120-business-days
Fact-level verified

For products reached by Art. 8(b) — those not eligible for the simplified route and therefore subject to integral analysis of every Art. 6 item — DINAVISA has 120 business days to evaluate the required documentation and decide.

Conditions
  • Applies to class II-IV applications that do not qualify for the simplified route.
  • A rectification period follows if objections are raised.

Effective from 2024-09-16

Source language: Spanish. Translation: 'For the products reached by article 8, subparagraph b) of this Resolution, DINAVISA shall have a term of one hundred and twenty (120) business days to evaluate the required documentation and decide thereon.' The sentence spans the page break between pp. 13 and 14 of the official PDF and the OCR text layer dropped the middle of it; the numeral 120 was confirmed by reading the page image directly.

IVD clock of 120 business days for imports outside Annex I

clocks.ivd-120-business-days-outside-anexo-i
Fact-level verified

DINAVISA has 120 business days to decide on applications for imported IVDs from outside the countries included in Annex I.

Conditions
  • Applies to IVD imports from countries not in Annex I that are not registered and commercialised in an Annex I country.
  • The numeral is legible but the middle of the sentence is obscured by the signature stamp on the scanned original.

Source language: Spanish. Translation: 'DINAVISA shall decide within a term of 120 (one hundred and twenty) business days on the application for authorisation for commercialisation and use of products imported [text obscured by the signature stamp] outside the countries included in Annex I.' Recorded as source-backed-partial because the middle clause is obscured in the scanned original, so the full sentence cannot be quoted verbatim even though the 120-business-day figure is legible.

IVD clocks: 30 business days for national and Annex I products, 45 for Annex I-registered products made elsewhere

clocks.ivd-30-and-45-business-days
Fact-level verified

DINAVISA decides within 30 business days on applications for national products and products of countries included in Annex I of Resolución DINAVISA N° 266/2022. It decides within 45 business days on products manufactured in countries not in Annex I but registered and commercialised in an Annex I country, which must additionally file the sanitary-registration record and free-sale certificate in force in an Annex I country at the time of application.

Conditions
  • Annex I is the Ley N° 3283/2007 Art. 11 high- and adequate-surveillance country list.
  • A Paraguayan sanitary registration is still required.

Source language: Spanish. Translation: 'DINAVISA shall decide within a term of thirty (30) business days on the application for authorisation for commercialisation and use of products of national elaboration and countries included in Annex I.' and 'DINAVISA shall decide within a term of forty-five (45) business days on the application submitted, for products elaborated in countries not contemplated in Annex I, but registered and commercialised in countries of the aforementioned annex, which must present, in addition to the documents mentioned in Articles 4 and 5, the Sanitary Registration Record and Free-Sale Certificate in force in countries of Annex I at the time of the application.'

IVD simplified route: 15 business days, approval by positive silence

clocks.ivd-psr-15-business-days-positive-silence
Fact-level verified

Under the IVD simplified registration process DINAVISA has 15 business days to validate the required documentation and decide; if the term elapses with no report from DINAVISA the application is approved.

Conditions
  • Applies to class II, III and IV IVDs (Art. 7) authorised and commercialised in a country regulated by an OPS/OMS reference authority, an IMDRF-committee authority, or an authority with a bilateral agreement with DINAVISA.
  • Objections raised during validation may be answered only once, within 30 business days (Art. 3).
  • DINAVISA retains in-situ inspection, suspension and cancellation powers (Arts. 5 and 6).

Effective from 2024-01-30

Source language: Spanish. Translation: 'DINAVISA shall have a term of 15 (fifteen) business days to validate the required documentation and decide thereon. Once the term has elapsed with no report from DINAVISA, the application shall be approved.' This is the only Paraguayan device or IVD route in which silence operates as approval.

Simplified registration route: 45 business days

clocks.simplified-route-45-business-days
Fact-level verified

For the simplified registration process DINAVISA has 45 business days to evaluate the documentation required by Art. 8(a) and decide. If the evaluation reveals an inconsistency or irregularity, the applicant is notified.

Conditions
  • Applies to class II-IV applications that qualify for the simplified route.
  • A rectification period applies where DINAVISA raises inconsistencies.

Effective from 2024-09-16

Source language: Spanish. Translation: 'For the simplified Sanitary Registration Process, DINAVISA shall have a term of forty-five (45) business days to evaluate the documentation established in article 8, subparagraph a), and decide thereon. If the evaluation of the information submitted by the product holder reveals any inconsistency or irregularity in the information and/or documentation presented, the applicant shall be notified.'

Type II (prior-authorisation) modifications are evaluated within 45 business days, with the same 60/30-business-day cure periods (Res. 226/2024, Art. 14)

clocks.type-ii-modification-forty-five-business-days
Fact-level verified

DINAVISA has forty-five (45) business days to evaluate the documentation for Type II post-authorisation modifications (those that must be authorised before implementation) and decide; inconsistencies are notified and must be cured within sixty (60) business days, with a further thirty (30) business days for issues arising from new information; otherwise implementation of the modification is denied.

Conditions
  • Type I modifications are notified for immediate implementation and carry no evaluation clock (Art. 13).
  • Business days.

Effective from 2024-08-27

English gist: 45-business-day evaluation clock for Type II modifications, 60-day cure, 30-day second cure, denial otherwise.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Compassionate-use import authorisation for unregistered devices

special-access.compassionate-use-import-authorisation
Fact-level verified

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 in the investigational phase and products already authorised by a foreign reference regulatory agency on the annual official list. The interested party must meet the technical and legal requirements of Art. 3.

Conditions
  • In force from 30 June 2025 (Art. 12).
  • Two limbs: investigational-phase products (Art. 2(a)) and products registered by a reference authority (Art. 2(b)).
  • The DINAVISA-reliance limb is recorded separately under reliance-recognition.

Effective from 2025-06-30

Source language: Spanish. Translation: '...medicines and medical devices that do not have a sanitary registration in the country, for compassionate use, in the following cases:' and 'To provide that this Resolution shall be in force as from 30 June 2025.' The OCR renders the article number of the vigencia clause as '129'; the pattern in this document renders '12°' that way.

DINAVISA-authorised importers may import eligible orphan IVDs for their own use

special-access.ivd-import-for-own-use
Fact-level verified

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 importers who import orphan IVDs — products no manufacturing laboratory has a commercial interest in because their development offers no economic incentive despite meeting health needs — and which are not among the Art. 13 exclusions.

Conditions
  • Article 16 of Resolución DINAVISA N° 266/2022; applicants were given 120 days to comply.
  • Res. DINAVISA N° 44/2024 Art. 11 excludes the Art. 16 cases from the simplified IVD route.

Source language: Spanish. Translation: 'Imports under the figure of In Vitro Diagnostic Products imported for own use shall be authorised.' The full conditions of that figure are set out in the article and its annexes and are not restated here.

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

Compare countries

Accepted QMS evidence: origin-authority BPF/GMP, or ISO 13485 / CE / UL / FDA / TUV / MDSAP

standards.accepted-qms-certifications
Fact-level verified

For an imported device, compliance with quality standards in production is evidenced either by a BPF/GMP document issued by the competent sanitary authority in the country of origin or by an ISO 13485, CE, UL, FDA, TUV or MDSAP certificate, or another equivalent certificate issued by a certifying body. For a national product, the same item is a BPF/GMP document issued by DINAVISA or an ISO 13485 or equivalent certificate.

Conditions
  • This is documentary evidence inside the local review, not a recognition route: the certificate family is accepted, not the foreign marketing authorisation.
  • The same certificate family is accepted for renewal (Art. 12).

Effective from 2024-09-16

Source language: Spanish. Translation of the imported limb: 'Documentation credibly evidencing compliance with the quality standards in the production processes BPF / GMP granted by the competent Sanitary Authority in origin or ISO 13485 / CE / UL / FDA / TUV / MDSAP certificate or another equivalent certificate granted by a certifying entity.' National limb: 'BPF / GMP granted by DINAVISA or ISO 13485 certificate or another equivalent certificate granted by a certifying entity.'

DINAVISA may at any time order review, inspection, sampling and testing of any device, at the holder's or importer's cost (Res. 226/2024, Art. 29)

standards.dinavisa-ex-officio-sampling-and-testing-at-holder-cost
Fact-level verified

Article 29 lets DINAVISA order at any time the review, inspection, sampling and ex-officio analysis of any medical device to verify functionality, efficacy, quality and safety for user, patient and environment, and to verify health establishments and device-trading companies under Art. 9 of Ley 4659/2012; the tests, studies, trials or analyses ordered are at the cost of the product holder, or of the importer or manufacturer for devices without registration or NSO.

Conditions
  • Cost falls on the holder; for unregistered devices on the importer or manufacturer.

Effective from 2024-08-27

English gist: ex-officio sampling and testing power, with costs borne by the holder (or importer/manufacturer for unregistered devices).

Finished-product quality-control certificate or Notified Body conformity certificate

standards.finished-product-quality-control-or-conformity
Fact-level verified

An imported device application must include a quality-control certificate for the finished product covering all tests guaranteeing functionality, quality and safety under the applicable norms, or a product conformity certificate issued by a Notified Body.

Conditions
  • Part of the mandatory Art. 6 set.
  • DINAVISA re-examines this item (literal e) even on the simplified route under Art. 8(a).

Effective from 2024-09-16

Source language: Spanish. Translation: 'Quality-control certificate of the finished product with all tests guaranteeing the functionality, quality and safety of the product according to the norms in force or Certificate of conformity of the product issued by a Notified Body.'

Class III and IV safety-and-efficacy summaries are assessed against the MERCOSUR essential requirements of Resolución GMC N° 72/98 (ITR-DGRS-002 v2, p. 5)

standards.mercosur-essential-requirements-gmc-72-98-for-class-iii-iv
Fact-level verified

DINAVISA's application guide requires, for class III and IV devices, a technical summary of efficacy and safety supported by manufacturer documents such as the clinical evaluation, and states that the MERCOSUR Technical Regulation 'Requisitos Esenciales de Seguridad y Eficacia de los productos médicos' (Resolución GMC N° 72/98) and its updates must be taken into account.

Conditions
  • Guide field 'Descripción de Eficacia y Seguridad' on the DINAVISApy platform.
  • Applies to class III and IV devices.

Effective from 2024-09-09

English gist: class III/IV applicants must give a safety-and-efficacy summary backed by the clinical evaluation, framed by MERCOSUR GMC 72/98 essential requirements.

Radiation-emitting devices need a radiation-protection licence from the Autoridad Reguladora Radiológica y Nuclear (ARRN) as part of the registration file (Res. 226/2024, Art. 6 f/h)

standards.radiation-emitting-devices-arrn-licence
Fact-level verified

For both national and imported products, Article 6 of Resolución DINAVISA 226/2024 requires medical devices that emit radiation to hold the Licencia de Protección contra las radiaciones for use and application in human medicine, or an equivalent document, issued by the competent Autoridad Reguladora Radiológica y Nuclear (ARRN) under Paraguayan rules.

Conditions
  • Applies only to devices that emit radiation.
  • Listed as item (f) for national products and item (h) for imported products.

Effective from 2024-08-27

English gist: radiation-emitting devices must carry an ARRN radiation-protection licence (or equivalent) in the dossier. OCR of the scanned resolution checked against the page.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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Applications abandoned by operation of law after twelve months of inactivity

submission.abandonment-after-twelve-months
Fact-level verified

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.

Conditions
  • Applies to device registration applications.
  • Abandonment is automatic ('de puro derecho'), not a discretionary decision.

Effective from 2024-09-16

Source language: Spanish. Translation: 'To determine that registration applications for medical devices shall be considered abandoned and finally closed by operation of law once twelve (12) months have elapsed without the applicant pursuing the process.'

Data entered in the resolution's annexes has sworn-declaration status

submission.annex-data-have-sworn-declaration-status
Fact-level verified

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 and modification notifications carry legal weight.

Conditions
  • Applies to all device classes.
  • Backed by the verification and liability rule of Art. 31.

Effective from 2024-09-16

Source language: Spanish. Translation: 'To establish that the data recorded in ANNEXES I, II, III and IV of this Resolution shall have the character of a sworn declaration.'

After a refusal the applicant may start a fresh registration procedure on payment of the fee

submission.reapplication-after-denial
Fact-level verified

Where a device registration application is refused, the interested party may request a new registration procedure after paying the corresponding fee.

Conditions
  • Applies to device registration applications under Resolución DINAVISA N° 226/2024.
  • A fresh procedure, not an appeal against the refusal.

Effective from 2024-09-16

Source language: Spanish. Translation: 'To establish that in the event of refusal of an application for registration of medical devices, the interested party may request a new registration procedure, after payment of the corresponding fee.'

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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Implant card required for eight categories of implantable devices

traceability.implant-card-for-implantable-devices
Fact-level verified

Implantable devices require an implant card (tarjeta de implantación). The resolution lists the categories as cardiac and central-circulatory vascular implants, central nervous system implants, spinal implants, hip prostheses, knee prostheses, breast implants, intraocular lenses and hearing implants. The card is issued in triplicate by the product supplier, with copies for the clinical history, the patient and the registration holder.

Conditions
  • Applies to the eight listed implant categories.
  • The card is supplied by the product supplier, not by DINAVISA.
  • No UDI carrier or UDI database duty was found in this or the IVD resolution.

Effective from 2024-09-16

Source language: Spanish. Translation of Art. 18: 'The implant card shall be issued in triplicate and must be provided by the supplier of the product.' Art. 17 enumerates the implant categories listed in the statement. This is the only device-traceability obligation identified in the Paraguayan instruments reviewed; it is not a UDI requirement.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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International alerts concerning the holder's devices within 72 hours

vigilance.international-alert-72-hours
Fact-level verified

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 that involves the medical devices they commercialise.

Conditions
  • Applies to holders of sanitary registrations.
  • Runs from knowledge of the alert, not from the alert's own date.

Effective from 2023-09-07

Source language: Spanish. Translation: 'To establish that the Holders of Sanitary Registration must notify the National Sanitary Surveillance Directorate, within a term of 72 (seventy-two) hours following knowledge of the generation of an international alert reported by the parent company or by a health agency worldwide that involves the medical devices they commercialise.'

Serious incidents within 24 hours, non-serious within 30 calendar days

vigilance.reporting-deadlines-serious-and-non-serious
Fact-level verified

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 Paraguay must be reported within 30 calendar days of becoming aware of them. Reporting runs to DINAVISA under the National Tecnovigilancia System.

Conditions
  • Applies to holders of sanitary registrations of medical devices.
  • The 24-hour clock runs from the moment the holder becomes aware of the fact.
  • Holders must maintain a documented system for collecting and managing reports (Art. 10).

Effective from 2023-09-07

Source language: Spanish. Translation: '1. Immediately and within the 24 (twenty-four) hours following the moment of becoming aware of the fact, every serious adverse event or incident occurring in Paraguay. 2. Within a term of 30 (thirty) calendar days following the moment of becoming aware of the fact, the non-serious adverse events or incidents occurring in Paraguay.'

Related structured datasets

Classification systems · 2 records
Open Clases I, II, III y IV — clasificación de Productos para Diagnóstico de Uso In Vitro (Resolución DINAVISA N° 266/2022) →
Id

paraguay:ivd

Jurisdiction Id

paraguay

Domains
  • ivd
Name

Clases I, II, III y IV — clasificación de Productos para Diagnóstico de Uso In Vitro (Resolución DINAVISA N° 266/2022)

Description

In-vitro diagnostic products carry a separate four-class axis set by Resolución DINAVISA N° 266/2022 Art. 9, which classifies by individual risk and public-health risk: class I is low individual and low public-health risk, class II medium individual risk, class III elevated individual and/or medium public-health risk, and class IV elevated individual and elevated public-health risk. Art. 10 refers evaluation to the international classification rules annexed as Anexo III, and Art. 14 registers class I products automatically on a sworn declaration. Classes II, III and IV are the classes to which the simplified IVD registration route of Resolución DINAVISA N° 44/2024 applies (Art. 7).

Classes
  • Id

    i

    Label

    Clase I — riesgo bajo para la salud individual y riesgo bajo para la salud pública

    Normalized Risk Level

    low

  • Id

    ii

    Label

    Clase II — riesgo medio para la salud individual y/o riesgo bajo para la salud pública

    Normalized Risk Level

    medium

  • Id

    iii

    Label

    Clase III — riesgo elevado para la salud individual y/o riesgo medio para la salud pública

    Normalized Risk Level

    high

  • Id

    iv

    Label

    Clase IV — riesgo elevado para la salud individual y riesgo elevado para la salud pública

    Normalized Risk Level

    highest

Regulator

DINAVISA

Official Domains
  • dinavisa.gov.py
Source Status

official-source-verified

Source Title

Resolución DINAVISA N° 266/2022, Arts. 9, 10 y 14 y ANEXO III — clases de riesgo y reglas de clasificación de productos para diagnóstico de uso in vitro

Source Url

https://dinavisa.gov.py/wp-content/uploads/2023/08/Resolucion-DINAVISA-N-266-22.pdf

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Open Clases I, II, III y IV — Reglas de Clasificación de Dispositivos Médicos (Resolución DINAVISA N° 226/2024) →
Id

paraguay:medical-device

Jurisdiction Id

paraguay

Domains
  • medical-device
Name

Clases I, II, III y IV — Reglas de Clasificación de Dispositivos Médicos (Resolución DINAVISA N° 226/2024)

Description

Paraguay's own four-class intrinsic-risk axis. Resolución DINAVISA N° 226/2024 Art. 3 approves the Medical Device Classification Rules in Annex I, which may be updated in line with internationally recognised provisions, and Art. 4 requires the applicant's responsible técnico to declare the device's class in the DINAVISAPy platform. The class determines the registration pathway: class I is granted as a Notificación Sanitaria Obligatoria on a sworn declaration, while classes II, III and IV require a Certificado de Registro Sanitario. There is no MERCOSUR regional class axis in force: Decreto N° 10403/2012 incorporates the GMC resolutions as harmonised requirements only, and Paraguayan registration is what actually happens.

Classes
  • Id

    i

    Label

    Clase I

    Normalized Risk Level

    low

  • Id

    ii

    Label

    Clase II

    Normalized Risk Level

    medium

  • Id

    iii

    Label

    Clase III

    Normalized Risk Level

    high

  • Id

    iv

    Label

    Clase IV

    Normalized Risk Level

    highest

Regulator

DINAVISA

Official Domains
  • dinavisa.gov.py
Source Status

official-source-verified

Source Title

Resolución DINAVISA N° 226/2024, Arts. 3 y 4 y ANEXO I — Reglas de Clasificación de Dispositivos Médicos

Source Url

https://dinavisa.gov.py/wp-content/uploads/2024/09/RESOLUCION-DINAVISA-N%C2%B0226.pdf

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Paraguay registration →
Country

Paraguay

Jurisdiction Id

paraguay

Country Code

PY

Flag

🇵🇾

Regulator

Dirección Nacional de Vigilancia Sanitaria (DINAVISA), Ministerio de Salud Pública y Bienestar Social

Regulator Abbrev

DINAVISA

Region

americas

Tier

3

Risk Classification

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

Classes
  • Id

    class-ii-iv-simplified-registration

    Class Name

    Clases II, III y IV — Proceso simplificado de Registro Sanitario

    Risk Level

    high

    Pathway

    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

    Official Timeline
    Min

    45

    Max

    45

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Resolución DINAVISA N° 226/2024, Arts. 9, 10, 11 y 14 — plazos del Proceso simplificado e integral, validez, renovación y modificaciones del registro sanitario de dispositivos médicos

    Url

    https://dinavisa.gov.py/wp-content/uploads/2024/09/RESOLUCION-DINAVISA-N%C2%B0226.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    3

    Max

    6

    Notes
    • 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.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    class-ii-iv-integral-analysis

    Class Name

    Clases II, III y IV — análisis integral del expediente

    Risk Level

    high

    Pathway

    Integral registration under Resolución DINAVISA N° 226/2024 Art. 8(b): every Art. 6 item is evaluated

    Official Timeline
    Min

    120

    Max

    120

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Resolución DINAVISA N° 226/2024, Arts. 9, 10, 11 y 14 — plazos del Proceso simplificado e integral, validez, renovación y modificaciones del registro sanitario de dispositivos médicos

    Url

    https://dinavisa.gov.py/wp-content/uploads/2024/09/RESOLUCION-DINAVISA-N%C2%B0226.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    6

    Max

    12

    Notes
    • 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.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    post-registration-modification-type-ii

    Class Name

    Dispositivos ya registrados — modificación Tipo II

    Risk Level

    medium

    Pathway

    Post-registration modification filed in DINAVISAPy; Resolución DINAVISA N° 226/2024 distinguishes Type I from Type II modifications

    Official Timeline
    Min

    45

    Max

    45

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Resolución DINAVISA N° 226/2024, Arts. 9, 10, 11 y 14 — plazos del Proceso simplificado e integral, validez, renovación y modificaciones del registro sanitario de dispositivos médicos

    Url

    https://dinavisa.gov.py/wp-content/uploads/2024/09/RESOLUCION-DINAVISA-N%C2%B0226.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    3

    Max

    6

    Notes
    • 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.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    ivd-national-and-anexo-i

    Class Name

    Productos para diagnóstico de uso in vitro — elaboración nacional y países incluidos en el Anexo I

    Risk Level

    medium

    Pathway

    Registro Sanitario under Resolución DINAVISA N° 266/2022 on the general dossier of Arts. 4 and 5

    Official Timeline
    Min

    30

    Max

    30

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Resolución DINAVISA N° 266/2022, Arts. 6, 7 y 15 — plazos de expedición del registro sanitario de productos para diagnóstico de uso in vitro y su vigencia

    Url

    https://dinavisa.gov.py/wp-content/uploads/2023/08/Resolucion-DINAVISA-N-266-22.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    4

    Notes
    • 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.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    ivd-made-outside-anexo-i-but-registered-in-anexo-i

    Class Name

    Productos para diagnóstico de uso in vitro — elaborados fuera del Anexo I pero registrados y comercializados en un país del Anexo I

    Risk Level

    medium

    Pathway

    Registro Sanitario under Resolución DINAVISA N° 266/2022, filing additionally the current Constancia de Registro Sanitario and Certificado de Libre Venta from the Annex I country

    Official Timeline
    Min

    45

    Max

    45

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Resolución DINAVISA N° 266/2022, Arts. 6, 7 y 15 — plazos de expedición del registro sanitario de productos para diagnóstico de uso in vitro y su vigencia

    Url

    https://dinavisa.gov.py/wp-content/uploads/2023/08/Resolucion-DINAVISA-N-266-22.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    3

    Max

    6

    Notes
    • Art. 6 second paragraph: 45 business days for products manufactured in countries not contemplated in Annex I but registered and commercialised in a country of that annex.
    • The applicant must add the Constancia de Registro Sanitario and the Certificado de Libre Venta in force in the Annex I country at the time of filing, over and above the Arts. 4 and 5 documents.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    ivd-imported-outside-anexo-i

    Class Name

    Productos para diagnóstico de uso in vitro — importados de países fuera del Anexo I

    Risk Level

    high

    Pathway

    Registro Sanitario under Resolución DINAVISA N° 266/2022 for imports from countries not included in Annex I

    Official Timeline
    Min

    120

    Max

    120

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Resolución DINAVISA N° 266/2022, Arts. 6, 7 y 15 — plazos de expedición del registro sanitario de productos para diagnóstico de uso in vitro y su vigencia

    Url

    https://dinavisa.gov.py/wp-content/uploads/2023/08/Resolucion-DINAVISA-N-266-22.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    6

    Max

    12

    Notes
    • Art. 7 fixes 120 business days for imported IVDs from countries outside Annex I. The numeral and the period are legible; the middle of the sentence on the scanned original is obscured by the signature stamp, so the wording of the qualification is taken from the article's structure rather than quoted verbatim.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    ivd-class-iv-simplified-route

    Class Name

    Productos para diagnóstico de uso in vitro Clases II, III y IV — Proceso Simplificado de Registro Sanitario (PSR)

    Risk Level

    highest

    Pathway

    Simplified registration under Resolución DINAVISA N° 44/2024 (Art. 7: classes II, III and IV) for IVDs already authorised and commercialised by a PAHO/WHO reference authority, an IMDRF Management Committee member authority, or an authority with a bilateral agreement with DINAVISA

    Official Timeline
    Min

    15

    Max

    15

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    Resolución DINAVISA N° 44/2024, Arts. 2 y 7 — Proceso Simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro

    Url

    https://dinavisa.gov.py/wp-content/uploads/2024/04/Resolucion-DINAVISA-44.24.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    2

    Notes
    • Resolución DINAVISA N° 44/2024 Art. 2: 'La DINAVISA contará con un plazo de 15 (quince) días hábiles para validar la documentación requerida y expedirse al respecto. Transcurrido el plazo y no habiendo informe alguno de la DINAVISA, la solicitud quedará aproba[da]' — approval follows by positive silence.
    • Objections raised during validation may be answered only once, and the route does not apply to the cases of Resolución DINAVISA N° 266/2022 Arts. 13 and 16.
    • DINAVISA retains in-situ inspection, suspension and cancellation powers, so the shorter clock is not a lighter substantive standard.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

Expedited Pathways
  • Name

    Proceso simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro

    Description

    Class II, III and IV IVDs (Res. 44/2024 Art. 7) already authorised and commercialised by a recognised reference authority are validated in 15 business days with approval by positive silence, instead of the 30, 45 or 120 business days of the ordinary IVD route.

    Timeline Reduction

    From 30-120 business days down to 15 business days

    Eligibility
    • Product classified as class II, III or IV under Resolución DINAVISA N° 266/2022 Art. 9
    • Current authorisation and commercialisation in a country regulated by a PAHO/WHO reference regulatory authority, by an IMDRF Management Committee member authority, or by an authority with a bilateral agreement with DINAVISA
    • The foreign registration must correspond specifically to the same product being registered in Paraguay
  • Name

    Proceso simplificado de Registro Sanitario for class II-IV devices

    Description

    Resolución DINAVISA N° 226/2024 Art. 8(a) submits a class II, III or IV device already authorised by an authority of a country on the Listado Anual Oficial to a 45-business-day evaluation of items b), c), d), g) and h) of Art. 6 instead of the 120-business-day integral analysis.

    Timeline Reduction

    From 120 business days to 45 business days

    Eligibility
    • Device classified by DINAVISA as class II, III or IV
    • Prior authorisation by a regulatory authority of a country on the Listado Anual Oficial emitted under Ley N° 7256/2024 Art. 3, or by an authority with a published bilateral recognition agreement
    • All Art. 6 requirements still filed
Prior Approvals
  • Authority

    FDA 510(k)/PMA

    Accepted

    No

    Benefit

    The US FDA is named in the Listado Anual Oficial (Resolución DINAVISA N° 182/2026), but every published entry of that list states an Alcance of medicamentos and/or vacunas, so the FDA authorisation does not by itself qualify a device for the simplified route; it remains useful as dossier evidence under Art. 6.

  • Authority

    EU CE marking / EU notified body certificate

    Accepted

    No

    Benefit

    The European Commission (DG SANTE), EMA and EU national authorities appear in the Listado Anual Oficial with an Alcance of medicamentos and vacunas; a CE certificate is accepted as quality-system evidence under Art. 6(a) but does not replace Paraguayan registration.

  • Authority

    PAHO/WHO reference authority or IMDRF Management Committee member authority

    Accepted

    Yes

    Benefit

    Operative for class II, III and IV IVDs, which enter the Proceso Simplificado de Registro Sanitario under Resolución DINAVISA N° 44/2024 with a 15-business-day validation and approval by positive silence.

Key Requirements
  • File the application in the DINAVISAPy platform: the responsible técnico declares the device's class there (Resolución DINAVISA N° 226/2024 Art. 4) and the declared class cannot be changed once the notification or certificate is issued.
  • Assemble the dossier items of Resolución DINAVISA N° 226/2024 Art. 6 — including the manufacturer's GMP certificate or equivalent and the finished-product quality-control or conformity certificate — for every class II, III and IV registration.
  • Hold a Paraguayan legal representative or habilitated importer registered with DINAVISA before filing; a foreign manufacturer cannot hold the registration directly.
  • Renew the registration within the 120-business-day window before expiry: a device registration runs ten years under Res. 226/2024 Art. 10 and an IVD registration five years under Res. 266/2022 Art. 15.
  • File a Type II modification for any change to data affecting the device's identity, safety or performance, and keep the registration current while a modification is pending (Res. 226/2024 Art. 14).
Local Rep Required

Yes

Local Rep Name

Representante legal / importador habilitado ante la DINAVISA

Mdsap Accepted

No

Mdsap Benefit

MDSAP is not recognised. An ISO 13485 certificate or an equivalent GMP certificate from the manufacturer is accepted as quality-system evidence under Resolución DINAVISA N° 226/2024 Art. 6(a).

Registration Validity

10 years for devices — both the Notificación Sanitaria Obligatoria and the Certificado de Registro Sanitario (Res. 226/2024 Art. 10); 5 years for IVDs (Res. 266/2022 Art. 15)

Last Updated

2026-09-16

Verification Status

partially-verified

Official Sources
  • Title

    Resolución DINAVISA N° 226/2024, Arts. 9, 10, 11 y 14 — plazos del Proceso simplificado e integral, validez, renovación y modificaciones del registro sanitario de dispositivos médicos

    Url

    https://dinavisa.gov.py/wp-content/uploads/2024/09/RESOLUCION-DINAVISA-N%C2%B0226.pdf

    Accessed Date

    2026-09-16

  • Title

    Resolución DINAVISA N° 266/2022, Arts. 6, 7 y 15 — plazos de expedición del registro sanitario de productos para diagnóstico de uso in vitro y su vigencia

    Url

    https://dinavisa.gov.py/wp-content/uploads/2023/08/Resolucion-DINAVISA-N-266-22.pdf

    Accessed Date

    2026-09-16

  • Title

    Resolución DINAVISA N° 44/2024, Arts. 2 y 7 — Proceso Simplificado de Registro Sanitario (PSR) para productos para diagnóstico de uso in vitro

    Url

    https://dinavisa.gov.py/wp-content/uploads/2024/04/Resolucion-DINAVISA-44.24.pdf

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by DINAVISA. Appoint a Representante legal / importador habilitado ante la DINAVISA.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to DINAVISA including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    DINAVISA reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. DINAVISA may issue questions.

    Duration

    45 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, DINAVISA issues Paraguay market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Paraguay fees →
Jurisdiction Id

paraguay

Country

Paraguay

Country Code

PY

Authority

DINAVISA

Low Risk Local
Min

1170770

Max

1756155

Currency

PYG

Per Product

No

High Risk Local
Min

2926925

Max

3512310

Currency

PYG

Per Product

No

Details
  • Id

    device-family-registration-class-i-national

    Item

    Registro de Familia de Dispositivos médicos, materiales cortopunzantes y equipos de protección individual — Clase I Nacional

    Currency

    PYG

    Amount Local

    1170770

    Amount Local Formatted

    PYG 1.170.770

    Frequency

    Per family registration

    Notes

    Tariff code 480-283: 10 jornales at the jornal mínimo of PYG 117.077.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    device-family-registration-class-i-imported

    Item

    Registro de Familia de Dispositivos médicos — Clase I Importado

    Currency

    PYG

    Amount Local

    1756155

    Amount Local Formatted

    PYG 1.756.155

    Frequency

    Per family registration

    Notes

    Tariff code 480-287: 15 jornales.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    device-family-registration-class-ii-national

    Item

    Registro de Familia de Dispositivos médicos — Clase II Nacional

    Currency

    PYG

    Amount Local

    1756155

    Amount Local Formatted

    PYG 1.756.155

    Frequency

    Per family registration

    Notes

    Tariff code 480-291: 15 jornales.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    device-family-registration-class-ii-imported

    Item

    Registro de Familia de Dispositivos médicos — Clase II Importado

    Currency

    PYG

    Amount Local

    2341540

    Amount Local Formatted

    PYG 2.341.540

    Frequency

    Per family registration

    Notes

    Tariff code 480-295: 20 jornales.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    device-family-registration-class-iii-national

    Item

    Registro de Familia de Dispositivos médicos — Clase III Nacional

    Currency

    PYG

    Amount Local

    2341540

    Amount Local Formatted

    PYG 2.341.540

    Frequency

    Per family registration

    Notes

    Tariff code 480-299: 20 jornales.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    device-family-registration-class-iii-imported

    Item

    Registro de Familia de Dispositivos médicos — Clase III Importado

    Currency

    PYG

    Amount Local

    2926925

    Amount Local Formatted

    PYG 2.926.925

    Frequency

    Per family registration

    Notes

    Tariff code 480-303: 25 jornales.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    device-family-registration-class-iv-national

    Item

    Registro de Familia de Dispositivos médicos — Clase IV Nacional

    Currency

    PYG

    Amount Local

    2926925

    Amount Local Formatted

    PYG 2.926.925

    Frequency

    Per family registration

    Notes

    Tariff code 480-307: 25 jornales.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    device-family-registration-class-iv-imported

    Item

    Registro de Familia de Dispositivos médicos — Clase IV Importado

    Currency

    PYG

    Amount Local

    3512310

    Amount Local Formatted

    PYG 3.512.310

    Frequency

    Per family registration

    Notes

    Tariff code 480-311: 30 jornales. This is the highest device registration tariff in the table.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    device-family-renewal-class-iv-imported

    Item

    Renovación de Registro de Familia de Dispositivos médicos — Clase IV Importado

    Currency

    PYG

    Amount Local

    3278156

    Amount Local Formatted

    PYG 3.278.156

    Frequency

    Per renewal, every 10 years

    Notes

    Tariff code 480-312: 28 jornales. Renewal of a device registration is charged at the registration rate less two jornales for this class.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    device-family-modification

    Item

    Modificación de Registro de Familia de Dispositivos médicos, materiales cortopunzantes y equipos de protección individual

    Currency

    PYG

    Amount Local

    585385

    Amount Local Formatted

    PYG 585.385

    Frequency

    Per modification

    Notes

    Charged at 5 jornales for every class and origin: tariff codes 480-285 (class I national), 480-289 (class I imported), 480-293 (class II national), 480-297 (class II imported), 480-301 (class III national), 480-305 (class III imported), 480-309 (class IV national) and 480-313 (class IV imported).

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    ivd-registration-national

    Item

    Registros Sanitarios Nuevos/Renovación de Producto para diagnósticos de uso in vitro, de origen nacional

    Currency

    PYG

    Amount Local

    2107386

    Amount Local Formatted

    PYG 2.107.386

    Frequency

    Per product, new registration or renewal

    Notes

    Tariff code 480-443: 18 jornales, under the ARANCELES PARA PRODUCTOS IN VITRO section of the same table.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    ivd-registration-imported

    Item

    Registros Sanitarios Nuevos/Renovación de Producto para diagnósticos de uso in vitro, de origen importado

    Currency

    PYG

    Amount Local

    2341540

    Amount Local Formatted

    PYG 2.341.540

    Frequency

    Per product, new registration or renewal

    Notes

    Tariff code 480-444: 20 jornales. IVD registrations run for five years under Resolución DINAVISA N° 266/2022 Art. 15.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    device-import-authorisation-registered-firm

    Item

    Autorización para importación de Dispositivos Médicos — para empresas registradas

    Currency

    PYG

    Amount Local

    234154

    Amount Local Formatted

    PYG 234.154

    Frequency

    Per import authorisation

    Notes

    Tariff code 480-174: 2 jornales; available to firms already registered with DINAVISA.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

  • Id

    device-importer-opening-inspection

    Item

    Inspección para aperturas, traslado de representantes, importadoras, exportadoras, distribuidoras, depósitos, comercializadoras, fraccionadoras, envasadoras y laboratorios de producción de dispositivos médicos

    Currency

    PYG

    Amount Local

    4097695

    Amount Local Formatted

    PYG 4.097.695

    Frequency

    Per inspection

    Notes

    Tariff code 480-317: 35 jornales; charged to the importing or distributing firm, not per product. The comparable GMP/BPM inspection is 480-322 at 33 jornales within 50 km of Asunción.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Source Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Verified On

    2026-09-16

Notes
  • Every amount is a multiple of the jornal mínimo of PYG 117.077 printed in the table; the jornal count and the resulting guarani amount are both published, so each figure is exact rather than derived.
  • Device fees are charged per Registro de Familia, not per model: a family registration covers the group of models accepted as one family.
  • Class I device notifications and certificates are renewed through the simplified automatic-renewal procedure of Resolución DINAVISA N° 226/2024 Art. 12, which is charged at the renewal tariff codes (for example 480-284, 8 jornales, for a class I national family).
  • The table is published as the DINAVISA 2026-2027 tariff schedule; the document itself prints no date or adopting resolution number (the file sits under a July 2026 upload path), so no effective date is asserted.
  • CONATEL's homologation fee is not in this table: Resolución Directorio N° 588/2009 Art. 27 sets it at the amount established by a Decreto del Poder Ejecutivo and publishes no figure, and laboratory test costs are borne by the applicant.
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    TABLA DE ARANCELES DE LA DIRECCIÓN NACIONAL DE VIGILANCIA SANITARIA — ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS y ARANCELES PARA PRODUCTOS IN VITRO (2026-2027)

    Url

    https://dinavisa.gov.py/wp-content/uploads/2026/07/ARANCELES-DINAVISA-2026-2027.pdf

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Paraguay certifications →
Slug

paraguay

Market

Paraguay

Confidence

high

Schemes
  • Id

    dinavisa-device-dossier-safety-and-quality-evidence

    Name

    DINAVISA device registration dossier — quality and finished-product conformity evidence

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    There is no separate Paraguayan electrical-safety or EMC certificate for a medical device: the evidence is filed inside the sanitary-registration dossier. Resolución DINAVISA N° 226/2024 Art. 6(a) requires the manufacturer's Good Manufacturing Practice certificate or its equivalent — an ISO 13485, CE, UL or FDA-issued quality certificate — and Art. 6(e) requires a quality-control certificate for the finished product covering every test that guarantees the device's functionality, quality and safety under the applicable standards, or a product conformity certificate. The dossier runs through the DINAVISAPy platform, and DINAVISA retains in-situ inspection and cancellation powers.

    Source Urls
    • https://dinavisa.gov.py/wp-content/uploads/2024/09/RESOLUCION-DINAVISA-N%C2%B0226.pdf
    Source Binding

    reviewed

  • Id

    conatel-homologation-category-ii-radio-equipment

    Name

    CONATEL homologation — equipment that makes use of the radioelectric spectrum

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Resolución Directorio N° 588/2009 Art. 2.1 defines Category II as telecommunications equipment that makes use of the radioelectric spectrum, antennas included, at any effective radiated power, and Art. 6 prohibits the commercialisation, installation and operation of equipment falling in Categories I, II or III without prior homologation by CONATEL. The applicant obtains a Certificado de Homologación against the applicable technical standard; Art. 12 caps its validity at five years, and Art. 3 allows test reports and certification from duly accredited foreign conformity-assessment bodies while no Paraguayan accreditation body exists for this purpose. A medical device with a radio transmitter (for example a telemetry or Wi-Fi enabled monitor) therefore needs a CONATEL homologation in addition to its DINAVISA registration.

    Source Urls
    • https://www.conatel.gov.py/conatel/wp-content/uploads/2019/09/2009-rd-588-homologacion.pdf
    • https://www.conatel.gov.py/homologacion/
    Source Binding

    reviewed

  • Id

    conatel-homologation-category-i-network-equipment

    Name

    CONATEL homologation — equipment connectable to the public telecommunications network

    Category

    Telecom Network Attachment

    Status

    Mandatory If Feature

    Object

    Terminal Equipment Connected To Public Networks

    Note

    Resolución Directorio N° 588/2009 Art. 2.1 Category I covers telecommunications equipment intended to connect, directly or indirectly, to the public telecommunications networks or through a network termination, and Art. 6 makes prior CONATEL homologation a condition of commercialisation, installation and operation. Art. 7 adds an express manufacturer, importer or commercialiser declaration on whether equipment capable of connecting to a public network is in fact intended for that purpose: absent the declaration the equipment is presumed to be destined for public-network connection. Equipment that reaches the public network over a radio link falls in the same regime as Category II.

    Source Urls
    • https://www.conatel.gov.py/conatel/wp-content/uploads/2019/09/2009-rd-588-homologacion.pdf
    • https://www.conatel.gov.py/homologacion/
    Source Binding

    reviewed

  • Id

    conatel-rf-emc-declaration-no-homologation

    Name

    CONATEL radiofrequency-emissions limits — declaration instead of homologation

    Category

    emc

    Status

    Evidence Only No Separate Certificate

    Object

    Rf Emitting Equipment Outside Homologation Categories

    Note

    For equipment outside Category 2.1 that can nonetheless generate radiofrequency radiation or interference to telecommunications services, Resolución Directorio N° 588/2009 Art. 2.3(b) states expressly that homologation is not required, but makes the manufacturer, representative or distributor responsible for ensuring that radiated and conducted emissions stay within the tolerable limits of the applicable specific standards and for keeping the corresponding test reports available for CONATEL review. The electromagnetic-compatibility requirements must also be declared by the manufacturer, representative or distributor and included in the equipment's publications — including, as recommended, on the identification plate. This is a documentation duty, not a certificate.

    Source Urls
    • https://www.conatel.gov.py/conatel/wp-content/uploads/2019/09/2009-rd-588-homologacion.pdf
    Source Binding

    reviewed

  • Id

    intn-onm-legal-metrology-regulated-instruments

    Name

    INTN Organismo Nacional de Metrología — model approval, importer registration and periodic verification of regulated measuring instruments

    Category

    Legal Metrology

    Status

    Mandatory If Feature

    Object

    Regulated Measuring Instrument

    Note

    The Organismo Nacional de Metrología of the Instituto Nacional de Tecnología, Normalización y Metrología administers Ley N° 937/82 de Metrología and its Reglamento General, Decreto N° 1988/99. Its published technical regulations include ONM-RTM-03 for clinical liquid-in-glass thermometers and DMLE-RT 04 for digital clinical thermometers, and its department list assigns model approval or homologation of regulated measuring instruments, the register of importers and manufacturers of measuring instruments, and periodic verification to named units — clinical thermometers appearing in both the model-approval and the health-and-safety verification lists, alongside weighing instruments used commercially. A clinical thermometer therefore needs model approval, an importer registration and periodic verification at use site, separate from its DINAVISA registration.

    Source Urls
    • https://intn.gov.py/organismo-nacional-de-metrologia/
    • https://intn.gov.py/onm-departamentos/
    Source Binding

    reviewed

  • Id

    arrn-ionizing-radiation-source-and-equipment-authorisation

    Name

    ARRN prior authorisation for ionizing-radiation sources and generating equipment

    Category

    Ionizing Radiation

    Status

    Mandatory If Feature

    Object

    Ionizing Radiation Generating Equipment

    Note

    Ley N° 5169/2014 Art. 7 provides that without the prior authorisation of the Autoridad Reguladora Radiológica y Nuclear no source may, as applicable, be designed, manufactured, acquired, imported or exported, distributed, sold, possessed, installed, used or operated, and Art. 8(d) gives the ARRN the power to authorise, suspend or revoke authorisations for all the activities of Art. 5 in respect of radioactive sources or ionizing-radiation generating equipment. The ARRN publishes the corresponding procedures and forms, including an inscription certificate for import and export and a specific procedure for importing ionizing-radiation sources. X-ray, CT and radiotherapy equipment therefore needs an ARRN authorisation on top of DINAVISA registration, and IVD radioassay kits carry the same label warning under Resolución DINAVISA N° 266/2022.

    Source Urls
    • https://www.bacn.gov.py/leyes-paraguayas/2945/crea-la-autoridad-reguladora-radiologica-y-nuclear
    • https://www.arrn.gov.py/notas-formularios-requisitos/
    Source Binding

    reviewed

Official Sources
  • Authority

    DINAVISA

    Topic

    medical-device classification, registration requirements, review clocks and validity (Resolución DINAVISA N° 226/2024)

    Url

    https://dinavisa.gov.py/wp-content/uploads/2024/09/RESOLUCION-DINAVISA-N%C2%B0226.pdf

  • Authority

    CONATEL

    Topic

    Reglamento para la Homologación de Equipos y Aparatos de Telecomunicaciones (Resolución Directorio N° 588/2009)

    Url

    https://www.conatel.gov.py/conatel/wp-content/uploads/2019/09/2009-rd-588-homologacion.pdf

  • Authority

    CONATEL

    Topic

    homologation procedure, required documents and list of homologated equipment

    Url

    https://www.conatel.gov.py/homologacion/

  • Authority

    INTN — Organismo Nacional de Metrología

    Topic

    legal metrology framework (Ley N° 937/82, Decreto N° 1988/99) and reglamentos técnicos metrológicos including clinical thermometers

    Url

    https://intn.gov.py/organismo-nacional-de-metrologia/

  • Authority

    INTN — Organismo Nacional de Metrología

    Topic

    metrology department functions: model approval of regulated instruments, importer register and periodic verification

    Url

    https://intn.gov.py/onm-departamentos/

  • Authority

    ARRN

    Topic

    Ley N° 5169/2014 — crea la Autoridad Reguladora Radiológica y Nuclear (full text, BACN)

    Url

    https://www.bacn.gov.py/leyes-paraguayas/2945/crea-la-autoridad-reguladora-radiologica-y-nuclear

  • Authority

    ARRN

    Topic

    authorisation procedures, forms and requirements, including import of ionizing-radiation sources

    Url

    https://www.arrn.gov.py/notas-formularios-requisitos/

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