Paraguay medical device registration timeline
Source-linked clocksDirección Nacional de Vigilancia Sanitaria (DINAVISA), Ministerio de Salud Pública y Bienestar Social (DINAVISA) review clocks and end-to-end planning ranges, using the 4-class (I, II, III, IV) — intrinsic-risk classes for devices under Resolución DINAVISA N° 226/2024 Anexo I, and by individual and public-health risk for IVDs under Resolución DINAVISA N° 266/2022 Art. 9 classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Clases II, III y IV — Proceso simplificado de Registro Sanitario(Simplified registration under Resolución DINAVISA N° 226/2024 Art. 8(a): the applicant still files every Art. 6 requirement, but DINAVISA re-examines only items b), c), d), g) and h) of Art. 6 rather than the whole dossier) 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.' | 45 working days | 3-6 months | — | Verified |
| Clases II, III y IV — análisis integral del expediente(Integral registration under Resolución DINAVISA N° 226/2024 Art. 8(b): every Art. 6 item is evaluated) 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.' | 120 working days | 6-12 months | — | Verified |
| Dispositivos ya registrados — modificación Tipo II(Post-registration modification filed in DINAVISAPy; Resolución DINAVISA N° 226/2024 distinguishes Type I from Type II modifications) 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. | 45 working days | 3-6 months | — | Verified |
| Productos para diagnóstico de uso in vitro — elaboración nacional y países incluidos en el Anexo I(Registro Sanitario under Resolución DINAVISA N° 266/2022 on the general dossier of Arts. 4 and 5) 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.' | 30 working days | 2-4 months | — | Verified |
| Productos para diagnóstico de uso in vitro — elaborados fuera del Anexo I pero registrados y comercializados en un país del Anexo I(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) 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. | 45 working days | 3-6 months | — | Verified |
| Productos para diagnóstico de uso in vitro — importados de países fuera del Anexo I(Registro Sanitario under Resolución DINAVISA N° 266/2022 for imports from countries not included in Annex I) 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. | 120 working days | 6-12 months | — | Verified |
| Productos para diagnóstico de uso in vitro Clases II, III y IV — Proceso Simplificado de Registro Sanitario (PSR)(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) 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. | 15 working days | 1-2 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Paraguay Medical Device Registration Process
Step-by-step DINAVISA registration process. Total estimated timeline: 3-6 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by DINAVISA. Appoint a Representante legal / importador habilitado ante la DINAVISA.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to DINAVISA including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksDINAVISA reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
45 working daysIn-depth technical assessment of device safety and performance. DINAVISA may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, DINAVISA issues Paraguay market authorization certificate.
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.
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 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.
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
- 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).
Reviewed 2026-09-16. End-to-end totals remain planning estimates.