Paraguay medical device regulations

DINAVISA's tariff table for 2026–2027: sixteen sections of code, concept, number of jornales, the jornal mínimo and the resulting total, covering the regional offices, registros, despachos, price fixing and updating, quality control, publicity, biofarmacia y bioequivalencia, biológicos, habilitación y establecimientos, inspection, the legal affairs directorate, cáñamo-derived products, in-vitro products, the research directorate and food products. The section that matters to this market is "ARANCELES PARA REGISTROS DE DISPOSITIVOS MEDICOS", which prices the device registration step; it is a fee schedule, so it evidences what the step costs and not what it requires. The document states no publication date and its own heading covers two calendar years, so none is recorded. Each section heading is a block and its rows are preserved as the PDF lays them out, so the columns read across each section rather than per row.

Resolución S.G. N° 554/2024, Asunción, 16 de setiembre de 2024, issued by the Ministra de Salud Pública y Bienestar Social, which abrogates Resolución S.G. N° 669 of 19 October 2016. Res. 669/2016 was the instrument that reglamentaba el Artículo 4° inciso b) de la Ley N° 4659/12 and, in the words of this resolution's own title, thereby established "normas para la obtención del registro sanitario de productos considerados dispositivos médicos, materiales cortopunzantes y equipos de protección individual" — that is, it was Paraguay's device registration norm of 2016. (Round 207's triage records the instrument that now sets the requirements for obtaining a device marketing authorisation as Resolución DINAVISA N° 226/2024, published only as a 41-page image-only scan; neither it nor 669/2016 is ingested here.) Two articles only: the abrogation, and the instruction to communicate and archive. The exordio states the reason (Nota DINAVISA N° 1533 of 12 September 2024, and the reorganisation that followed Ley N° 6788/2021 giving DINAVISA autonomy under Resolución DINAVISA N° 98 of 7 May 2024), and names the constitutional and statutory basis in Ley N° 836/80 and Ley N° 6788/2021. This is the whole of what this market's declared documents yield on the registration requirement, and it is a repeal, not a requirement: a reviewer should read this row as evidence that Paraguay withdrew its device registration norm in September 2024 and not as evidence of what an applicant must now file. The repealed instrument is not ingested here and is not a row in this corpus. The PDF carries a heavy, noisy embedded OCR text layer — the running letterhead is unreadable and the article numbering prints the ordinal sign as a zero ("Artícrlo 10" for "Artículo 1°", "Artículo 20." for "Artículo 2°"). The text is ingested exactly as the authority published it; the block labels read Artículo 1 and Artículo 2, which is what the printed pages mean.