Free Paraguay medical device classification tool

What the Paraguay classifier checks

How are medical devices classified in Paraguay?

DINAVISA uses a risk-based framework. Possible classes include IVDs: Clase I — riesgo bajo para la salud individual y riesgo bajo para la salud pública, Clase II — riesgo medio para la salud individual y/o riesgo bajo para la salud pública, Clase III — riesgo elevado para la salud individual y/o riesgo medio para la salud pública, Clase IV — riesgo elevado para la salud individual y riesgo elevado para la salud pública; Medical devices: Clase I, Clase II, Clase III, Clase IV. 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). 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. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.

What information does the Paraguay classifier use?

Current DINAVISA requirements and similar registered products for context. Your result includes an explanation and links to the official sources used.

Is the result an official DINAVISA classification decision?

No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.