Paraguay Medical Device Post-Market Compliance: Sanitary Risk Assessment and Sanction Discretion Methodology 2026

1. Key takeaways

1. DINAVISA has adopted a new methodology for sanitary risk assessment and sanction discretion, used to grade the administrative measures applied in violation scenarios, in force since May 2026.
2. Structure of the method: it evaluates eight variables related to the product, the premises and the risk exposure, computes an index, and assigns the violation to 3 tiers of low, medium or high risk.
3. The regulatory measures available include suspension of operating activities, closure of premises, isolation, confiscation or destruction of products, withdrawal from the market, suspension of the sanitary registration, initiation of administrative proceedings, and fines of up to 1,000 daily wages (jornales diarios).
4. The mandatory scope expressly includes human medicines, medical devices and dental devices, dietary supplements, plant-based medicines and in vitro diagnostic products.

Because the index is fed by premises conditions as well as product characteristics, storage and record-keeping practices at the local holder contribute directly to the score, extending compliance responsibility beyond the technical file and into the physical operation of the Paraguay partner.

2. Legal basis

The new methodology operates alongside, not instead of, the existing sanction architecture. Article 30 of Resolution 226/2024 already routes violations to the sanction regime in force at DINAVISA; the 2026 methodology determines how the measures of that regime are graded in each concrete case. Because the resolution number of the new method is pending verification against the official DINAVISA publication, companies should confirm the instrument and its full text directly with the authority before relying on any secondary description of its variables.

The grading logic also explains the composition of the measure list. Measures ascend from corrective interventions, such as isolation or withdrawal of specific products, to structural ones, such as closure of premises and suspension of the sanitary registration, and finally to fines expressed in daily wages, up to 1,000 jornales diarios. Because the index determines the tier, two files presenting the same violation but different variable profiles can end at different rungs of that ladder, which is precisely what makes the eight variables worth mapping in advance.

3. Expert insights

Insight one: the method moves sanctioning from qualitative judgment to quantitative grading. Eight variables across the three dimensions of product, premises and risk exposure combine into a single index, which then maps onto a tier of measures. For certificate holders the implication is that the same category of violation can produce outcomes an order of magnitude apart depending on the risk level of the product and the condition of the premises: a labeling violation on a high-risk device will not be treated like the same violation on a low-value consumable. Compliance resourcing should therefore be weighted by the risk profile of the portfolio rather than spread evenly, because the authority itself now grades cases that way.

Insight two: the entry of suspension of the sanitary registration into the measure list is the largest single exposure for certificate holders. The measure suspensión de registros sanitarios cuts off the legal ability to sell outright. Stacked on top of the suspension mechanism of Article 15, it creates two independent paths to a shutdown of sales: one triggered by unreported changes through a de oficio suspension, and one triggered by graded violation risk through suspension of the registration itself. A company can, in principle, face both for related conduct, which makes change discipline and vigilance discipline mutually reinforcing defenses.

Insight three: the baseline of compliance expected from existing certificate holders rises. The mandatory scope includes medical devices, dental devices and IVD products, which means that after May 2026 every Paraguay certificate holder operates inside this discretion framework. Historical blemishes accumulated before the method entered into force, such as unreported changes or gaps in vigilance records, carry a higher risk weight under the new grading logic. Cleaning the legacy file is therefore more valuable after May 2026 than it ever was before, because the same defect now feeds a quantitative index that determines the severity of the response.

4. Practical recommendations

1. Conduct an immediate self-assessment across the three dimensions of product, premises and risk exposure, and identify the combinations most likely to be graded as high risk under the new index.
2. Perform a compliance health check of the existing certificate portfolio, prioritizing the cleanup of unreported changes and gaps in vigilance records before they enter a graded assessment.
3. Confirm with the local certificate holder its understanding and preparation for the new method, and allocate corrective responsibilities between the parties in writing.
4. Track the DINAVISA official publication for the resolution number and full text of the methodology, and verify the concrete definitions of the eight variables against the source rather than against summaries.

The pending resolution number is not a reason to postpone preparation. The effective date, the three-tier structure, the measure list and the mandatory scope are already public; only the citation details await the official publication. Companies that map their risk profile now will read the final text faster than those that wait, and the remediation work identified by the self-assessment will be the same regardless of the final citation, so no preparation effort is wasted.

5. Verification checklist

• □ It is confirmed that the new method has been in force since May 2026 and mandatorily covers devices and IVDs
• □ The self-assessment across the three dimensions has been completed
• □ The compliance health check of existing certificates has been completed
• □ The resolution number and full text of the method have been checked with DINAVISA (practical estimate: number pending official confirmation)
• □ Corrective responsibilities have been allocated with the local certificate holder

Regulatory information verified as of October 29, 2026.

GRZAN provides registration and post-market compliance support for medical device manufacturers, importers and authorized representatives in Paraguay. For assistance with sanction risk assessment, remediation or any other regulatory matter, contact info@grzanglobal.com.