Paraguay Medical Device Regulation 2026: Ley 6788/2021 and DINAVISA Autonomy

1. Key takeaways

1. Ley N° 6788/2021 establishes the competence, powers and organizational structure of DINAVISA, declaring that the directorate possesses administrative autonomy (autonomía administrativa), financial self-sufficiency (autarquía) and its own assets (patrimonio propio), together with full legal capacity to act in both public and private spheres. This triple formula is what distinguishes DINAVISA from a mere department of the ministry: it can own property, collect its own revenue and answer for its own budget.
2. Article 5, inc. b) of that law is the direct authorization under which DINAVISA issues its own technical regulations, guidelines and good practice documents; it is also the source of legality for Resolución N° 226/2024. In other words, the 2024 resolution does not rest on a ministerial delegation but on a statutory power that the directorate exercises in its own name.
3. Ley N° 6788/2021 was subsequently amended by Ley N° 7361/2024; later administrative regulations, such as Decreto N° 2942/2024, cite in their recitals Article 5 of Ley N° 6788/2021 as amended by Ley N° 7361/2024, which makes the amended formulation the standard reference in all downstream documents.
4. Autonomous status produces one immediate consequence: fees may be graded and set by DINAVISA itself (Article 35 of Resolución N° 226/2024), and the fee schedule is adjusted over the years, so amounts quoted in one cycle cannot be assumed to hold in the next.

2. Legal basis

3. Expert insights

Insight 1: autonomy does not mean discretion; it means that the rulemaking, fee and inspection loop is self-contained. For a regulator with financial self-sufficiency, fee revenue and institutional operations are directly linked, so annual adjustments to the fee schedule carry their own internal momentum. At the same time, because the authority does not need case-by-case ministerial approval to regulate, technical requirements can be updated faster than external observers expect. This dynamic explains why, between 2024 and 2026, parallel regulatory renewals occurred across devices, medicines and cosmetics rather than in a single product line. For planning purposes, the practical reading is that a quiet year at DINAVISA is an exception rather than a norm, and monitoring must be continuous rather than event-driven.

Insight 2: the existence of the amending law (Ley N° 7361/2024) signals that citations must be written in full. Administrative regulations cite Article 5 of Ley N° 6788/2021 as amended by Ley N° 7361/2024, which confirms that the content of Article 5 has been modified. When companies reference DINAVISA powers in contracts, a citation limited to the original provision may create version discrepancies during textual comparison, and the counterparty may exploit the ambiguity. The safe drafting habit is to include the amending law every time, and to re-check the citation whenever an old template is reused for a new file, because outdated references survive longest inside recycled boilerplate. A one-line internal style rule fixing the citation format across departments eliminates the problem at its source.

Insight 3: autonomous status also raises the seriousness of administrative procedures. Article 31 of Resolución N° 226/2024 states that false, tampered or untruthful documents trigger liability under Article 243 of the Paraguayan Penal Code, and responsibility falls personally on the applicant and on the technical responsible person. An autonomous institution that issues its own certificates has a strong institutional incentive to keep its register clean, so documentary integrity should be treated as a non-negotiable gate rather than a best-effort target. Because the named individuals bear the exposure personally, resignation or staff turnover does not extinguish liability for declarations already signed, which makes the record-keeping around signatures part of the compliance system itself. Compliance owners should map every declaration in their portfolio to the person who signed it, so the trail survives personnel changes.

4. Practical recommendations

1. In all external documents citing DINAVISA powers, use the full formulation: Article 5, inc. b) of Ley N° 6788/2021, as amended by Ley N° 7361/2024, including the amendment reference in contracts, powers of attorney and regulatory submissions alike, so that no document in the file chain can be attacked for citing a superseded text.
2. In budget models, list official fees as a separate line item settled according to the official fee schedule in force, and reserve headroom for annual adjustments rather than fixing amounts in project budgets, especially for multi-year launch programs that will span more than one fee cycle.
3. Ensure the technical responsible person (Regente) is fully informed of personal liability under Article 31 of the resolution and Article 243 of the Penal Code, and build an internal review checkpoint into the signature workflow before any declaration is filed, so that no declaration leaves the company without a second pair of eyes on its factual content.
4. Monitor the news section of the DINAVISA website: for an autonomous institution, institutional changes are usually published on the official site first and only later consolidated in the official gazette, so early indicators appear there and early readers gain preparation time that late readers do not have.

5. Verification checklist

• □ Citations written in full as Article 5, inc. b) of Ley N° 6788/2021, as amended by Ley N° 7361/2024
• □ Confirmed that fee-setting power is found in Article 35 of Resolución N° 226/2024
• □ Quotations contain no fixed official fee amounts (practical estimate)
• □ Technical responsible person informed of liabilities under Article 31 and Article 243 of the Penal Code
• □ Subscribed to updates from the news section of the DINAVISA website

Regulatory information verified as of October 29, 2026.

GRZAN provides medical device registration support in Paraguay for manufacturers, importers and authorized representatives. For inquiries, contact info@grzanglobal.com.