Paraguay Medical Device Regulation 2026: Ley 1119/97 and the Health Code Framework

1. Key takeaways

1. Ley N° 1119/97 (October 10, 1997) regulates, for human medicines, active pharmaceutical ingredients, chemical products, reagents and other products used in human medical care, as well as products regarded as cosmetics, the manufacture, formulation, movement, quality control, prescription, distribution, dispensing, commercialization, import and export, storage, rational use, price system, information, advertising, evaluation, authorization and registration. The breadth of this catalogue is the reason the law keeps appearing in files that look, at first sight, purely device-related. The overlap matters most for combination items, where the same physical product may satisfy two definitions and the filing must commit to one regime.
2. The dedicated legal authority for device sanitary registration is Article 4, inc. b) of Ley N° 4659/12; the two laws may overlap in categories such as reagents and chemical products, so attribution must be determined case by case, product by product, rather than assumed at the portfolio level. In a portfolio review, the fastest screen is to list every SKU whose description contains a reagent or chemical component and run the attribution test on those first.
3. Article 3 of the Health Code, Ley N° 836/80, establishes the Ministry of Public Health and Social Welfare (MSPBS) as the highest health authority, and Article 4 provides that health powers are exercised through the MSPBS; this is the constitutional-style foundation on which the whole sanitary apparatus, including DINAVISA, ultimately rests.
4. Later administrative regulations cite both lines of authority simultaneously: for example, Decreto N° 2942/2024 cites Article 39 of Ley N° 1119/97 together with Article 5 of Ley N° 6788/2021 as amended by Ley N° 7361/2024, a dual citation that neatly displays which statutory family the instrument belongs to.

2. Legal basis

3. Expert insights

Insight 1: the boundary between superior laws decides which regime takes a borderline product. The list in Ley N° 1119/97 includes reagents and chemical products, while in vitro diagnostic reagents are at the same time objects of device regulation. This textual overlap produces attribution disputes in practice, and the point of resolution remains the device definition under Article 4, inc. b) of Ley N° 4659/12 and the current resolution. A documented attribution analysis at the start of the project is far cheaper than a mid-course discovery that the product sits under the wrong regime and the prepared dossier targets the wrong authority.

Insight 2: the Health Code provides organizational legitimacy, not product requirements. Articles 3 and 4 answer the question of whether the MSPBS has power over health matters; the rulemaking power of DINAVISA comes separately from Article 5, inc. b) of Ley N° 6788/2021. Three levels, code, organizational law and product law, each do their own work, and citations must not mix them. Communications that attribute device technical requirements to ministerial policy blur these levels and weaken the precision of regulatory arguments. When an authority letter is answered, answering at the right level, with the right instrument, is often what decides whether the exchange closes in one round or several. Internal trainings should use real correspondence examples to show the difference, because the distinction is easy to state and easy to forget under deadline pressure. The habit also shortens authority responses, because correct attribution rarely generates follow-up questions.

Insight 3: the way an administrative regulation cites its legal authority is a shortcut for judging its scope. Whether an administrative instrument cites Article 39 of Ley N° 1119/97 or Article 4, inc. b) of Ley N° 4659/12 indicates whether it governs cosmetic categories or device categories. This is exactly why Decreto N° 2942/2024 does not apply to devices: its source of authority sits on the cosmetics line. Reading recitals before reading requirements saves review time and prevents rules from being imported into the wrong product dossier. Where the recitals cite both lines, the operative articles usually reveal the true scope, and the table entry should note both citations. A quarterly review of new decrees and their recitals keeps the table current, and the review itself should have a named owner. This habit costs minutes per regulation and saves hours per dispute.

4. Practical recommendations

1. For borderline products in the reagent, chemical product or disinfectant categories, complete an attribution determination and archive it before starting dossier preparation; do not begin assembly before the determination is made, since every document written under the wrong regime has to be rewritten rather than amended.
2. In external communications, distinguish the MSPBS system from the powers of DINAVISA, and avoid equating ministerial policy with device technical requirements, so arguments are addressed to the institution that actually holds the power being invoked.
3. Build a cross-reference table of legal sources and product categories, and use the recitals of administrative regulations to infer their scope of application, updating the table whenever a new decree or resolution is published on the official site.
4. For requirements touching prices, advertising and promotional activities, note that their legal source may lie on the line of Ley N° 1119/97, and confirm the applicable path separately from device registration work, since marketing teams often touch these requirements without passing through the regulatory function at all.

5. Verification checklist

• □ Attribution determination completed and archived for borderline products (reagents, chemicals, disinfectants)
• □ External documents distinguish MSPBS from DINAVISA powers
• □ Cross-reference table of legal sources and applicable categories established
• □ Legal source line of every cited administrative regulation confirmed
• □ Separate confirmation path established for price and advertising requirements
• □ Recital review of new administrative regulations scheduled quarterly
• □ Marketing and pricing requirements routed for regulatory confirmation before publication

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.