Paraguay Medical Device Registration 2026: Legal Basis under Ley 4659/12

1. Key takeaways

1. The superior authorization for the Paraguayan device sanitary registration system is Article 4, inc. b) of Ley N° 4659/12, a law whose full title is the law implementing medical safety procedures and risk prevention mechanisms for healthcare professionals and patients. Because the authorization is statutory, the registration obligation does not depend on the survival of any particular subordinate resolution.
2. The repealed Resolución S.G. N° 669/2016 (October 19, 2016) and the current Resolución DINAVISA N° 226/2024 both state in their titles that they were issued under Article 4, inc. b) of Ley N° 4659/12, so the chain of authority is continuous across the 2024 change of regulation, and a certificate issued under the old instrument is not a certificate issued under a different legal system.
3. Article 9 of Ley N° 4659/12 authorizes inspections of healthcare institutions and enterprises engaged in the sale of devices; Article 29 of Resolución N° 226/2024 builds on it to establish powers of on-site inspection and sampling and testing, which means the enforcement powers of the current regime are themselves anchored in a 2012 statute rather than invented by the new resolution.
4. Stable legal authority means that what changed in 2024 was the subordinate procedure, not the system itself: existing certificates and compliance obligations were not interrupted by the change of regulation (Article 34), and companies should plan transitions around renewals rather than around re-registrations.

2. Legal basis

3. Expert insights

Insight 1: continuity of legal authority is the legal foundation for grandfathered certificates remaining valid. Article 34 states expressly that certificates already issued remain valid until their expiry date, and that renewals filed after expiry follow the new regulation. This provision can stand precisely because the old and new procedures share the same root: Article 4, inc. b) of Ley N° 4659/12. The authorization never changed, only the technical requirements were updated. Companies therefore do not need to re-register because of the 2024 change of regulation, but they must close every gap against the new requirements when renewal falls due, and the gap analysis should be scheduled well ahead of the expiry date. Renewal files also benefit from being drafted against the new checklist from the outset, rather than from converting the old structure at the last minute.

Insight 2: Article 9 brings commercial enterprises into the inspection perimeter, so the risk extends beyond the product itself. Article 29 of Resolución N° 226/2024 derives from it the power to inspect premises, and the cost allocation rule is written in hard terms: for products holding a certificate, the registration holder bears the cost; for products without a registration certificate or NSO, the importer or the manufacturer bears the cost. This clause is a substantive constraint on the common practice of testing the market with small trial shipments, because an unregistered batch does not merely risk seizure, it also places the full cost of sampling and testing on the company that brought the product in. For distributors, the same allocation should be mirrored in supply terms so neither side discovers it at the moment of an inspection.

Insight 3: the same provision of legal authority explains why sharps and protective equipment are treated as devices. The title of Resolution 669/2016 already covered sharps and personal protective equipment, and item 22 of the definitions chapter of the current resolution continues to list sharps expressly as medical devices. The title of Resolution 669/2016 already covered sharps and personal protective equipment, and item 22 of the definitions chapter of the current resolution continues to list sharps expressly as medical devices. Product categories that in other markets are managed as occupational safety supplies or consumables are regulated as devices in Paraguay, and classification logic should start from the local definition rather than from the category name used at home. The practical consequence is that a category decision made in another market cannot be imported into a Paraguay file without being re-tested against the definitions chapter of the current resolution. Importers of general consumables should therefore run the determination before the first shipment, not after the first inspection.

4. Practical recommendations

1. When compiling the product list, include sharps, personal protective equipment, device accessories and procedure sets (kits/sets) in the device determination, instead of following the habitual categories used in the home market, and record the reasoning for each inclusion so the determination survives review.
2. Run a renewal impact assessment for every existing certificate, comparing current documentation against the checklist in Article 12, so that gaps are not discovered only inside the 120 business day window before expiry, when the time available for corrective work is already scarce.
3. In agreements with local partners, state expressly which party bears testing costs under Article 29, and make the allocation of sampling and testing expenses a negotiated clause rather than a default assumption that surfaces only when an inspector arrives.
4. Do not schedule trial import shipments of unregistered products: without a certificate or NSO, both the costs and the liabilities fall directly on the importer or the manufacturer under the applicable provisions, and a small exploratory batch can generate a disproportionate compliance and cost exposure.

5. Verification checklist

• □ Product list covers sharps, protective equipment, accessories and kits/sets
• □ Confirmed that existing certificates remain valid until expiry under Article 34
• □ Completed the gap comparison against the Article 12 renewal checklist
• □ Agreements designate the party bearing testing costs under Article 29
• □ No trial import arrangements exist for unregistered products

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.