Paraguay Medical Device Post-Market Compliance: DINAVISA Inspections, Sampling and Cost Allocation (Article 29)

1. Key takeaways

1. Article 29: DINAVISA may at any time order a review, inspection, sampling and analysis (revisión, inspección, toma de muestra y análisis de oficio) of any device, in order to verify its functionality, effectiveness, quality and safety.
2. Cost allocation rules:
   • Registered products: the costs of tests, studies, analyses or inspections are borne by the registration holder (titular del producto);
   • Products without a registration or NSO: the costs are borne by the importer or the manufacturer.
3. The inspection power extends to premises: under Article 9 of Law 4659/12, DINAVISA may conduct verifications at health institutions and enterprises engaged in the sale of devices.
4. Article 30: violations of the Resolution are addressed through the necessary preventive and corrective measures under the violation and sanction regime in force at DINAVISA.

Sampling also serves a market-intelligence function for the authority: laboratory results feed the risk analysis that decides where the next inspections go, which means a single unfavorable result can raise the inspection probability for an entire product line, not only for the batch that was sampled.

2. Legal basis

Two instruments cooperate here. Resolution 226/2024 supplies the product-level powers of review, inspection, sampling and analysis, together with the cost allocation and the link to the sanction regime through Article 30. Law 4659/12, the older health safety statute, supplies the premise-level power that reaches hospitals and commercial establishments through Article 9. The combination means that a device can be examined on the bench, at the warehouse and at the point of use, and that the party paying for the examination depends on the legal status of the product rather than on who requested the test.

The allocation of costs in Article 29 follows the legal status of the product at the moment of the intervention, not the identity of the party that holds it in the channel. A registered device tested in a hospital is charged to its registration holder; the same model without a registration, intercepted during import or found in the distribution chain, is charged to the importer or the manufacturer. The rule also removes any incentive to argue about responsibility after the fact: the statute fixes the paying party in advance, so disputes inside the supply chain can only redistribute an already-defined cost, never eliminate it. This makes the registration status of every unit in the channel a financial question, and it is one more reason to keep imports strictly aligned with certificates.

3. Expert insights

Insight one: at any time, de oficio and at the holder’s cost together change the cost expectation of holding a certificate. The three operative expressions in Article 29 are en cualquier momento, meaning at any time, de oficio, meaning ex officio, and a costas del titular, meaning at the cost of the holder. Read together they mean that a certificate-holding company may face an unexpected testing bill with no warning, and cannot refuse on the ground that it never requested the test. Budgeting for regulatory sampling is therefore not an optional contingency but a structural cost of holding a Paraguay registration, and finance teams should treat it as a recurring line item rather than a surprise.

Insight two: placing the cost of unregistered products on the importer or manufacturer is a direct price on shipping before certification. The contrast between the two limbs of Article 29 shows deliberate legislative design: the cost burden for products lacking a registration or NSO is pushed onto the importer or the manufacturer, creating an economic deterrent at exactly the point where the decision to ship uncertified goods is taken. For companies importing on behalf of third parties, this makes contractual clarity about who bears regulatory testing costs a commercial necessity, not a legal nicety.

Insight three: the extension of inspection powers to the point of use means hospitals are inside the regulatory perimeter. Article 9 of Law 4659/12 authorizes verifications at health institutions. For implantable devices this connects directly with the implant card requirement of Annex V: from the implantation event to the point of clinical use, the device remains within verifiable range. Manufacturers of implants should therefore treat hospital-side documentation, including the correct completion and retention of the implant card, as part of their own compliance perimeter rather than as a customer formality.

4. Practical recommendations

1. Create a dedicated budget line for regulatory sampling response within the holding cost of each certificate, sized to cover the potential cost of laboratory analysis without emergency approvals.
2. Clarify with local partners who bears the costs under Article 29, and write the allocation into the cost clauses of the distribution or service agreements, including the case of unregistered goods discovered in the channel.
3. Maintain consistency between the physical product and the registered documentation, because product-to-dossier mismatch is the fastest route to an unfavorable sampling outcome.
4. For implantable devices, verify that the implant card of Annex V is correctly completed and retained on the hospital side, and provide clear completion instructions to clinical customers.

The premise-level power under Law 4659/12 also changes the audience for compliance communication. Because verifications can occur at health institutions and commercial establishments, field staff and clinical customers are part of the inspection surface. Briefing them on what documentation must accompany a device, and on how to respond to a DINAVISA visit, closes the gap between the quality system in the factory and the reality of the point of use. A short, written inspection-response protocol shared with local partners is usually sufficient.

5. Verification checklist

• □ The budget contains a dedicated line for regulatory sampling response
• □ The party bearing the costs under Article 29 is written into agreements
• □ Consistency between product and registered documentation is checked periodically
• □ A completed implant card workflow is in place for implantable devices
• □ It is confirmed that the inspection power extends to health institutions (Article 9 of Law 4659/12)

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 inspection preparedness, cost allocation or any other regulatory matter, contact info@grzanglobal.com.