Paraguay Device Families, Systems and Kits: Grouping Rules under Articles 20 and 21

1. Key takeaways

1. Article 21 allows registration applications to be submitted for families (familias), systems (sistemas) and Kits of devices, with the grouping to be made according to the definitions in the resolution. Grouping is therefore a defined regulatory construct, not a commercial convenience that can be arranged freely.
2. The key rule: the procedure is determined by the product with the highest risk class within the family, system or Kit. One high-class component pulls the entire grouping into the corresponding procedure, together with its review depth and timeframe.
3. Article 20 provides that combination devices (dispositivos médicos combinados) are evaluated according to the scientific and technical approach of the regulatory authority of the reference country, although the applicant may still be asked to supplement new technical and administrative requirements.
4. Item 20 of the definitions chapter of the resolution defines kits/sets as collections of devices that could be registered individually but are combined into a single sales unit for a specific use or specific operation.

2. Legal basis

The substantive rules on grouping sit in the resolution, while the operational instructions, at page 4, govern how the grouping is expressed on the platform: the commercial name, the model and the accessory details are declared in structured fields, and accessories carry their own reference code, identifying name and specifications. Because the platform fields are what reviewers and inspectors see first, the grouping declared there must match the definitions used in the resolution; a family declared as a kit, or accessories omitted from the accessory details, creates a mismatch that surfaces later as a finding.

The grouping decision also reaches forward into the post-market phase. Every certificate issued for a family, system or kit carries the grouping inside its scope, so a change to any component under the Article 13 classification is evaluated against the whole grouping, not against the component alone. Removing a component, adding a model or altering a shared accessory can shift the highest class, and if the change moves the grouping into a higher class, the existing certificate no longer describes the product as sold. For that reason, the component list, the class of each component and the grouping rationale should be kept as living documents in the regulatory file, updated whenever the portfolio changes, so that the original grouping logic remains verifiable years after the certificate was issued.

3. Expert insights

Insight one: filing by family is an efficiency tool, but the price is the highest class governs. Article 21 allows consolidated applications for families, which significantly reduces the number of certificates and the workload of subsequent changes; but if a single Class III component enters the grouping, the whole family proceeds through the Class III procedure. Whether to group is in substance a trade-off between the number of certificates and their maintenance cost on one side, and the depth and duration of a single review on the other. The right answer differs by portfolio: consumable-heavy portfolios group aggressively, while portfolios with one high-class item often isolate that item in its own application.

Insight two: the treatment of combination devices shows that Paraguay recognizes cross-boundary products. Article 20 does not set its own rules for determining combination status; it refers to the scientific and technical approach of the reference authority, such as whether the drug or the device provides the principal intended action. This means that the classification and the principal mode of action determination for a combination device depend heavily on the existing regulatory conclusion of the country of origin, and manufacturers from China and other origins should prepare documentation from the original approval authority expressing its position on the principal mode of action. DINAVISA may still request supplementary technical and administrative requirements, so the foreign conclusion frames the review but does not close it.

Insight three: declaring accessories and filing by family are two different matters. The operational instructions require the accessories of a device to be declared individually, including reference code, identifying name and specifications, and to be indicated in the CLV or technical documentation. Accessories may be declared together with the main device, but the grouping rules for kits/sets differ: the former is a main device plus accessories, while the latter is a sales unit composed of multiple devices that could each be registered independently. Confusing the two constructs leads to the wrong declaration structure on the platform and, downstream, to the wrong change classification.

4. Practical recommendations

1. Before deciding on a family application, list every component in the family with its class, and confirm whether the procedure and timeframe corresponding to the highest class are acceptable; the exercise takes little time and prevents the most expensive grouping mistakes.
2. For combination device projects, prepare in advance the written conclusion of the original approval authority on the principal mode of action (PMOA), translated and ready to be submitted as part of the technical documentation.
3. Keep the accessory list in one-to-one correspondence with the CLV and technical documentation, and mark on the relevant document pages, by highlighting or explicit reference, the corresponding accessories and models so the reviewer can trace each accessory without interpretation.
4. Handle subsequent changes to a family under the classification of Article 13; changes affecting the composition or function of the family generally fall into Class II changes, which require approval before implementation.

5. Verification checklist

• □ All components of the family listed together with their classes before the grouping decision
• □ Procedure confirmed to follow the highest class in the grouping
• □ Principal mode of action conclusion document obtained from the original approval authority for combination devices
• □ Accessory list mapped one-to-one to the CLV and technical documentation with markings applied
• □ Changes within the family pre-classified under Article 13 before implementation

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support for manufacturers, importers and authorized representatives in Paraguay, covering grouping strategy, combination device documentation and change classification under Articles 20 and 21 of Resolución DINAVISA N° 226/2024. Contact: info@grzanglobal.com