Concordance with Canadian SOR/98-282 Medical Devices Regulations

1. Key takeaways

Article 23 of the main regulation (CONCORDANCIA) is a single sentence: “Concuerda parcialmente con SOR/98-282, Canadian Medical Devices Regulations.” — this main regulation is partially consistent with the Canadian Medical Devices Regulations (SOR/98-282). This is the only statement in the Costa Rican regulation, within the Central American market, that expressly declares an international concordance in the body of the regulation itself, and its benchmark is the Canadian rules — not the EU MDR and not the US FDA system. For companies that have already completed classification in Canada, this provision provides a textual basis for transferring classification determinations under a similar rule set.

• Article 23 declares partial concordance with SOR/98-282, the Canadian Medical Devices Regulations.
• Partially (parcialmente) is a limiting word; it does not mean equivalence.
• Annex A.1’s four-group structure corresponds closely to the Canadian classification rule groups.
• The concordance covers the classification rule system only, not registration, labelling or change procedures.
• Acceleration should proceed through the equivalence-recognition channel of Article 17, not through the concordance statement.

2. Legal basis

The provisions below reproduce the concordance statement and the articles and statutes that frame it, including the domestic legal basis for adopting technical regulations aligned with international rules.

3. Expert insights

Insight one: partially (parcialmente) is a limiting qualifier and must not be read as equivalence. Article 23 uses parcialmente, not totalmente. The meaning is that the main regulation took the methods and structure of the Canadian classification rules as a reference, but it is not a wholesale transplant. In practice, Canadian classification outcomes can serve as a starting point for the determination and as supporting argument, but not as a direct basis for skipping the determination; the Annex A rules must still be applied provision by provision, with attention to the administrative-resolution channel of Article 8.3.

Insight two: the Canadian benchmark left identifiable traces in the structural design. The four-group division of Annex A.1 (invasive A.1.1, non-invasive A.1.2, active A.1.3, special rules A.1.4) corresponds closely to the grouping of the classification rules in Schedule 1 of the Canadian Medical Devices Regulations, and the wording of determination elements in the rule texts, such as continuous use for 30 days or more, invasion through body cavities, and active therapy or diagnosis, is likewise similar. For registration professionals familiar with the Canadian rules, this structure markedly reduces the learning cost, and it is the reason this volume writes classification determinations as rule number plus determination elements.

Insight three: this provision makes country-level benchmarking a searchable differentiator for Costa Rica. Most technical regulations of other Central American countries do not name a benchmark in the body of the regulation, or follow the Central American regional harmonization (RTCA) system. Costa Rica’s express reference to the Canadian rules is consistent with its path of adopting technical regulations under Ley 8274, the National Quality System, in accordance with WTO/TBT obligations (the opening recital of the approving decree cites both Articles 19–34 of Ley 8274 and Ley 7475). In multi-country parallel registration programmes, companies can treat an existing Canadian classification as an acceleration factor in the Costa Rica project schedule.

Insight four: the concordance statement does not cover the other systems of the main regulation. Article 23 sits at the end of the regulation, immediately before the prohibitions of Article 24 and the references of Article 25, and its reach is limited to the classification rule system. The registration procedures (Articles 10, 11, 12 and 13), labelling (Article 19), post-registration changes (Article 18) and equivalence recognition (Article 17 and Annex B) are Costa Rica’s own designs, for which no correspondence with the Canadian rules exists. Using Canadian experience to infer how those elements work has no textual basis.

4. Practical recommendations

• For products already classified in Canada, translate and organize the Canadian classification rationale as reference material for the Costa Rican determination, but still re-verify rule by rule under Annex A and issue a local determination document.
• Write classification determinations uniformly in the three-part form of rule number, determination elements and conclusion, so they can be compared against the Canadian rules and can answer an Article 22.2 review.
• Do not treat a Canadian registration certificate as a waiver of determination or an acceleration credential for Costa Rica; acceleration should go through the equivalence-recognition channel of Article 17 (see articles 18 and 20 of this volume).
• For new products not covered by the rules, still apply for an administrative resolution under Article 8.3; do not substitute the class of a similar Canadian product.
• In multi-country parallel programmes, archive the Canadian classification materials as a shared asset for reuse in Costa Rica and later markets.

5. Verification checklist

• □ Original text of the Article 23 concordance statement and the limiting word partially recorded
• □ Annex A rules re-verified provision by provision; foreign conclusions not carried over directly
• □ Classification determination written in the three-part form of rule number, determination elements and conclusion
• □ Rule-uncovered items submitted for an administrative resolution under Article 8.3
• □ Acceleration needs assessed through the Article 17 equivalence-recognition channel, not through the concordance statement
• □ Canadian classification materials archived for multi-country reuse

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Costa Rican market. Our team manages Ministry of Health (Ministerio de Salud) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com