Class 1 Devices: Exempt from Sanitary Registration, Not from Obligations

1. Key takeaways

Article 2.4 of the main regulation is a single sentence, yet structurally complete: “Los EMB clase I no requieren registro sanitario para su comercialización y uso, pero sí les aplican los requisitos de importación, etiquetado, publicidad, vigilancia y control.” — EMB of Clase 1 do not require a sanitary registration for commercialization and use, but the five requirements of import, labelling, advertising, vigilance and control still apply. This is the point in the Costa Rican system most often written wrongly in Chinese-language materials. There are two wrong directions: one claims that all devices must be registered, and the other claims that exemption from registration means exemption from regulation. Neither matches the original text.

• Clase 1 EMB are exempt from sanitary registration for commercialization and use (Article 2.4).
• Five requirements remain applicable: import, labelling, advertising, vigilance and control.
• Article 19.1.17 (registration number on the label) does not apply to products exempt from registration.
• Article 22.2 lets the Ministry of Health require materials to determine the true classification of a product treated as Clase 1.
• Failure to register where required is a serious infringement (Article 2, II.b), of the approving decree).

2. Legal basis

The provisions below establish the Clase 1 exemption, the retained obligations that accompany it, and the powers by which the exemption can be revisited.

3. Expert insights

Insight one: Article 2.4 is a compound sentence of exemption plus retention, and the retention list has five items, not two. The common compressed rendering in Chinese-language materials is “exempt from registration but must meet labelling requirements”, which omits import, advertising, vigilance and control. Each of the four omitted items has corresponding provisions and accompanying decrees: import corresponds to Article 2.1.2 and the operating permit (Article 10.4); advertising corresponds to Article 20; vigilance corresponds to Article 21 and DE 39342-S; control corresponds to Article 22. Omitting items leads directly to companies conducting only labelling compliance for Clase 1 products while leaving vigilance and advertising unaddressed.

Insight two: Article 19.1.17 confirms the scope of the exemption from the reverse side. Among the 18 mandatory label contents, item 19.1.17 requires the EMB registration number, but the provision carries its own proviso: “este requisito no aplica para productos exonerados de registro conforme a las disposiciones del presente reglamento” — the requirement does not apply to products exempt from registration under the regulation. This is a self-consistent design: Clase 1 products have no registration number and are therefore excused from that label item, while the remaining 17 labelling requirements still apply.

Insight three: Article 22.2 is the price attached to the Clase 1 exemption. The provision authorizes the Ministry of Health, where it has reasonable grounds to consider that a product imported or sold as Clase 1 does not belong to that risk class under Annex A, to require the registration holder or its in-country legal representative to submit materials to determine the true classification of the product. The implication is that a company’s own Clase 1 determination is not final; the Ministry of Health retains review power. Once reclassified as Clase 2 or above, the earlier sale without registration falls within the serious infringement of Article 2, II.b), of the approving decree (failure to perform the registration obligation).

Insight four: Clase 1 status is determined by the Annex A rules, not by a product list. The main regulation contains only Annex A (classification rules) and Annex B (equivalence-recognition procedure); there is no annex of the kind sometimes claimed, a list of Clase 1 products. Determination therefore proceeds rule by rule: rule 7 for general EMB (residual rule for other non-invasive devices, Clase 1), rule 12 (residual rule for other active devices, Clase 1), rule 3 b) (reusable surgical instruments, Clase 1), rule 2 a) (invasive devices in body cavities from mouth/nose to pharynx or from ear canal to eardrum, Clase 1), rule 3 e) (non-surgical invasive devices in continuous use for at most 60 minutes, Clase 1), rule 4 a) (devices contacting breached skin acting only as mechanical barriers, for compression or for absorbing exudates, Clase 1), and rule 14 c) (devices containing animal-source or recombinant DNA components that only contact intact skin, Clase 1); for IVDs, rule 8 (culture media residual rule, Clase 1) and rule 9 (final residual rule, Clase 1). The industry-circulated claim of an “annex listing 62 Clase 1 products exempt from regulation” does not exist in the main regulation and is not accepted in this volume.

4. Practical recommendations

• Clase 1 products still require labelling compliance (17 of the 18 items in Article 19, excluding 19.1.17), advertising compliance (Article 20) and connection to the technical vigilance system (Article 21).
• Build a written classification self-evidence file stating the Annex A rule numbers applied, the product characteristics and the reasons for the conclusion, ready for submission under an Article 22.2 review.
• For imports, confirm that the importer holds a valid sanitary operating permit (Article 10.4); exemption from registration does not waive the operator qualification requirement.
• For products with unclear classification boundaries (especially software, animal-source components, and devices contacting breached skin), perform a pre-market classification assessment to reduce the probability of reclassification.
• Unify the internal wording of exemption from registration as exempt from sanitary registration, obligations not waived, so that sales and customer-facing teams do not drift off message.

5. Verification checklist

• □ Clase 1 determination completed under the Annex A rules with written reasons retained
• □ Labelling compliant on 17 items (item 19.1.17 not applicable by exemption)
• □ Advertising reviewed under Article 20
• □ Technical vigilance connected to the DE 39342-S system
• □ Importer holds a valid sanitary operating permit (Article 10.4)
• □ Materials plan prepared for an Article 22.2 classification review

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