EMB Definition and the Treatment of Software and Medical Apps

1. Key takeaways

Costa Rica does not use the term “medical device” (dispositivo médico); the statutory concept is biomedical equipment and materials (Equipo y Material Biomédico, EMB). Article 2.1 of the main regulation expressly extends its scope to EMB accessories, software and medical mobile applications (apps), and definition 4.2 further defines a mobile application as two kinds: an application that itself meets the criteria for classification as EMB, and an application used as an accessory to an already regulated EMB or that converts a mobile platform into a regulated EMB. Standalone software (SaMD) and mobile apps therefore fall within EMB jurisdiction in Costa Rica; they are not outside the law.

• EMB, not dispositivo médico, is the statutory term in Costa Rica.
• Article 2.1 covers EMB accessories, software and medical mobile apps.
• Definition 4.1 requires an accessory to be specifically designed by the manufacturer and not to achieve the intended function on its own.
• Software is classified under the active-device rules of Annex A (rules 8–11), by function rather than by carrier form.
• Software validation study is a listed dossier item for Clase 3 (Article 12.2.4), not an optional extra.

2. Legal basis

The provisions below set out how EMB, accessories, software and mobile applications are brought into scope, defined and classified under RTCR 505:2022.

3. Expert insights

Insight one: the main regulation uses EMB rather than dispositivo médico, and the terminology difference directly affects searching and filing. Chinese-language materials often render Costa Rica’s EMB simply as medical device, but when preparing Spanish-language documents, searching Ministry of Health forms, or checking Regístrelo portal fields, the statutory term EMB must be used. Article 1 of the main regulation opens with “en adelante denominados EMB” and uses only the abbreviation thereafter. In multi-country registration programmes run in parallel, companies should take particular care not to mix Costa Rican terminology with that of neighbouring countries that use dispositivo médico.

Insight two: the definition of accesorio contains three qualifying conditions, all of which must be met. Definition 4.1 requires that an accessory be specifically designed by the manufacturer, used together with an EMB, and intended to support, supplement or enhance that EMB’s performance, while not achieving the intended function on its own. The third condition is the key exclusion: if an item can achieve a medical function independently, it is not an accessory but an EMB in its own right and requires its own registration. Article 7.6 of the main regulation (covered in detail in article 21 of this volume) builds on this by allowing accessories to be registered separately.

Insight three: software classification does not follow a standalone rule; it is determined by the host function or by the active-device rules. The main regulation does not create a dedicated software rule in Annex A; instead it writes software explicitly into four rules for active devices: rule 8 (ionizing radiation, including software that controls or monitors such equipment, Clase 3), rule 9 (active therapeutic devices, Clase 2 upwards), rule 10 (active diagnostic devices, Clase 2 upwards), and rule 11 (devices for infusion or removal of substances, Clase 2 upwards). The implication is that the class of software is determined by the function it controls or performs, not by its carrier form. Software for mammography (rule 8 b)) falls in Clase 3, while general radiography software from the same manufacturer falls in Clase 2.

Insight four: the software validation study is an expressly listed dossier item for Clase 3, not an option. Article 12.2.4 writes “estudio de validación del software, si aplica” into the clinical evidence list for Clase 3. For products whose core is an algorithm, this item often determines whether the review can be passed; the Clase 2 dossier list (Article 11) does not list it separately. When planning timelines, companies should prepare software validation materials to the Clase 3 standard so as to avoid being asked for supplements mid-review.

4. Practical recommendations

• At the product-characterization stage, first determine whether the item is a standalone EMB or an accessory: items that achieve a medical function independently proceed as standalone EMB through registration; items that only support another device are handled as accessories, with the host device identified in the technical specifications.
• Classify software and apps by function, applying Annex A rules 8–11, and note the different baseline classes of the four rules for radiation, therapy, diagnosis and infusion.
• For Clase 3 and above, prepare the software validation study early (Article 12.2.4) and state the version and the algorithm’s purpose in the technical specifications.
• Draft the technical specifications item by item under Article 11.4.1 a) to l); the “detailed description and identification code” of software must include the version number and deployment form.
• Use the EMB term uniformly in all Spanish-language documents; do not carry over the dispositivo médico wording used in neighbouring countries.

5. Verification checklist

• □ Confirm the product is an EMB (including accessories, software and medical apps) and not an excluded item
• □ Determine whether the item is a standalone EMB or an accessory (definitions 4.1 and 4.2)
• □ Classify software by function under Annex A rules 8–11
• □ Clase 3 projects have the software validation study prepared (Article 12.2.4)
• □ Technical specifications include version, identification code and deployment form (Article 11.4.1 a))
• □ Spanish-language documents use the EMB term uniformly

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