Who Regulates Medical Devices in Costa Rica

1. Key takeaways

The competent authority for the regulation, registration, verification and control of biomedical equipment and materials (Equipo y Material Biomédico, EMB) in Costa Rica is the Ministry of Health (Ministerio de Salud), and its operating body is the Directorate for the Regulation of Products of Health Interest (Dirección de Regulación de Productos de Interés Sanitario, DRPIS). All applications for registration, renewal and post-registration changes must be filed electronically through the Regístrelo portal; offline submission is not permitted. Throughout RTCR 505:2022 the rights and obligations are assigned to the figure of the Ministerio de Salud, and this point directly determines that the counterparty for company appeals, objections and remedies is the Ministry of Health itself, not any individual directorate.

• Ministerio de Salud is the sole legal counterparty for registration, verification, infringement findings and sanctions.
• DRPIS is the operating directorate, identified through Costa Rica’s official WTO notification, not named in the main regulation.
• Regístrelo is the statutory sole channel for registration, renewal and post-registration change applications.
• Digital signatures must satisfy the Central Bank’s integrity, authenticity and temporal-validity guarantees.
• National verification is carried out by the Ministry of Health or by inspectors it authorizes.
• Authorizations for ionizing radiation sources are issued by the radiological protection directorate under Article 11.6.

2. Legal basis

The provisions below establish the institutional and procedural basis for the regulation of EMB in Costa Rica, from the approval of the main regulation to the operation of the Regístrelo portal and the powers of verification.

Additional institutional note: the identity of DRPIS as the responsible authority is recorded in Costa Rica’s official notification to the WTO under the Agreement on Technical Barriers to Trade (Ministerio de Salud, Dirección de Regulación de Productos de Interés Sanitario, telephone (+506) 2233-6922). The name of this directorate does not appear in the body of the main regulation itself, which consistently refers only to the Ministerio de Salud.

3. Expert insights

Insight one: the main regulation recognizes only one legal subject, the Ministry of Health, and DRPIS is an internal division of labour. Articles 1, 9, 14 and 22.1 of the main regulation, together with Articles 2 and 3 of the approving decree, vest the powers to approve registrations, to verify, to determine infringements and to impose sanctions entirely in the Ministerio de Salud. This means that the issuing body of a sanitary registration is the Ministry of Health, and the body that orders market withdrawal or cancellation is likewise the Ministry of Health. When a company designs its dispute-response pathway, the legal counterparty is the Ministry of Health; narrowing the communication channel to a particular technical office creates errors of subject matter in procedural documents. The functional position of DRPIS can be confirmed through the WTO notification, but it should not be presented as replacing the Ministry of Health in legal documents.

Insight two: Regístrelo is the legally mandated sole channel, not a recommended channel. The original wording of Article 10.1 reads “deben ser tramitados a través de la plataforma del portal “Regístrelo””, which is mandatory language. The same article anchors the procedure in DE 37988-S, meaning the portal’s operating rules carry the force of regulation. Article 10.2 further requires that all digital signatures satisfy the Central Bank’s triple guarantees of integrity, authenticity and temporal validity. The combined practical effect of these two provisions is that paper dossiers, scanned documents sent by e-mail, or electronic files generated through a company’s internal seal workflows do not constitute valid submissions.

Insight three: the verification subject is the Ministry of Health or its authorized inspectors, and the scope of authorization is written into the main regulation. Article 22.1 allows the Ministry of Health to authorize inspectores to perform verification. This is an authorization clause that is often overlooked: the personnel who arrive on site may not be career staff of the Ministry of Health, yet the legal consequences of their inspection acts are attributed to the Ministry of Health. When receiving an inspection, companies should verify the inspector’s authorization credentials and request a written record of the scope of the inspection, rather than relying solely on an identification badge.

Insight four: the authorization for ionizing radiation sources is the only prior licence in the main regulation that names a specific directorate, and that directorate is written in two different ways within the regulation. Article 11.6 assigns the authorization to the “Dirección de Protección Radiológica y Salud Ambiental” (Directorate of Radiological Protection and Environmental Health), while Articles 18.10.5 and 18.16.7 refer to the same function as “Dirección de Protección al Ambiente Humano”. The coexistence of two institutional names in the same regulation is a consistency issue in the text of the main regulation. The practical approach is to use the name in Article 11.6 in external correspondence, and to state in the submission materials the function indicated by both names, so that a formal review is not rejected over a name discrepancy.

4. Practical recommendations

• At project start-up, register the Ministry of Health (Ministerio de Salud) uniformly as the recipient of official correspondence, deficiency notices and decision documents, and map it internally to DRPIS’s business window in your own workflow.
• Before opening a Regístrelo portal account in Costa Rica, first obtain the digital signature certificate and confirm that the certificate meets the Central Bank’s temporal-validity guarantee requirements; do not substitute a scanned signature for a digital signature.
• For products containing ionizing radiation sources (including software used to control or monitor such equipment), schedule the radiation source authorization as a parallel matter independent of the sanitary registration well in advance (Article 11.6, DE 24037-S).
• Establish an inspection-response plan: verify the inspector’s authorization document, retain a copy of the inspection record, and relay the record to the in-country legal representative within 24 hours.
• Before each submission, check the current versions of the main regulation and of DE 37988-S, as well as the form version numbers published by the Ministry of Health on the Regístrelo portal, and never reuse an outdated form.

5. Verification checklist

• □ Confirm that the competent authority is the Ministerio de Salud and the operating body is DRPIS
• □ Confirm that registration, renewal and change applications are all filed through the Regístrelo portal (Article 10.1)
• □ Confirm that digital signatures meet the Central Bank integrity, authenticity and temporal-validity standards (Article 10.2)
• □ Confirm that the verification subject is the Ministry of Health or its authorized inspectors (Article 22.1)
• □ Confirm whether the product contains ionizing radiation sources and whether a parallel source authorization is required (Article 11.6)
• □ Record the difference in directorate names between Articles 11.6 and 18.10.5 for formal-review inquiries
• □ Check the current form version numbers on the Regístrelo portal

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