Tecnovigilance Obligations and Decree 39342-S

1. Key takeaways

Article 21 of the principal regulation says only one thing: any person responsible for an EMB (toda persona responsable de un EMB) must comply with Decreto N° 39342-S of 23 October 2015, the Regulation of the National Technovigilance System, published in Alcance N° 116 to La Gaceta N° 246 of 18 December 2015. In other words, technovigilance obligations in Costa Rica are not developed inside the principal regulation; instead, the regulation points wholesale to an independent decree. At the same time, the fourth paragraph of Article 3 of the approving decree provides that when the Ministry of Health becomes aware of an adverse event or a public health risk, it may require withdrawal from the market as a preventive protective measure — so vigilance reporting and product disposal are linked by design.

• Technovigilance in Costa Rica rests on a standalone decree, DE 39342-S, which the principal regulation incorporates by reference in Article 21.
• The duty holder under Article 21 is any person responsible for an EMB, a formulation broader than the registration holder alone.
• Clase 1 products are exempt from registration under Article 2.4, but their vigilance obligation remains fully applicable.
• Under the approving decree, mere awareness of an adverse event can trigger a request for market withdrawal as a preventive measure, so reporting must be paired with a risk assessment and a response plan.
• This volume has not obtained the original text of DE 39342-S and therefore does not list specific reporting deadlines.

2. Legal basis

The obligations described above rest on two instruments that must be read together: the technical regulation RTCR 505:2022, which assigns and anchors the vigilance duty, and the approving decree Decreto Ejecutivo N° 43902-S, which supplies the enforcement and withdrawal mechanism. The table below lists each provision relied on in this volume.

3. Expert insights

Insight one: Article 21 uses the wording person responsible (persona responsable) rather than registration holder, so the scope of duty holders is wider. The principal regulation states in Article 6.1 that the holder of the product is the responsible person for the EMB (El titular del producto será el responsable del EMB); yet Article 21 switches to the expression toda persona responsable de un EMB. Read together with Article 10.11, which allows import and distribution to be delegated to third parties, and Article 10.3, which requires a legal representative in the country, the meaning is that the registration holder, the domestic legal representative and the authorised distributor may each become subject to vigilance duties within their own segment of the chain. When a company allocates vigilance responsibilities, it should therefore design them by role rather than by a single entity.

Insight two: The vigilance obligation applies equally to Clase 1 products, which is the concrete proof inside Article 21 that exemption from registration is not exemption from duties. Article 2.4 expressly preserves the vigilancia requirement, and Article 21 then points it to DE 39342-S. The meaning is that even where a product does not need registration, the person responsible for it must still comply with the National Technovigilance System Regulation. This pairing is a specific illustration of the loose front end and tight back end structure of the Costa Rican system — what Clase 1 exempts is registration, not vigilance.

Insight three: The fourth paragraph of Article 3 of the approving decree ties vigilance directly to market withdrawal, creating a mechanism in which reporting itself carries risk. That paragraph provides that when the Ministry of Health becomes aware (conocimiento) of any adverse event, harm event or situation endangering public health, it may require withdrawal from the market as a preventive and protective measure. Note the wording is awareness rather than a finding of infringement — no completed infringement determination is needed first. This means the information a company reports can itself become the trigger for withdrawal. This is not a reason to discourage reporting, because failure to report falls under Article 2 II.b) of the approving decree as a breach of duty; rather, it requires the company to prepare a risk assessment and a disposal plan at the same time as it reports.

Insight four: This volume has not obtained the original text of DE 39342-S and therefore does not list specific reporting time limits. The decree was published in Alcance N° 116 to La Gaceta N° 246 of 18 December 2015. The principal regulation only points to it and does not restate its reporting categories or deadlines. Industry-circulated figures about specific reporting hours are not supported by any official text seen, and this volume does not adopt them; companies building a vigilance system should obtain the current original text of DE 39342-S directly and configure their processes according to it. Any internal figure at this stage should be treated as a practical estimate, pending verification against the decree itself.

4. Practical recommendations

• Obtain the current original text of DE 39342-S and build the vigilance process according to its requirements, not according to industry-circulated deadlines.
• Allocate vigilance duties by role: the registration holder bears overall responsibility, the domestic legal representative handles receipt of and response to communications, and authorised distributors collect information at the channel level.
• Bring Clase 1 products into the vigilance system as well; they are not exempted by their registration exemption (Articles 2.4 and 21).
• Establish a pre-reporting risk assessment mechanism: prepare a market withdrawal response plan at the same time as reporting (fourth paragraph of Article 3 of the approving decree).
• Link vigilance records to the registration ledger so they can be retrieved on demand during renewal (Article 16) and verification (Article 22).

5. Verification checklist

• □ The current original text of DE 39342-S has been obtained and the process configured according to it
• □ Vigilance duties have been allocated by role (registration holder, legal representative, distributor)
• □ Clase 1 products have been brought into the vigilance system (Articles 2.4 and 21)
• □ The reporting process carries an attached risk assessment and market withdrawal plan
• □ Vigilance records have been linked to the registration ledger
• □ Industry-circulated reporting deadlines have not been adopted

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