The Regístrelo Portal and Digital Signature Requirements

1. Key takeaways

Articles 10.1 and 10.2 of the main regulation establish two hard rules: all three categories of application, namely registration, renewal and post-registration changes, must be handled through the Regístrelo portal platform, and all digitally signed documents must comply with the integrity, authenticity and temporal validity safeguards issued by the Central Bank (Banco Central). The first rule positions Regístrelo as the statutory and exclusive filing channel; the second elevates signature technical requirements to the level of regulation. The platform rules themselves are set out in Decreto Ejecutivo N° 37988-S of 2013-10-03, published in La Gaceta N° 203. Read together, the two rules mean that both the channel of filing and the form of signature are regulated matters: a dossier that satisfies the substantive content requirements can still fail at the formal layer if it arrives through the wrong channel or carries a signature that does not meet the prescribed safeguards.

2. Legal basis

The table below consolidates the provisions governing the filing channel, digital signatures and the platform decree, together with the one reviewing period that can be read directly from an official text.

3. Expert insights

Insight 1: Article 10.1 phrases the platform obligation as deben ser tramitados a través de, an obligatory rather than permissive formulation. This means Regístrelo is not a recommended channel or a convenience channel but the statutory and only route. The practical consequence is direct: a dossier submitted as an email attachment, by paper delivery, or at a service counter does not constitute a valid application and does not start any review period.

Insight 2: Article 10.2 anchors the signature standards to the Central Bank rather than to standards owned by the Ministry of Health. This design moves the question of signature validity out of the health regulatory field and into the field of national financial infrastructure: digital signature certificates must satisfy the integrity, authenticity and temporal validity safeguards published by the Central Bank. The practical implication is that companies cannot simply choose any electronic signature service; they must confirm that the certificate meets the Central Bank standards, in particular the safeguard of temporal validity, meaning that the signature remains verifiable as valid at the time of signing even after the certificate expires or is revoked.

Insight 3: Within the same regulation, a digital signature and a digitally signed notarised certification are two different things, and the two are frequently confused. Articles 10.2 and 10.3 deal with documents signed by the applicant itself, namely the application forms, and require the digital signature to comply with the Central Bank standards. Article 10.17 deals with foreign public documents, which, in addition to legalisation or apostille, must be accompanied by a certificación notarial firmada digitalmente, a notarised certification signed digitally, or handled under DE 37988-S. The former is a signature technology question; the latter is an additional layer of proof of authenticity for foreign documents. Treating them as interchangeable is one of the most common filing errors observed in practice, and the correction almost always costs an extra round of document procurement abroad.

Insight 4: Article 5 of the approving decree, which amends DE 37988-S, is the only specific review period in this volume that can be read directly from an official text. The provision rewrites Article 34.2.4.1 of DE 37988-S to say that, for notification-type (notificación) post-registration change applications for EMB, the Ministry of Health has at most 5 working days from receipt of the application to approve and issue the registration or to reject it. By comparison, the review periods for registration and renewal are referred by Article 14 of the main regulation to DE 37988-S, and no number of days is given inside the main regulation itself, as discussed in article 37 of this series.

4. Practical recommendations

• Obtain a digital signature certificate that complies with the Central Bank standards before filing, and verify its temporal validity function; do not substitute an ordinary electronic seal.
• File registration, renewal and change applications exclusively through the Regístrelo portal, never by email or paper, and retain filing receipts and timestamps.
• After completing legalisation or apostille for foreign public documents under Article 10.17, separately obtain the digitally signed notarised certification; the two layers cannot replace each other.
• Have application forms signed by the licence holder, the legal representative or an authorised person under Article 10.3; where an authorised person signs, the power of attorney must state this authority expressly.
• Schedule notification-type changes through the 5 working day track under Article 5 of the approving decree and all other changes through the regular track, without mixing the two.

5. Verification checklist

• □ Regístrelo confirmed as the statutory and exclusive filing channel (Article 10.1)
• □ Digital signature certificate complies with the Central Bank integrity, authenticity and temporal validity standards (Article 10.2)
• □ Application forms digitally signed by a qualified signatory (Article 10.3)
• □ Foreign public documents legalised or apostilled plus digitally signed notarised certification (Article 10.17)
• □ Notification-type changes scheduled on the 5 working day track (Article 5 of the approving decree)
• □ Filing receipts and timestamps retained

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