Review timelines and five working day notifications

Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20

1. Key takeaways

Article 14 of the technical regulation makes only one directional provision on review timelines: the Ministry of Health reviews the submitted documentation with the aim of approving or rejecting the registration, and does so within the time limits contained in Decreto Ejecutivo N° 37988-S (the Regístrelo portal decree). The regulation itself states no number of days. The only specific time limit that can be read from the official texts in this volume comes from Article 5 of the approving decree, which rewrites Article 34.2.4.1 of DE 37988-S as follows: for notification-type (notificación) post-registration change applications for EMB, the Ministry has at most 5 working days from receipt to approve and issue the registration or to reject it. Everything else — registration and renewal durations in particular — must be verified against the current text of DE 37988-S rather than read from the technical regulation.

2. Legal basis

The provisions below show how the timeline question is delegated, what the five-working-day window covers, and which four change categories qualify as notifications.

Level	Instrument	Provision	Key point
Technical regulation	RTCR 505:2022	Article 14	Review of registrations, renewals and post-registration changes follows the time limits contained in DE 37988-S
Approving decree	Decreto Ejecutivo N° 43902-S	Article 5	Amends Article 34.2.4.1 of DE 37988-S: notification-type changes are processed in at most 5 working days
Executive decree	DE 37988-S (2013-10-03, La Gaceta N° 203)	Article 34.2.4.1 (as amended)	Para las solicitudes de cambios post registro de EMB con notificación, el Ministerio dispondrá de un plazo de hasta cinco (5) días hábiles…
Technical regulation	RTCR 505:2022	Article 18, first paragraph	Changes require prior approval before implementation, except notification types; four categories are handled by notification
Technical regulation	RTCR 505:2022	Article 18, second paragraph	The four notification categories: label design changes, code cancellation, change or expansion of the local distributor, change of the holder’s address without changing the country of origin
Technical regulation	RTCR 505:2022	Article 10.1	Registrations, renewals and changes are all filed through Regístrelo
Approving decree	Decreto Ejecutivo N° 43902-S	CONSIDERANDO item 12	One purpose of the amendment is to diminish the evaluation period for post-registration changes of the notification type

3. Expert insights

Insight 1: Article 14 is a pointer provision that outsources the timeline question to DE 37988-S. The source text reads: en los plazos que se indican en el Decreto Ejecutivo 37988-S. This drafting technique keeps the technical regulation stable — it does not need amending whenever review efficiency is adjusted — but it also means that the approval cycle cannot be read out of the technical regulation itself. This volume has not obtained the current text of DE 37988-S and therefore states no specific number of days for registration and renewal. The industry-circulated pattern of 15 or 30 working days of legal review, plus 30 days of technical review, plus 10 working days to answer deficiencies, has no supporting official text here and is listed as not adopted. Timelines must be confirmed with the Ministry or the portal before scheduling.

Insight 2: the five-working-day track is strictly confined to notification-type changes, and the regulation lists only four. The second paragraph of Article 18 is explicit: processed by notification are label design changes (18.6), code cancellation (18.7), change or expansion of the local distributor (18.8), and change of the holder’s address without changing the country of origin (18.18). The remaining fifteen categories go through the ordinary approval track and do not benefit from the five-working-day window. Scheduling a non-notification change as if it enjoyed the short track is one of the most common planning errors, and it shows up late, when the approval has not arrived in the expected window.

Insight 3: the approving decree states the legislative purpose of the acceleration. CONSIDERANDO item 12 records that the amendment diminishes the evaluation period of post-registration changes of the notification type, including in Article 5 the modification of Article 34.2.4.1 of Decreto Ejecutivo N° 37988-S. The meaning is that the five working days were deliberately compressed at the time the technical regulation was revised — they are not an inherited custom. When asserting the timeline to internal stakeholders or to the authority, companies can cite this stated purpose directly as the rationale for the short window.

Insight 4: the wording hasta cinco (5) días hábiles — at most five working days — is a ceiling, not a promise. The provision states that the Ministry has a period of up to five working days from receipt of the application to approve it and issue the sanitary registration, or to reject it. The meaning is that the Ministry possesses a processing period of at most five working days within which it may either approve and issue, or reject. Companies should schedule on the basis that a result — approval or rejection — will arrive within five working days, not that approval is guaranteed within five working days. The distinction matters for downstream launches that depend on the filed change.

4. Practical recommendations

Schedule registration and renewal under Article 14 by verifying the current time limits of DE 37988-S with the Ministry of Health or the Regístrelo portal; do not use industry-circulated day counts.
Plan notification-type changes on the five-working-day track, but only for the four listed categories: label design, code cancellation, distributor change or expansion, and holder address change without a change of country of origin.
Plan the remaining fifteen change categories on the ordinary approval track; never apply the five-working-day window to them.
Interpret the limit as at most five working days: the outcome is approval or rejection, not guaranteed approval.
Record the distinction between Article 14 and Article 5 of the approving decree in internal scheduling manuals to prevent the two timelines from being mixed.

5. Verification checklist

□ Article 14 confirmed as a pointer provision (delegating to DE 37988-S)
□ Registration and renewal timelines verified officially; industry day counts not adopted
□ Whether the planned change is one of the four notification categories confirmed (Article 18, second paragraph)
□ Notification-type changes scheduled on the five-working-day track
□ Non-notification changes scheduled on the ordinary track
□ Understood that five working days is a ceiling and the outcome may be rejection

Related reading: [Regístrelo portal filings and digital signature requirements](/costa-rica-medical-device-registration/registrelo-portal-and-digital-signature/) | [Nineteen categories of post-registration changes and four notification items](/costa-rica-medical-device-registration/post-registration-changes-nineteen-categories/) | [Government fees (arancel) and the one-application-one-payment principle](/costa-rica-medical-device-registration/government-fees-and-single-payment-rule/)

Regulatory information verified as of October 29, 2026.

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

Disclaimer

Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.

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