Post-Registration Changes Nineteen Categories

1. Key takeaways

Article 18 of RTCR 505:2022 in Costa Rica enumerates post-registration changes exhaustively in 19 categories (18.1 to 18.19), of which only 4 are handled as a notification (notificación) — label design changes (18.6), code cancellation (18.7), change or addition of local distributors (18.8), and change of the holder’s address without changing the country of origin (18.18); the remaining 15 must go through the approval route. The notification deadline is 5 working days under Article 5 of the approving decree, which rewrites Article 34.2.4.1 of DE 37988-S. The GRZAN regulatory team notes: two items recur in almost every category — the new labels under Article 11.7 and the payment voucher at the official fee rate — and these are what domestic companies most often omit.

• The 19 categories are an exhaustive positive list, not an open authorisation; match each change to its category first.
• The four notification categories share one feature: none touches the technical or safety substance of the product.
• New labels under Article 11.7 and the official-fee payment voucher appear in nearly every category and are the commonest omission.
• Only two categories trigger clinical evidence: changes of intended use (18.14.2) and of medical specifications (18.15.2) for Clase 3 and Clase 4 under Article 12.2.
• The catch-all 18.19 applies only where the certificate content is not modified and the change fits none of the first 18 categories.

2. Legal basis

The change regime sits in RTCR 505:2022, as approved by Decreto Ejecutivo N° 43902-S of 30 November 2022, with procedural rules from the approving decree and DE 37988-S, and one provision rewritten by the 2024 amendment.

3. Expert insights

Insight one: The 19 categories form a positive list, not an open authorisation. Article 18 enumerates them: 18.1 change of the holder’s trade name; 18.2 change of the manufacturer’s trade name; 18.3 change of holder; 18.4 change of the holder’s legal representative; 18.5 change or addition of the product name; 18.6 label design change; 18.7 code cancellation; 18.8 change or addition of local distributors; 18.9 change of manufacturer; 18.10 change of the family, group, family group, system or kit composition; 18.11 change of manufacturing site or address; 18.12 change of identification code, model or description; 18.13 change of technical specifications, manuals, catalogues or instructions for use; 18.14 change or addition of intended use; 18.15 change of medical specifications; 18.16 simultaneous change of holder and manufacturer; 18.17 version change; 18.18 change of the holder’s address (without changing country of origin); 18.19 others. Match the change to its category first, then assemble the documents.

Insight two: The four notification categories share one feature: none touches the technical and safety substance of the product. 18.6 only changes the label design; 18.7 cancels a code rather than adding one; 18.8 changes the channel entity; and 18.18 states expressly sin cambio de origen (no change of country of origin). Once a change crosses this line — for example, an 18.18 situation that also changes the country of origin — it leaves the notification channel, returns to approval, and triggers the dossier completion obligation of Article 18.11.4.

Insight three: The new labels and the payment recur across the 19 categories. Provisions 18.1.2, 18.2.3, 18.3.3, 18.5.1, 18.6.1, 18.9.3, 18.10.4, 18.11.5, 18.12.4, 18.13.3, 18.14.3, 18.15.3 and 18.16.4 all require nuevas etiquetas según lo indicado en el numeral 11.7 (new labels as indicated in Article 11.7); the final item of subcategories such as 18.1.3, 18.2.4 and 18.3.7 is payment. Omitting either item gets the package returned.

Insight four: Only two categories of change trigger clinical evidence. Article 18.14.2 (change or addition of intended use) and Article 18.15.2 (change of medical specifications) require Clase 3 and Clase 4 products to submit clinical evidence under Article 12.2 supporting the new use or new medical specifications. Clase 2 is not included, which draws a clear line.

Insight five: The three-part requirement for documents issued abroad matches first registration. Articles 18.12.2, 18.13.2 and 18.18.1 all state that documents issued abroad must be legalised or apostilled (apostilla), that non-Spanish documents must carry an official translation, and that a notarised certification of the digital signature must be attached; documents issued by domestic entities may use the legal representative’s digital signature. These requirements share the same source as Article 10.17 and are not relaxed because the filing is a change.

Insight six: The boundary of the catch-all category 18.19 must be read carefully. The original wording limits it to cambios que no impliquen modificaciones en el certificado de registro — as long as the change does not modify the content of the registration certificate and fits none of the first 18 categories, this item may be used; the documents are only a statement and justification of the change (18.19.1) plus payment (18.19.2). Anything that would alter the certificate content cannot take this shortcut.

4. Practical recommendations

• Classify before drafting: compare the intended change against Articles 18.1 to 18.19 to confirm its category; where two or more categories are involved (for example, changing both manufacturer and holder), file under 18.9 and 18.16 together rather than splitting into two packages.
• Determine notification versus approval with one question: does the country of origin change, and does the technical or safety substance change? If neither changes and the matter falls within 18.6, 18.7, 18.8 or 18.18, treat it as a notification with an expected 5 working days; otherwise leave schedule margin for approval.
• Make labels and payment standard actions: put the new labels under Article 11.7 and the payment voucher at the official rate into the template for every category of change, to avoid case-by-case omission.
• Prepare clinical evidence early for Clase 3 and Clase 4 use and medical specification changes: Articles 18.14.2 and 18.15.2 point to the six evidence items of Article 12.2, whose preparation cycle is longer than the administrative one.
• Complete the three-part requirement for foreign-issued documents in one pass: legalisation or apostille, official Spanish translation, and notarised certification of the digital signature — all three are indispensable and must match the filer.
• Maintain a change ledger: log every change by category number, acceptance number, approval date and effective label version; renewal (Article 16) and verification (Article 22) both consult this record.

5. Verification checklist

• □ The category of the intended change has been confirmed against Articles 18.1 to 18.19
• □ The change has been determined as notification or approval (does it change the country of origin or the technical and safety substance)
• □ New labels under Article 11.7 have been prepared (including Spanish mandatory items)
• □ The payment voucher at the official rate is ready, with the amount per the official schedule current at acceptance
• □ The six clinical evidence items of Article 12.2 are complete for Clase 3 and Clase 4 use or medical specification changes
• □ Foreign-issued documents carry legalisation or apostille, official translation and notarised certification of the digital signature
• □ Simultaneous changes of manufacturer and holder have been filed under Article 18.16 rather than split as 18.3 and 18.9
• □ The change ledger records the category, acceptance number and effective label version

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