Ministry of Health rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Resolución MS-DM-4164-2025 | Admissibility Procedure for Medical Device Registration Applications Defines the Ministry of Health admissibility and deficiency-prevention procedure for registration submissions covering medicines and biomedical equipment and materials. Ingested from the PGR SINALEVI full-text service (version 1 of 1): the ministerial resolution of 29 July 2025 with its six RESUELVE clauses, repealing Resolución MS-DM-5946-2024; Spanish is the controlling text. | Registration | July 31, 2025 | Official |
| Decreto 43902-S / RTCR 505:2022 | Biomedical Equipment Classification, Registration, Import, Labeling and Vigilance Core Costa Rican technical regulation covering medical device classification, registration, importation, labeling, advertising, vigilance, and market control, including medical software and mobile applications. Ingested from the PGR SINALEVI full-text service as corpus text: Decreto 43902-S articles 1-7 and transitorios I-IV (current through the Decreto 44431 reform of 11 April 2024), the RTCR 505:2022 body as clauses 1-25 under Disposiciones Generales, and normative annexes A (classification rules) and B (equivalence procedure); Spanish is the controlling text. | General | September 10, 2023 | Official |
| Decreto 43789-S | Medical Device Registration Renewal by Notification Establishes the notification procedure used to renew sanitary registrations for Class 2, 3, and 4 biomedical equipment and materials. Ingested from the PGR SINALEVI full-text service (version 2 of 2, the current expression): articles 1-10 ingested as corpus text, article 10 setting vigencia two months after La Gaceta publication; Spanish is the controlling text. | Registration | February 7, 2023 | Official |
Exports carry source + retrieval dateSource-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
The following are processed as notifications (not prior-approval changes): label design change, cancellation of codes, change or expansion of local distributors, and change of the holder's address without change of origin; distributor changes require the new distributor to hold a valid operating permit.
Effective from 2023-09-09
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
Verified guidance on
Read each rule with its scope and conditions.
Changes to registration conditions require approval by the national regulatory authority BEFORE implementation, except changes declared to be notification-type; applications use the Regístrelo post-registration change form digitally signed, plus the requirements listed per change type (holder name change, manufacturer name change, holder change, representative change, product name change/expansion, label design change, code cancellations, local distributor changes, manufacturer change, family/group/system/kit composition change, manufacturing site change, code/model/description change, presentation changes). Each change type carries its own document set and the Decreto 32780 fee.
Effective from 2023-09-09
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
The following are processed as notifications (not prior-approval changes): label design change, cancellation of codes, change or expansion of local distributors, and change of the holder's address without change of origin; distributor changes require the new distributor to hold a valid operating permit.
Effective from 2023-09-09
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
Verified guidance on
Read each rule with its scope and conditions.
Post-registration changes distinguish: change of holder (requires legal document signed by previous and new holder, new representative power, new labels, manufacturing contract, free sale certificate, radiation authorization if applicable, fee) and change of legal representative (requires only the new power of attorney). Both are tramited as post-registration changes, not new registrations.
Effective from 2023-09-09
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
Keep Costa Rica as the target market while you move into registration records, classification, cross-country product research, or pathway planning.
Check a preliminary Ministry of Health risk class.
Inspect public Ministry of Health records.
Search the same product in multiple country registries.
Estimate pathway, government fees, preparation, and review time.
Structure company, product, model, approval, and evidence facts once.
Compare existing evidence against Costa Rica needs.
Connect route, evidence, labels, representatives, and launch dependencies.
Test a current Ministry of Health update against one product and its evidence.
