🇨🇷 Costa Rica medical device regulatory data

EMB advertising must comply with the 'Reglamento para la autorización y control sanitario de la publicidad de productos de interés sanitario' in force (Decreto N° 36868-S, cited on the Ministry's advertising trámite page). Per that official trámite page, prior Ministry review/approval applies only to advertising of prescription-only medicines and foods covered by Ley 7430 (breast-milk substitutes) — not to EMB advertising generally. Advertising products without registration is a minor infraction; advertising uses differing from the registered ones, misleading advertising, creating false expectations, and promoting professional-use EMB to the general public are grave infractions.

Personal-use IVDs for detecting HIV, HTLV, hepatitis B/C/D or other sexually transmitted agents, or detecting an infectious agent in cerebrospinal fluid or blood, are not authorized by the Ministry for sale to the public, and mail-order/telematic sale of unregistered EMB or products under the numeral 24 prohibition is a very-serious-category advertising/sales infraction.

EMB sanitary registration is valid for five years, without prejudice to the Ministry's cancellation or modification powers under Ley N° 5395 (Ley General de Salud).

Decreto 43789-S establishes renewal of EMB registration by notification for classes 2, 3 and 4 (not available where post-registration changes are pending in Regístrelo): the applicant files the form, a sworn declaration of no changes, payment receipt and (for imports) a free sale certificate authenticated and legalized by the Costa Rican consulate in the country of origin; resolution is granted expeditiously upon complete submission and the renewed registration is valid five years from approval; the fee equals the registration fee.

Renewal grants a period equal to the initial registration; before expiry the holder or legal representative must file via Regístrelo: renewal form, current legal representative power (if expired/absent), manufacturing contract (if third-party manufacture and expired/absent), sworn declaration that product conditions have not changed, GMP certificate, valid operating permit (national products), free sale certificate (imported products), label (if not in file), radiation authorization where applicable, animal-tissue biological safety certificate where applicable, and the Decreto 32780 fee.

The Ministerio de Salud de Costa Rica is the national regulatory authority (Autoridad Reguladora Nacional) responsible for the regulation, registration and control of medical devices (equipo y material biomédico, EMB). Registration processing sits with the Dirección de Regulación de Productos de Interés Sanitario.

The Centro Nacional de Tecnovigilancia (CNTV), seated in the corresponding Ministerio de Salud organizational unit, coordinates the National Tecnovigilance System and receives adverse-event reports for medical devices.

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.

The original 6-month transition to file a post-registration change submitting the product label (if not already in the sanitary registration file) was extended by a 2024 reform to eighteen months counted from the entry into force of that reform.

A change to the product that entails a variation in risk classification is considered a new product and requires a new registration (per class requirements in numerales 11/12/13); a change of specific use (indication) that implies a change in risk classification also requires a new registration; all other post-registration changes follow numeral 18.

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.

Class 3 and 4 registrations require clinical evidence composed of the manufacturer's clinical evaluation document, preclinical studies where applicable, human clinical studies (or, for well-established technology, third-party studies on the product or a similar product with a manufacturer equivalence declaration and supporting evidence), software validation study where applicable, bibliographic studies, and a risk analysis/evaluation summary; class 4 additionally requires published post-market reports.

For IVDs, comparative investigative performance tests performed on the EMB using human samples representative of intended users under conditions similar to expected use may be submitted as clinical evidence, accompanied by a declaration by the product holder attesting to the truthfulness of results.

Equipo y Material Biomédico (EMB): any instrument, device, equipment, material or other article, used alone or in combination (including software involved in its operation), intended by the manufacturer for human use for diagnosis, prevention, control, treatment or alleviation of disease; injury/deficiency compensation; investigation, replacement or modification of anatomy or a physiological process; or conception control, plus products used to clean, condition, disinfect or sterilize an EMB, provided the principal action is not pharmacological, immunological or metabolic. Aesthetic-treatment equipment, non-corrective contact lenses and permanent-makeup/tattoo instruments are included as EMB.

In-vitro diagnostic devices (Equipo para diagnóstico "in vitro") are EMB including their reagents, calibrators, controls and consumables intended to examine or diagnose from samples or fluids obtained from the human body; IVDs that contain a medicine or serve as internal quality controls (including blood-derivative-based) are expressly in scope.

Software as Equipo Médico is software intended for medical purposes performing those purposes without being part of a physical device; it is an EMB (including IVD software), can run on general-purpose computing platforms, and mobile apps meeting the definition are considered Software as Equipo Médico. Accessories and medical software receive identical treatment to EMB.

RTCR 505:2022 does not apply to medicines, human blood/blood products, cosmetics, human organs/tissues/cells and products made from them, general laboratory articles used only for research (unless intended by the manufacturer for IVD diagnosis), internationally certified reference materials, external quality assessment materials, and medical gas piping assembled on site. A product intended to administer a medicine is regulated under RTCR 505:2022 (the medicine under CA medicines rules); if device and medicine form an integrated single-use product, the medicines regulation applies. Peritoneal dialysis fluids and contrast media are classified as medicines, not EMB.

Class 2 EMB registration requires: Regístrelo application form digitally signed; valid operating permit (national products) or Certificate of Free Sale (imported products, legalized/apostilled with official translation when not in Spanish, plus notarial certification); original technical and medical specifications, manuals and inserts as marketed (with translation if not Spanish); GMP certificate of the manufacturer or its equivalent in the country of origin (see QMS fact); radiation source authorization where applicable; original label (or complementary label project); manufacturing contract for contract manufacture; legal representative power; payment of the Decreto 32780 fee; for IVDs, a document identifying the applicable international accuracy/precision standard.

Class 3 EMB must additionally submit detailed clinical evidence demonstrating safety and efficacy: clinical evaluation document by the manufacturer; preclinical studies if applicable; clinical studies in humans (where the manufacturer conducted none due to well-established technology, third-party studies on the product or on a similar product with an equivalence declaration and supporting evidence are accepted); software validation study if applicable; bibliographic studies; and a risk analysis/evaluation summary. Class 3 IVDs may instead/also submit comparative performance studies on representative human samples under expected-use conditions with a truthfulness declaration by the holder.

Class 4 EMB must additionally submit: copy of the risk analysis and evaluation study with risk-reduction measures prepared by the manufacturer; bibliographic references of published post-marketing reports on use, safety and efficacy; and, for devices made from animal tissues or derivatives, a manufacturer certificate demonstrating biological safety.

All registration documents must be in Spanish (official translation for legal/official documents; simple translation of the original labeling); every official/legal document issued abroad must be legalized or apostilled with a digitally signed notarial certification (or per Decreto 37988-S); all information has the character of a sworn declaration (declaración jurada); official certificates must be valid at submission and, where validity is not stated, are considered valid for 2 years from issuance; corrections in certifications are not allowed unless supported by the issuing authority.

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.

The holder or its legal representative may authorize third parties to import or distribute the product (distribuidores autorizados), either in the registration application or through a post-registration change.

If the product holder does not reside in Costa Rica, it must appoint by power of attorney a legal representative (representante legal) domiciled in Costa Rica, who is legally answerable to the authority; the power must state validity and granted powers, conform to the issuing country's law, be in Spanish (or with official translation) and be legalized or apostilled.

The titular del producto is the natural or legal person owning an EMB marketed under a specific name or brand, legally answerable to the national regulatory authority; the holder is responsible for the device's safety and efficacy and must hold objective evidence available to the authority on request.

The manufacturer (for domestically manufactured products) or the importer (for foreign products) must hold a valid sanitary operating permit (permiso sanitario de funcionamiento) matching its activity; the importer is defined as a person entering the country EMB manufactured abroad holding the respective valid operating permit. For national products the permit must state 'fabricación de Equipo y Material Biomédico' as activity.

Personal-use in-vitro diagnostic EMB may only be sold by mail order or telematic procedures through establishments holding a Ministry of Health permit for their commercialization.

A single application (trámite) implies a single fee payment, even where multiple products are grouped (family, group, family of groups, system, test kit, multiple presentations).

Per the official labeling guide, the complementary label must be placed on the smallest commercial package (the package the final consumer receives) and must be affixed before commercialization by the distributor inside the EMB storage warehouse; class 1 products, being exempt from registration, do not carry a registration number and may state on the label that they are exempt (exonerado de registro).

EMB labels must show: true specific product name; intended purpose/use; name or tradename/logo and country of the holder; name or tradename/logo and country of the manufacturer; product identification code (or declared model); lot number; package content description; expiry date or shelf life; 'sterile' indication when declared; special storage conditions; symbols and warnings where applicable; instructions for safe use (or reference to insert/manual); personal-use indication; single-use indication; 'producto a la medida' legend for custom-made products; for personal-use IVDs the legend that the self-test is only orientative; EMB registration number (not applicable to exempt products); and for research-only IVDs the corresponding exclusive-research-use legend.

EMB labeling must contain the required information in Spanish; if the original label is in another language, a complementary (supplementary) label translating the mandatory information is permitted, and it may also be used to add mandatory information missing from the original Spanish label; inserts and manuals accompanying the product as marketed must be in Spanish. Registration documents must be in Spanish (official translation for legal documents).

Medical devices are governed by technical regulation RTCR 505:2022 (classification, registration, importation, labeling, advertising, vigilance and control), approved by Decreto Ejecutivo N° 43902-S; it repealed most articles of the former Decreto N° 34482-S (2008) and any reference to 34482-S in other rules is read as a reference to 43902-S.

Satellite instruments referenced by RTCR 505:2022: Decreto 37988-S (Regístrelo portal, incl. review deadlines), Decreto 32780 (EMB fees), Decreto 39342-S (Sistema Nacional de Tecnovigilancia), Decreto 24037-S (ionizing radiation protection), Decreto 43789-S (renewal by notification), Decreto 36868-S (advertising of products of sanitary interest), Decreto 43896-S (market withdrawal/recall).

Registrations approved before RTCR 505:2022 entered into force remain valid until their original expiry.

Manufacturers, importers and distributors must prepare and send periodic EMB safety reports to the CNTV: every 6 months during the first 2 years of marketing in the country; every year from the second to the fifth year; and every 5 years from the fifth year onward.

Manufacturers, importers and distributors must design and implement an Institutional or Company Tecnovigilance Unit to identify, record, evaluate and manage adverse event reports for the EMB they market, designate a trained health professional as the unit's responsible person before the CNTV, and communicate to the CNTV international alerts associated with devices they market and actions taken; the designated responsible person must be communicated to the CNTV and kept current.

The application form must be digitally signed by the product holder or its legal representative or a person authorized by the representative; digitally signed documents must meet Banco Central integrity, authenticity and time-validity standards.

All registration, renewal and post-registration-change applications must be filed through the Regístrelo platform (www.registrelo.go.cr), a 24/7 online single window connecting the public institutions involved, governed by Decreto 37988-S; users must register in the Regístrelo user registry with a digital certificate and make payments through the system.

The dossier must include a manufacturer GMP certificate (or its equivalent in the country of origin) issued by that country's health authority or authorized entity, covering all establishments involved in any lifecycle stage (design/development, production, storage/distribution, installation, technical support). However, Transitorio I of Decreto 43902-S suspends this requirement until a national EMB GMP regulation exists; Transitorio IV ordered the Ministry to issue that GMP regulation within 12 months of entry into force.

Every recall (voluntary or Ministry-ordered) must be executed within no more than 30 business days from identification of the problem unless the Ministry sets a different period (extensions requested before expiry; Ministry answers within 14 calendar days); the responsible party must submit a final report (form Anexo 2) within 20 business days after completion reconciling distributed and retrieved quantities with root-cause investigation; for Class I/II recalls reaching user/consumer level, consumers must be informed through a public medium in the form, content and term set by the Ministry.

The Ministry may order market withdrawal of products of sanitary interest that fail regulatory requirements or pose a public-health risk, evaluate recall scope/classification/timeframes, inspect or audit recall effectiveness, and for imported/exported Class I/II recalls exchange information with international authorities. Separately, on knowledge of any adverse or harmful event endangering public health related to EMB use, the Ministry may order market withdrawal as a precautionary measure, suspend or cancel the registration, and bar imports (Decreto 43902-S Artículo 3º; Ley 5395 arts. 355/356/362 basis cited in Decreto 43896-S).

Any voluntary recall meeting Class I or Class II criteria must be notified to the Ministry using the website form signed as sworn declaration, within a maximum of 5 business days from identification of the problem, defect or situation; the responsible party must adopt the recall measure and communicate it to the other establishments in the commercialization chain within a maximum of 5 business days.

Class 1 EMB do not require sanitary registration for marketing and use, but import, labeling, advertising, vigilance and control requirements still apply to them. The Ministry trámite page cites Decreto N° 41387-S for the class 1 exemption; class 1 products may state on the label that they are exempt.

One application may cover multiple presentations of a product, dilutions of the same pure product, a test kit, an EMB family, a group of EMB, a family of groups, or a system, provided the specific use does not vary; a single registration number is assigned and a single trámite implies a single payment. Adding members or changing composition requires a post-registration change; products with different composition require separate registrations.

All EMB may only be manufactured, imported, marketed or distributed in Costa Rica if they hold the respective sanitary registration; applications for registration, renewal and post-registration changes are filed through the Regístrelo platform (www.registrelo.go.cr). Classes 2-4 register; class 1 is exempt from registration.

Donations of EMB are within the regulation's scope, and any use of a donated EMB that has not been approved by the Ministry of Health under the established requirements and procedures is prohibited.

Sanitary authorizations for customs release (desalmacenaje) of unregistered EMB exclusively for clinical research purposes are excluded from the application of RTCR 505:2022.

Users of the Regístrelo portal must designate an e-mail address as their permanent electronic domicile for receiving notifications on proceedings managed in the system (Art. 14). A notification to the electronic domicile or subsidiary medium takes effect on the business day following its reception, and legal deadlines run from the business day after notification (Art. 15). Regístrelo may additionally communicate the status of each proceeding by e-mail or SMS, which does not exempt the user from the duty to track the proceeding in the portal (Art. 16).

For EMB registration the Ministry has up to two months (odontología devices) or four months (microbiología and medicina devices) from receipt of the application to approve it and issue the sanitary registration, or to reject it. No-change renewals by sworn declaration are resolved within twenty natural days; renewals with changes within one, two or three months by category; and post-registration changes within one month for notification-type changes.

EMB labels must bear the product identification code (or declared model), the lot number, and the EMB registration number except for products exempt from registration.

Manufacturers, importers and distributors must implement a traceability system to follow EMB through the commercialization, supply and use chain, with special emphasis on implantables, available for CNTV consultation; for implantable EMB a system must guarantee completion and registration of the traceability form so the implanted device can be identified throughout the person's life.

Information on all adverse event and incident reports (serious and non-serious) must be presented quarterly in consolidated form by the manufacturer's, importer's or distributor's tecnovigilance responsible to the local Áreas Rectoras de Salud, regional Direcciones Regionales de Rectoría de la Salud, or the CNTV, including preventive/corrective measures proposed or executed; non-serious events are reported quarterly by the designated responsible. Failure to report leads to a sanitary order (orden sanitaria) and, if not complied with, cancellation of the sanitary registration.

Serious adverse events and incidents (those that may lead to or endanger life or cause serious deterioration of health, including life-threatening disease or injury, damage to bodily function or structure, conditions requiring medical/surgical intervention to prevent permanent damage, incapacitating events) must be reported to the CNTV within 24 hours of occurrence or from the moment knowledge is obtained.