🇪🇨 Ecuador medical device regulatory data

Resolución ARCSA-DE-2024-048-DASP (published Registro Oficial 7, 22-Jan-2025) issued the substitute sanitary technical norm for surveillance and control of advertising and promotion of medicines, processed natural products for medicinal use, homeopathic products and medical devices, in establishments and mass media.

Advertising and promotion of products subject to sanitary control must conform to their true nature, composition, quality and origin so as to avoid any misconception of their qualities or benefits, and this is controlled by the national health authority; advertising by any means of prescription-only medicines is prohibited (device-specific restrictions are set in ARCSA advertising normativa).

The sanitary registration certificate for medical devices is valid for 5 years from grant and renewable for equal periods; the Ley Orgánica de Salud sets a statutory minimum of five years for sanitary registrations/notifications, and the 2026 norm (Art. 17) states the same five-year term.

If re-registration is not requested within the established window and the registration expires, the product may not be imported, manufactured or marketed in Ecuador and a new inscription process must be started.

Re-registration is automatic (no further requirements beyond the request attesting the facts) where the device had no changes in intended use, quality, safety or efficacy during the validity period, was not subject to sanitary alerts or ARCSA suspension, and the request is filed at least 90 days before expiry; otherwise a QMS certificate, a sworn declaration (after alerts/suspension) and documents supporting unapproved modifications must be filed.

Re-registration (reinscripción) requests must be filed at least ninety (90) days before the registration expiry date and not more than six (6) months in advance; requests are filed by the holder through the VUE.

ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria - 'Doctor Leopoldo Izquieta Pérez') is the entidad competente of the National Health Authority that grants, suspends, cancels and re-registers sanitary registrations of medical devices; the Ministerio de Salud Pública holds the rectoría of the health system under the Ley Orgánica de Salud. ARCSA was created by Decreto Ejecutivo 1290 (R.O. S-788, 13-Sep-2012, reformed by Decreto 544, R.O. 428, 30-Jan-2015), whose Art. 10 empowers it to issue technical sanitary norms.

Changes handled by modification rather than new registration include: commercial name; product owner/registration holder/manufacturer changes; name or address changes; model changes not affecting risk or approved characteristics; raw-material composition not affecting risk; packaging material not affecting sterility; commercial presentations; components/accessories; sterilization method; brand; import route; manufacturing process; storage conditions; insert updates; labeling updates; new manufacturing site; new importer/distributor; new items; shelf-life variations. The holder notifies/files these through the VUE modification form with supporting documents per ARCSA instructivo; simpler cases follow the free notification route (NDM list of Resolución ARCSA-DE-2023-005-AKRG).

A new sanitary registration is required for: (a) model change significantly modifying design, functionality or operating principle causing a change of risk level; (b) change of intended use changing the medical purpose and risk level; (c) change of conditions of use/mode of application; (d) changes in chemical composition of raw materials or energy source that change the risk level; (e) change of the qualitative-quantitative formula of formulated devices. When a new registration is granted for these cases, the previous registration is cancelled within 90 days (after any authorized stock exhaustion).

For nationally manufactured devices the holder may not manufacture or market devices incorporating Art. 42 modifications without ARCSA prior approval of those modifications; for foreign-manufactured devices the holder may not import or market devices incorporating modifications when they affect the label and/or insert without prior approval.

Registration of class III and IV devices requires clinical studies or, for SaMD, clinical evaluation specific to the device technology (for DMI, DMA and DMDIV); biofunctionality studies based on scientific evidence and functional performance tests are required for implantable devices of classes III-IV; IVDs of all risk classes require performance studies (precision/repeatability/reproducibility, sensitivity, specificity, and other applicable performance or clinical studies per internationally recognized guidelines).

Devices for human investigations used by specialist practitioners in an adequate clinical research setting, without commercialization purpose, do not require sanitary registration; the Ley Orgánica de Salud separately allows importation of unregistered devices for human clinical research purposes.

The 2026 norm defines in-vitro diagnostic devices (DMDIV) as devices intended by the manufacturer for in-vitro analysis of samples derived from the human body for diagnostic, monitoring or compatibility purposes; combined devices (device + drug in one product) are regulated as medicines when the principal action is pharmacological. Software with machine learning (MLMD) is defined as a device using machine learning wholly or partly to achieve its intended medical purpose.

Ley Orgánica de Salud defines medical devices as articles, instruments, apparatus or mechanical inventions, including components, parts and accessories, made, sold or recommended for use in diagnosis, curative or palliative treatment, prevention of disease, or to replace/modify anatomy or a physiological process; dental amalgams, varnishes and sealants are included.

Imported products must additionally file a Certificate of Free Sale (or equivalent) declaring commercialization, product names/codes, manufacturer and manufacturing sites, and a legalized authorization from the titular del producto empowering the applicant to obtain the Ecuadorian registration with express scope; documents without a stated validity are treated as valid for a maximum of two years from issuance.

Technical documents for registration, modification or re-registration must be in Spanish or English and must be listed in a letter electronically signed by the responsable técnico in Ecuador; the electronic signature must allow authenticity validation under Art. 15 of the Ley de Comercio Electrónico. Labels must be attached as PDF originals (no scans/copies).

Legal documents issued by foreign authorities must be apostilled or consularized (Hague Convention) and presented in Spanish or English; translations by a certified translator are required for other languages. The 2026 norm accepts foreign legal documents without apostille when their content can be verified on the issuing authority's official web portal (with an e-signed letter providing the link), and requires apostille when online verification is not possible.

The dossier must contain, per device type and risk level: batch/serial code explanation and draft labels (all classes), Spanish insert/manual, functional description of components (electromedical/lab equipment), raw-material and packaging descriptions, manufacturing flow diagram, stability study (products with expiry), sterility certificate (sterile devices), manufacturer quality certificate, plus safety/efficacy evidence (biocompatibility, biofunctionality, clinical or SaMD evaluation, IVD performance studies) as triggered by type and class.

Manufacturing and import establishments must have a responsable técnico who is a químico farmacéutico or bioquímico farmacéutico with a degree registered with SENESCYT/CESS; casas de representación (promotion, import and third-party sale of their represented manufacturers' devices) and distribuidoras (import, export and sale) likewise require such technical responsibility and must comply with good storage/distribution/transport practices.

The titular del registro sanitario is the natural or legal person in whose name the sanitary registration certificate is issued and is legally and technically responsible for the quality and safety of the product in Ecuador, including the truthfulness of information given to ARCSA and compliance with manufacturing, storage, distribution, transport and sale rules. Foreign products need a local registration holder holding a valid operating permit (permiso de funcionamiento).

Establishments that store, distribute and/or transport medical devices must hold certification of buenas prácticas de almacenamiento, distribución y/o transporte under the applicable norm (Resolución ARCSA-DE-002-2020-LDCL, whose definitions for casas de representación and distribuidoras are reformed by the 2026 device norm).

Establishments that manufacture, import, distribute, store or market devices and IVD reagents need a valid permiso de funcionamiento issued by ARCSA and may only perform the activities authorized in it; under the Ley Orgánica de Salud the permit is valid for one calendar year, and casas de representación and distribuidoras of devices require a permit from the national health authority (LOS Art. 179).

Imported devices may be conditioned (acondicionamiento) in Ecuador before marketing only in secondary packaging, and only where the establishment holds a valid device BPM certificate or an ARCSA-registered ISO 13485 certificate and is declared as acondicionador in the registration; marking activities require a valid BPA/BPD/BPT certificate. Conditioning/marking must not affect product stability, integrity or primary-container seal.

Inscription, re-registration and modification of device registrations are subject to payment of the amounts set in ARCSA's current fee (tasas) regulations; statutory basis is LOS Art. 138 (the competent entity fixes the charge) and Acuerdo Ministerial No. 112 (R.O. 298, 19-Mar-2008), the regulation for charging for Art. 138 LOS procedures.

Notifications to the sanitary registration (per Resolución ARCSA-DE-2023-005-AKRG) carry no payment, the voluntary cancellation of a registration has no cost, and the modification for risk reclassification ordered by ARCSA under the 2026 norm is free of any charge.

The insert/manual of use must be drafted in Spanish (other languages may additionally be included), is part of the commercial presentation in printed form directed to the user, and is evaluated and approved as part of the registration dossier; minimum content for devices: commercial name, technical specifications, indications/use, mode of use, conservation and presentations; IVD inserts must additionally cover methodology, principle, performance criteria and limitations, specimen, procedure, quality control and precautions.

Labels of primary and secondary packaging of imported and national devices must be in Spanish or English, clearly legible and indelible, and contain at least: commercial name, container content, indications for use, precautions/warnings, storage conditions, manufacturer name-city-country, manufacturing sites, expiry/shelf life when applicable, storage temperature, batch/serial number, registration number and required legends (e.g. 'sterile', 'disposable'). Biomedical equipment is excluded from this list and must be marked per IEC 60601/80601/ISO 80601 (minimum: batch/serial, manufacturer name, brand). Reduced primary-packaging labeling (registration number, name, manufacturer, expiry, lot) is allowed where nature prevents full labeling and the secondary label carries everything.

Resolución ARCSA-DE-2026-003-DASP (signed 28-Apr-2026) issues the substitute Normativa Técnica Sanitaria for registration, control and surveillance of medical devices; it enters into force nine months after signature, i.e. on 2027-01-28.

Resolución ARCSA-DE-026-2016-YMIH (published Registro Oficial Suplemento 921, 12-Jan-2017), as reformed (incl. ARCSA-DE-2023-001-VSVZ and ARCSA-DE-2023-033-AKRG), is the operative sanitary technical norm for medical device registration; it is expressly repealed by Resolución ARCSA-DE-2026-003-DASP when that resolution enters into force.

Registration holders must: implement a Technovigilance Unit (UTV) with one or more health professionals related to device management and inform ARCSA of its creation/changes; report all reportable adverse events from patients, users, health facilities to the UZTV and/or CNTV; receive and channel to the manufacturer/product owner adverse-event notifications; execute post-marketing surveillance of the devices on behalf of the product owner; adopt corrective/preventive measures; and update the registration when technovigilance updates manuals/instructions.

Holders must keep a detailed physical or digital record/archive of all adverse-event reports for at least five (5) years at the establishment, and must keep available the full technical documentation supporting the registration requirements for ARCSA inspection on demand. ARCSA performs risk-based annual post-registration control: Type 1 (visual verification of labels, insert, shelf life and storage vs approved registration) and Type 2 (representative sampling for quality-control analysis at the ARCSA Reference Laboratory).

Within one year of obtaining the registration and before marketing, the holder must file the definitive labels printed with the granted registration number; this filing is made as a notification to the registration (NDM017 under Resolución ARCSA-DE-2023-005-AKRG, as amended by the 2026 norm) and subsequent updates affecting approved definitive labels also follow the notification route.

Registration, re-registration and modification applications are filed online through the Ventanilla Única Ecuatoriana (VUE) of the ECUAPASS portal: log in at portal.aduana.gob.ec, select ARCSA, use form 129-DM-001-REQ-01 (foreign manufacture) or 129-DM-002-REQ-01 (national manufacture), and sign electronically with a digital TOKEN; each form is limited to 100 items (50 for IVDs). Voluntary cancellation and ISO 13485 certificate registration are filed through the Quipux document management system until ARCSA implements a dedicated platform.

National device/IVD-reagent manufacturers must hold a device BPM certificate or an ISO 13485 certificate issued by a conformity-assessment body accredited/recognized by the SAE or designated by the MPCEI, and register that ISO 13485 certificate with ARCSA (application via Quipux, review with two 8-day cure rounds, 10-day payment window); ARCSA publishes the database of registered laboratories. Until ARCSA issues a device BPM norm, classes I-IV national manufacturers rely on the accredited ISO 13485 certificate.

Every registration (all classes, all types) must include a current manufacturer quality-system certificate for the manufacturing site(s): for imported products, ISO 13485 or a rigorously superior certificate; for national manufacturing, a device BPM certificate or an ISO 13485 certificate registered with ARCSA; ISO 9001 is accepted only for teats and feeding bottles (tetinas y biberones).

Suspension or cancellation of a device registration implies prohibition of manufacture, import and export, immediate market withdrawal and seizure of the product (per the Ley Orgánica de Salud). A holder requesting voluntary cancellation must file the request, the appointment document and a market-withdrawal strategy per ARCSA instructivo; ARCSA reviews within 60 days and cancels all associated pending applications; voluntary cancellation is free of charge.

All establishments manufacturing, importing, distributing and marketing devices must have written market-withdrawal procedures and a strategy for rapid, effective recalls; the manufacturer and/or registration holder must notify ARCSA in writing immediately at the start of a withdrawal, keep electronic distribution records available to ARCSA, monitor and record withdrawal progress, issue follow-up reports on ARCSA request, and deliver a final report reconciling quantities delivered, consumed and returned; withdrawn products must be returned to the holder/manufacturer for destruction through authorized waste-management channels, with destruction certificates and dispatch guides. Withdrawal may be voluntary, triggered by a sanitary alert, or mandated by ARCSA (obligatory recall).

No sanitary registration is required for: (a) custom-made (sobre medida) devices; (b) devices used for research in a scientific setting without commercialization purpose; (c) accessories/components/parts and spares that are integral to a registered device, described in its insert, not sold independently and without their own intended use; (d) software that controls or drives a hardware device without an independent medical purpose or integral to its operation. The 2026 norm adds (e) repowered/remanufactured devices.

Devices may be registered under one sanitary registration when they share the same device type, risk level, product owner, manufacturer and intended use; IVDs additionally require the same analytical methodology and analyte group. Sets/kits combining two or more devices for a specific treatment/diagnosis are registered under one number if packaged together; the kit expiry date is that of the component with the shortest shelf life and the kit risk class is that of the highest-risk component.

Manufacture, import, dispensing and marketing of medical devices require a sanitary registration (registro sanitario) granted by ARCSA; the certificate is issued in the name of a registration holder (titular del registro sanitario) and the device obtains a unique national number enabling nationwide marketing. Applications are filed per device through the VUE of the ECUAPASS portal.

Two registration routes exist: (1) ordinary inscription (inscripción general), and (2) simplified inscription (proceso simplificado) based on recognition of registrations from high-vigilance IMDRF-member agencies, which uses a homologation form, a 30-day ARCSA evaluation, and requires the remaining ordinary dossier requirements to be filed within 30 days after approval via a modification request (otherwise the registration is cancelled).

After technical evaluation, objections must be cured within thirty (30) days for nationally manufactured products and sixty (60) days for foreign-manufactured products, with a maximum of two cure rounds; failure automatically cancels the process and a new application with new fee payment is required. The ARCSA technical evaluation time itself varies by risk level, device type and complexity (no fixed total); the simplified route has a 30-day evaluation counted from filing, excluding applicant cure time.

Under the 2026 norm: documentary validation objections must be cured within five (5) days, once only, else the file is automatically cancelled ('solicitud no aprobada'); after a favorable review the payment order must be paid within ten (10) days; failure cancels the process. 'Término' is defined as working days.

Under the operative 2016 norm, ARCSA performs the technical review within ten (10) working days of filing; applicant observations must be corrected within thirty (30) days, with a maximum of two rectifications of the initial application, failing which the process is cancelled. Payment of the fee order is due within ten (10) days.

Resolución ARCSA-DE-016-2020-LDCL (subscribed 2020-07-01, published R.O. Edición Especial 770, 2020-07-13) issues the substitute norm authorizing import by exception and import by donation of medicines, biologicals, medical devices and IVD reagents, covering products without Ecuadorian registration in cases of emergency in the National Health System, state of exception, or international health emergency, and donations with or without registration.

The national health authority, through its competent entity (ARCSA), may authorize importation of devices and IVD reagents that have no Ecuadorian registration: in health emergencies; for patients needing specialized treatments unavailable in the country; for catastrophic, rare or orphan diseases; for human clinical research; for public-sector supply through international organisms; for donations accepted by the health authority; and other defined cases.

Deficiencies are handled by returning the file (trámite) to the applicant for cure: documentary-stage objections get one 5-day cure window (2026 regime) or correction rounds under the current 2016 regime; post-technical-evaluation objections get cure rounds (30 days national / 60 days foreign under the 2026 regime; 30 days with max two rectifications under the 2016 regime). Failure to cure or to pay within the window leads to automatic cancellation with status 'solicitud no aprobada'; a new application with new fee payment is then required and the paid inscription/modification fee is not reimbursed (Art. 18).

Ecuador has no general UDI mandate for medical devices; traceability of implantable devices relies on patient implant identification cards: holders/distributors of implantables must guarantee at least three cards per device (patient, clinical record, distributor/holder), and the implant card must record establishment, patient identification, implant date, ECRI/GMDN code and generic name, commercial name, lot/serial, manufacturer, importer, registration number, and 'UDI, cuando aplique' (UDI when applicable).

For traceability, manufacturers must use international device nomenclature - UMDNS (ECRI) or GMDN - for coding devices (an alternative nomenclature from a high-vigilance agency or WHO is exceptionally allowed when no code exists). ARCSA publishes on its website the updated list of devices with valid, suspended and cancelled sanitary registrations.

Written notification to the UZTV and/or CNTV is due: within 48 hours of confirmation for a serious public health threat; within 10 days for death or serious (temporary or permanent) deterioration of a patient, user or other person; within 30 days for other reportable events. The final follow-up report to the CNTV is due within six months maximum depending on severity, extendable once for an additional equal period on request.

The manufacturer and/or registration holder must investigate each adverse event, establish the causal relationship between the device and the event, and produce an initial investigation report, a follow-up report and a final report in ARCSA formats; the investigation must include a risk evaluation stating whether corrective and preventive actions are needed, which are notified to the CNTV. The CNTV may intervene or open an independent investigation and request information as often as needed.

An adverse event is reportable to the CNTV when three criteria concur: (1) an event occurred in Ecuador with an authorized device (malfunction in intended use, unforeseen events, labeling/instruction inaccuracies, false results causing misdiagnosis, undeclared temporary harm, interactions, design failures discovered on review, serious public health threat, use errors, new literature information); (2) the device is related to the event; (3) the event led or could lead to death, serious injury or serious deterioration of health. Exempt events (defect found before use, patient condition, shelf-life expiry, protection worked, negligible probability, expected/foreseeable events, events described in warnings, CNTV-granted exceptions) are communicated only to the registration holder; trend changes or frequency increases must be notified.

Notifications to the National Technovigilance Center are made in the formats established by ARCSA on its website and sent by email to tecnovigilancia@controlsanitario.gob.ec or through the virtual platform ARCSA uses for the purpose; reporting formats follow PAHO/IMDRF guides and reference/high-vigilance agency annexes. Confidentiality of patient and notifier data is mandatory.