ARCSA market access

Ecuador medical device registration resources

Research ARCSA registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Ecuador medical device resource.

254,292 registration records11 free resources24/25 topics with records4 regulations trackedAug 2026 fees reviewed

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Medical device registration database

Search official ARCSA device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official ARCSA regulations and guidance documents.

Government registration fees

Review current ARCSA application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely ARCSA pathway, government fees, dossier preparation time, review timeline, and registration steps.

AI medical device classifier

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Ecuador requirements.

AI similar registered product finder

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Medical device regulation news

Follow recent ARCSA policy, guidance, safety, and compliance updates.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

Compare ARCSA published response times with realistic approval times by route.

Structured regulatory requirements

Explore all 57 source-linked facts →

24 of 25 research dimensions currently covered · 12 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified

Competent authority: 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, can…

1 source-linked fact

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

2026 substitute norm and entry into force: 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…
Current device registration norm: 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…

2 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

IVD and combined-product scope: 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…
Statutory device definition: 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…

2 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

Risk classes I through IV.: Class I, Class II, Class III, Class IV

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Products not requiring registration: 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/co…
Grouping and sets/kits: 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…

4 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

Future ARCSA simplified route: dual authority conditions; NMPA eligibility unconfirmed: statement: From 28 January 2027, Articles 31 32 require both high vigilance authority status and IMDRF membership, plus the stated device marketing/class conditions. IMDRF membership alone…
China NMPA approval: origin evidence only: statement: From 28 January 2027, ARCSA DE 2026 003 Article 25(a) accepts a Certificate of Free Sale (CLV), or qualifying equivalent, from the country of manufacture/export, a high vigilance…

4 source-linked facts

Checked 2026-09-15

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D07

Economic-operator roles

Verified

Technical responsible professional: 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 repres…
Registration holder responsibility: 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 an…

2 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Good storage/distribution practice certification: 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 (…
Establishment operating permit: 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 auth…

3 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Additional requirements for imported products: Imported products must additionally file a Certificate of Free Sale (or equivalent) declaring commercialization, product names/codes, manufacturer and manufacturing sites, and a legalized a…
Dossier language and electronic signature: 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 Ecuado…

4 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Definitive label filing after approval: 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 notific…
Filing portal and forms: 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 AR…

2 source-linked facts

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

IFU language and content: 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 evalu…
Label language and minimum content: 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 con…

2 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

ARCSA registration of ISO 13485 certificates (national manufacturers): 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 designate…
QMS and audit evidence for market access: 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 su…

2 source-linked facts

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

ARCSA electrical/EMC evidence: Electrical safety
ARCOTEL terminal-equipment homologation: Wireless / radio
Radiation/legal metrology: Radiation

3 maintained overlays

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D14

Fees

Verified

Domestic medical-device registration: USD 678.30
Foreign medical-device registration: USD 904.34

6 maintained fee lines · 2 related facts

Checked 2026-08-25

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D15

Review clocks

Verified

Standard registration (all classes) · ARCSA sanitary registration through the VUE single window: 152 working days
Recognition route (all classes) · Simplified registration recognising an IMDRF high-surveillance authority approval: 95 working days

2 maintained pathways · 3 related facts

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Authorization duration: 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 f…
Expiry or lapse consequence: 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 pr…

4 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Modification (no new registration) categories: Changes handled by modification rather than new registration include: commercial name; product owner/registration holder/manufacturer changes; name or address changes; model changes not aff…
New-application triggers: 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…

3 source-linked facts

Checked 2026-08-26

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D18

UDI, listing & traceability

Verified

Implant cards and UDI applicability: Ecuador has no general UDI mandate for medical devices; traceability of implantable devices relies on patient implant identification cards: holders/distributors of implantables must guarant…
Nomenclature requirement and public registration registry: 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 except…

2 source-linked facts

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical/performance evidence by class: 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 bas…
Investigational devices outside registration: Devices for human investigations used by specialist practitioners in an adequate clinical research setting, without commercialization purpose, do not require sanitary registration; the Ley…

2 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Exceptional/donation import regulation: 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…
Exceptional import 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 p…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Holder post-market obligations: 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 rep…
Record retention and post-registration control: 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 doc…

2 source-linked facts

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Reporting deadlines: 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) deterio…
Investigation reports: 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 rep…

4 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Suspension/cancellation effect and voluntary cancellation: 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 Sa…
Market withdrawal duties: All establishments manufacturing, importing, distributing and marketing devices must have written market withdrawal procedures and a strategy for rapid, effective recalls; the manufacturer…

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

ARCSA advertising normativa covering devices: 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 medi…
Statutory advertising control: 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 b…

2 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Deficiency handling and consequence: 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 curre…

1 source-linked fact

Checked 2026-08-25

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Government fees

Full fee schedule (6 lines) →

ARCSA registration fees in USD · reviewed 2026-08-25

Fee line	Amount	Provenance
Domestic medical-device registration	USD 678.30	Verified
Foreign medical-device registration	USD 904.34	Verified
Domestic medical-device re-registration (reinscripción)	USD 135.66	Verified
Foreign medical-device re-registration (reinscripción)	USD 180.87	Verified

2 more fee lines on the full schedule · 6 of 6 rows source-verified

Registration timeline

Full registration timeline →

National Agency for Regulation, Control and Sanitary Surveillance (ARCSA) review clocks and planning ranges · 4-class (I, II, III, IV) classification

Class / pathway	Review clock	Planning total	Provenance
Standard registration (all classes)(ARCSA sanitary registration through the VUE single window)	152 working days	8-14 months	Verified
Recognition route (all classes)(Simplified registration recognising an IMDRF high-surveillance authority approval)	95 working days	5-9 months	Verified