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WTO notification · TBT

EcuadorAdopted, according to its latest notice

Medical equipment, Pharmaceutical products

Draft 'Sanitary Technical Regulation for obtaining the certificate of requirement or non-requirement of the sanitary notification of processed foods, pesticides or mandatory sanitary notification of cosmetics and hygiene products, and certificate of requirement or non-requirement of sanitary registration of medicines, natural products, medical devices and biochemical reagents'

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Proyecto de 'Normativa Técnica Sanitaria para la obtención del certificado de requerimiento o no de la notificación sanitaria de alimentos procesados, plaguicidas o notificación sanitaria obligatoria de cosméticos y productos higiénicos, y certificado de requerimiento o no de registro sanitario de medicamentos, productos naturales, dispositivos médicos y reactivos bioquímicos'

Ecuador issued an addendum on 8 January 2026 to the earlier TBT notification G/TBT/N/ECU/508. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 25 August 2021. The comment period closed on 24 October 2021.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

Published here:

Updated here:

At a glance

Products

Draft 'Sanitary Technical Regulation for obtaining the certificate of requirement or non-requirement of sanitary notification of processed foods, pesticides or mandatory sanitary notification of cosmetics and hygienic products, and certificate of requirement or non-requirement of health registration of m

View original

Proyecto de 'Normativa Técnica Sanitaria para la obtención del certificado de requerimiento o no de la notificación sanitaria de alimentos procesados, plaguicidas o notificación sanitaria obligatoria de cosméticos y productos higiénicos, y certificado de requerimiento o no de registro sanitario de m

Notifying member
Ecuador
Status
Adopted, according to its latest notice
Objectives
  • Prevention of deceptive practices and consumer protection
  • Protection of human health or safety
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/ECU/508Latest notice: G/TBT/N/ECU/508/Add.4
ICS classification
  • 11.040 Medical equipment
  • 11.120 Pharmaceutics
  • 65.100 Pesticides and other agrochemicals
  • 67.230 Prepackaged and prepared foods
  • 71.100.70 Cosmetics. Toiletries
Keywords
Human health

Key dates

Distributed by the WTO
Comment deadline
Closed on 24 October 2021
Proposed adoption
Desde 60 días a partir de la notificación
Proposed entry into force
180 días a partir de la fecha de adopción

What the notification says

Latest notice (⁨G/TBT/N/ECU/508/Add.4⁩, 8 January 2026)

The latest notice says the measure was adopted or published.

Partial amendment to the Sanitary Technical Regulation for obtaining the certificate of requirement or non-requirement of health registration, sanitary notification or mandatory sanitary notification of products for human use and consumption subject to control and surveillance by the National Agency for Regulation, Control and Sanitary Surveillance (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria, ARCSA), Doctor Leopoldo Izquieta Pérez

View original

Reforma Parcial a la Normativa Técnica Sanitaria para la obtención del certificado de requerimiento o no del registro sanitario, notificación sanitaria o notificación sanitaria obligatoria de productos de uso y consumo humano sujetos a control y vigilancia de la Agencia Nacional de Regulación, Control y Vigilancia Sanitaria - ARCSA, Doctor Leopoldo Izquieta Pérez (Partial amendment to the Sanitary Technical Regulations for obtaining the certificate indicating whether or not health registration,

The Republic of Ecuador hereby notifies Resolution ARCSA-DE-2025-047-DASP, issuing the partial amendment to the Sanitary Technical Regulations for obtaining the certificate 1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final/modified measure and/or interpretative guidance can be obtained.G/TBT/N/ECU/508/Add.4- 2 - indicating whether or not health registration, a health notification or a mandatory health notification is required for products for human use and consumption subject to control and surveillance by the National Agency for Health Regulation, Control and Surveillance (ARCSA), Doctor Leopoldo Izquieta Pérez. The notified Resolution incorporates the definitions of Reagent for In Vitro Use (RUO/IUO) and Laboratory Developed Test (LDT), establishes the requirements applicable to such products, and updates the validity of the certificate indicating whether or not health registration/a health notification/a mandatory health notification (RS/NS/NSO) is required.Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries)Subsecretaría de la Calidad (Under-Secretariat for Quality)Primary enquiry point:Cristian Eduardo Yépez JaramilloPlataforma Gubernamental de Gestión FinancieraAv. Amazonas entre Unión Nacional de Periodistas y Alfonso PereiraPiso 8Bloque amarilloQuito EC170522Tel.: (+593 2) 3948760, Ext…

This sanitary technical regulation establishes the procedure for obtaining the certificate of requirement or non-requirement of the sanitary notification of processed foods, pesticides or mandatory sanitary notification of cosmetics and hygiene products, and certificate of requirement or non-requirement of sanitary registration of medicines, natural products, medical devices and biochemical reagents; in order to know if the product is subject to obtaining the aforementioned certificates. This sanitary technical regulation applies to all natural or legal persons, national or foreign, that relate to or intervene in the processes mentioned in the previous article of this sanitary technical regulation.

View original

La presente normativa técnica sanitaria establece el procedimiento para la obtención del certificado de requerimiento o no de la notificación sanitaria de alimentos procesados, plaguicidas o notificación sanitaria obligatoria de cosméticos y productos higiénicos, y certificado de requerimiento o no de registro sanitario de medicamentos, productos naturales, dispositivos médicos y reactivos bioquímicos; con el fin de conocer si el producto está sujeto a la obtención de los certificados antes mencionados. La presente normativa técnica sanitaria aplica a todas las personas naturales o jurídicas, nacionales o extranjeras que se relacionen o intervengan en los procesos mencionados en el artículo anterior de la presente normativa técnica sanitaria.

Notices on this measure

Every notice about this measure published here, newest first. Each one is the notifying member's own text.

  1. AddendumG/TBT/N/ECU/508/Add.4

    Partial amendment to the Sanitary Technical Regulation for obtaining the certificate of requirement or non-requirement of health registration, sanitary notification or mandatory sanitary notification of products for human use and consumption subject to control and surveillance by the National Agency for Regulation, Control and Sanitary Surveillance (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria, ARCSA), Doctor Leopoldo Izquieta Pérez

    View original

    Reforma Parcial a la Normativa Técnica Sanitaria para la obtención del certificado de requerimiento o no del registro sanitario, notificación sanitaria o notificación sanitaria obligatoria de productos de uso y consumo humano sujetos a control y vigilancia de la Agencia Nacional de Regulación, Control y Vigilancia Sanitaria - ARCSA, Doctor Leopoldo Izquieta Pérez (Partial amendment to the Sanitary Technical Regulations for obtaining the certificate indicating whether or not health registration,

    The Republic of Ecuador hereby notifies Resolution ARCSA-DE-2025-047-DASP, issuing the partial amendment to the Sanitary Technical Regulations for obtaining the certificate 1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final/modified measure and/or interpretative guidance can be obtained.G/TBT/N/ECU/508/Add.4- 2 - indicating whether or not health registration, a health notification or a mandatory health notification is required for products for human use and consumption subject to control and surveillance by the National Agency for Health Regulation, Control and Surveillance (ARCSA), Doctor Leopoldo Izquieta Pérez. The notified Resolution incorporates the definitions of Reagent for In Vitro Use (RUO/IUO) and Laboratory Developed Test (LDT), establishes the requirements applicable to such products, and updates the validity of the certificate indicating whether or not health registration/a health notification/a mandatory health notification (RS/NS/NSO) is required.Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries)Subsecretaría de la Calidad (Under-Secretariat for Quality)Primary enquiry point:Cristian Eduardo Yépez JaramilloPlataforma Gubernamental de Gestión FinancieraAv. Amazonas entre Unión Nacional de Periodistas y Alfonso PereiraPiso 8Bloque amarilloQuito EC170522Tel.: (+593 2) 3948760, Ext…

  2. AddendumG/TBT/N/ECU/508/Add.3

    Partial amendment to the Sanitary Technical Regulation for obtaining the certificate of requirement or non-requirement of health registration, sanitary notification or mandatory sanitary notification of products for human use and consumption subject to control and surveillance by the National Agency for Regulation, Control and Surveillance (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria, ARCSA)

    View original

    Reforma Parcial a la Normativa Técnica Sanitaria para la obtención del certificado de requerimiento o no del registro sanitario, notificación sanitaria o notificación sanitaria obligatoria de productos de uso y consumo humano sujetos a control y vigilancia de la Agencia Nacional de Regulación, Control y Vigilancia Sanitaria - ARCSA (Partial amendment to the Sanitary Technical Regulations for obtaining the certificate indicating whether or not health registration, a health notification or a manda

    The Republic of Ecuador hereby notifies the partial amendment to the Sanitary Technical Regulations for obtaining the certificate indicating whether or not health registration, a health notification or a mandatory health notification is required for products for human use and consumption subject to control and surveillance by the National Agency for Health Regulation, Control and Surveillance (ARCSA).This document has a comment period of 60 days from the date of notification on the WTO ePing platform.Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries)Subsecretaría de Calidad (Under-Secretariat for Quality)TBT Enquiry PointPrimary enquiry point:Cristian Eduardo Yépez JaramilloPlataforma Gubernamental de Gestión FinancieraAv. Amazonas entre Unión Nacional de Periodistas y Alfonso PereiraPiso 8Bloque amarilloQuito EC170522Tel.: (+593 2) 3948760, Ext. 2254; Ext. 2252Email: puntocontacto-otcecu@produccion.gob.ec; puntocontactoecu@gmail.com; cyepez@produccion.gob.ecWebsite:

  3. AddendumG/TBT/N/ECU/508/Add.2

    Reforma parcial a la 'Normativa Técnica Sanitaria para la obtención del certificado de requerimiento o no de la notificación sanitaria de alimentos procesados, plaguicidas o notificación sanitaria obligatoria de cosméticos y productos higiénicos, y certificado de requerimiento o no de registro sanitario de medicamentos, productos naturales, dispositivos médicos y reactivos bioquímicos' (Partial amendment to the 'Sanitary Technical Regulation for obtaining the certificate indicating whether or no

    Partial amendment to the 'Sanitary Technical Regulation for obtaining the certificate indicating whether or not the sanitary notification for processed foods and pesticides or the mandatory sanitary notification for cosmetics and hygiene products is required, and the certificate indicating whether or not sanitary registration for medicines, natural products, medical devices and biochemical reagents is required' By means of this Addendum No. 2, the Republic of Ecuador advises that the 'Sanitary Technical Regulation for obtaining the certificate indicating whether or not the sanitary notification for processed foods and pesticides or the mandatory sanitary notification for cosmetics and hygiene products is required, and the certificate indicating whether or not sanitary registration for medicines, natural products, medical devices and biochemical reagents is required' has been issued pursuant to Resolution No. ARCSA-DE-2022-020-AKRG of 29 December 2022 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez). The Regulation will enter into force on the date of its signature, without prejudice to its publication in the Official Journal. Text available from: Ministerio de Producción, Comercio Exterior, Inversiones y Pesca (Ministry of Production, Foreign Trade, Investment and Fisheries), Subsecretaría de Calidad (Under-Secretariat for Quality), Organismo Nacional de Notificación (National Notification Authority) TBT…

  4. AddendumG/TBT/N/ECU/508/Add.1

    Sanitary Technical Regulation for obtaining the certificate indicating whether or not the sanitary notification for processed foods and pesticides or the mandatory sanitary notification for cosmetics and hygiene products is required, and the certificate indicating whether or not sanitary registration for medicines, natural products, medical devices and biochemical reagents is required

    Sanitary Technical Regulation for obtaining the certificate indicating whether or not the sanitary notification for processed foods and pesticides or the mandatory sanitary notification for cosmetics and hygiene products is required, and the certificate indicating whether or not sanitary registration for medicines, natural products, medical devices and biochemical reagents is required By means of this Addendum No. 1, the Republic of Ecuador advises that the 'Sanitary Technical Regulation for obtaining the certificate indicating whether or not the sanitary notification for processed foods and pesticides or the mandatory sanitary notification for cosmetics and hygiene products is required, and the certificate indicating whether or not sanitary registration for medicines, natural products, medical devices and biochemical reagents is required' has been issued pursuant to Resolution ARCSA-DE-2022-001-JPFJ of 10 January 2022 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez). The Regulation will enter into force on the date of its signature, without prejudice to its publication in the Official Journal. Text available from: Ministerio de Producción, Comercio Exterior, Inversiones y Pesca (Ministry of Production, Foreign Trade, Investment and Fisheries), Subsecretaría de Calidad (Under-Secretariat for Quality), Organismo Nacional de Notificación (National Notification Authority) TBT enquiry point: Jeannette Mariño…

  5. Regular notificationG/TBT/N/ECU/508

    Comment deadline: Closed on 24 October 2021

    Draft 'Sanitary Technical Regulation for obtaining the certificate of requirement or non-requirement of the sanitary notification of processed foods, pesticides or mandatory sanitary notification of cosmetics and hygiene products, and certificate of requirement or non-requirement of sanitary registration of medicines, natural products, medical devices and biochemical reagents'

    View original

    Proyecto de 'Normativa Técnica Sanitaria para la obtención del certificado de requerimiento o no de la notificación sanitaria de alimentos procesados, plaguicidas o notificación sanitaria obligatoria de cosméticos y productos higiénicos, y certificado de requerimiento o no de registro sanitario de medicamentos, productos naturales, dispositivos médicos y reactivos bioquímicos'

    This sanitary technical regulation establishes the procedure for obtaining the certificate of requirement or non-requirement of the sanitary notification of processed foods, pesticides or mandatory sanitary notification of cosmetics and hygiene products, and certificate of requirement or non-requirement of sanitary registration of medicines, natural products, medical devices and biochemical reagents; in order to know if the product is subject to obtaining the aforementioned certificates. This sanitary technical regulation applies to all natural or legal persons, national or foreign, that relate to or intervene in the processes mentioned in the previous article of this sanitary technical regulation.

    View original

    La presente normativa técnica sanitaria establece el procedimiento para la obtención del certificado de requerimiento o no de la notificación sanitaria de alimentos procesados, plaguicidas o notificación sanitaria obligatoria de cosméticos y productos higiénicos, y certificado de requerimiento o no de registro sanitario de medicamentos, productos naturales, dispositivos médicos y reactivos bioquímicos; con el fin de conocer si el producto está sujeto a la obtención de los certificados antes mencionados. La presente normativa técnica sanitaria aplica a todas las personas naturales o jurídicas, nacionales o extranjeras que se relacionen o intervengan en los procesos mencionados en el artículo anterior de la presente normativa técnica sanitaria.

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

All updates from Ecuador
  1. WTO notificationSPSProposed measure, open for comments

    Proposed measure from Ecuador: goods in 3 HS chapters

    Ecuador notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 25 December 2026.

    Symbol: G/SPS/N/ECU/402Comments until 25 December 2026

  2. WTO notificationSPSProposed measure, open for comments

    Proposed measure from Ecuador: live plants

    Ecuador notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 13 November 2026.

    Symbol: G/SPS/N/ECU/401Comments until 13 November 2026

  3. WTO notificationSPSProposed measure, open for comments

    Proposed measure: Ecuador

    Ecuador notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 13 November 2026.

    No products listed by the notifying member

    Symbol: G/SPS/N/ECU/400Comments until 13 November 2026

  4. WTO notificationSPSProposed measure, open for comments

    Proposed measure: Ecuador

    Ecuador notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 13 November 2026.

    No products listed by the notifying member

    Symbol: G/SPS/N/ECU/399Comments until 13 November 2026

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