WTO notification · TBT
EcuadorAdopted, according to its latest notice
Draft Sanitary Technical Regulation for the sanitary registration and control of medical devices for human use, and of the establishments where they are manufactured, stored, distributed and marketed (25 pages, in Spanish)
Proyecto de Normativa técnica sanitaria para el registro sanitario y control de dispositivos médicos de uso humano, y de los establecimientos en donde se fabrican, almacenan, distribuyen y comercializan (Draft Sanitary Technical Regulation on the sanitary registration and control of medical devices for human use, and of the establishments that manufacture, store, distribute or market such devices) (25 pages, in Spanish);
Ecuador issued an addendum on 26 May 2026 to the earlier TBT notification G/TBT/N/ECU/325. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 3 May 2016. The comment period closed on 2 July 2016.
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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:
9.018.90.10
9.018.90.10
Latest notice (G/TBT/N/ECU/325/Add.5, 26 May 2026)
The latest notice says the measure was adopted or published.
Substitute Technical Health Regulations concerning the health registration, control and surveillance of medical devices for human use
The Republic of Ecuador has issued Resolution ARCSA-DE-2026-003-DASP, containing the Substitute Technical Health Regulations concerning the health registration, control and surveillance of medical devices for human use. The text was signed on 28 April 2026 and will enter into force nine months from that date, i.e. on 28 January 2027.It should be noted that, in compliance with the transparency principle of the World Trade Organization (WTO), the draft Regulations were notified on 29 October 2025, on the WTO's ePing and the Andean Community's SIRT platforms, providing a period of 60 days for comments.__________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.
The notified draft Technical Regulation covers the following: Purpose and scope; Definitions and abbreviations; Sanitary registration of medical devices for human use; Obtaining sanitary registration; Packaging, labelling and inserts/user manuals; Re-registration and changes to the sanitary registration of medical devices for human use; Other authorizations; Importation; Marketing and promotion; Operating permits for pharmaceutical establishments relating to medical devices for human use; Monitoring and control; and Penalties.;
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/ECU/325/Add.5
Substitute Technical Health Regulations concerning the health registration, control and surveillance of medical devices for human use
The Republic of Ecuador has issued Resolution ARCSA-DE-2026-003-DASP, containing the Substitute Technical Health Regulations concerning the health registration, control and surveillance of medical devices for human use. The text was signed on 28 April 2026 and will enter into force nine months from that date, i.e. on 28 January 2027.It should be noted that, in compliance with the transparency principle of the World Trade Organization (WTO), the draft Regulations were notified on 29 October 2025, on the WTO's ePing and the Andean Community's SIRT platforms, providing a period of 60 days for comments.__________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.
AddendumG/TBT/N/ECU/325/Add.4
Draft Substitute Technical Health Regulations concerning the health registration, control and surveillance of medical devices for human use
Proyecto 'Normativa Técnica Sanitaria Sustitutiva para la obtención del registro sanitario, control y vigilancia de dispositivos médicos de uso humano' (Draft Substitute Technical Health Regulations concerning the health registration, control and surveillance of medical devices for human use)
The Republic of Ecuador notifies that the National Agency for Health Surveillance, Regulation and Control (ARCSA - Doctor Leopoldo Izquieta Pérez) is in the process of issuing the draft Substitute Technical Health Regulations concerning the health registration, control and surveillance of medical devices for human use. These will replace the guidelines set out in Resolution ARCSADE-026-2016-YMIH, issuing the Substitute Technical Health Regulations concerning the health registration and control of medical devices for human use, and of the establishments that manufacture, import, dispense, sell or market such devices, published in the Official Journal Supplement No. 921 of 12 January 2017, and amendments thereto. Agency: Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries) Subsecretaría de Calidad (Under-Secretariat for Quality) Primary enquiry point: Cristian Eduardo Yépez Jaramillo Plataforma Gubernamental de Gestión Financiera Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Piso 8 Bloque amarillo Quito EC170522 Tel.: (+593 2) 3948760, Ext. 2254/ 2252 Email: puntocontacto-otcecu@produccion.gob.ec; puntocontactoecu@gmail.com; cyepez@produccion.gob.ec Website: __________
AddendumG/TBT/N/ECU/325/Add.3
REFORMA PARCIAL A LA NORMATIVA TÉCNICA SANITARIA SUSTITUTIVA PARA EL REGISTRO SANITARIO Y CONTROL DE DISPOSITIVOS MÉDICOS DE USO HUMANO, Y DE LOS ESTABLECIMIENTOS EN DONDE SE FABRICAN, IMPORTAN, DISPENSAN, EXPENDEN Y COMERCIALIZAN (Partial amendment to the Substitute Sanitary Technical Regulation on the sanitary registration and control of medical devices for human use and of the establishments that manufacture, import, dispense, sell or market such devices)
The notified text partially amends the Substitute Sanitary Technical Regulation on the sanitary registration and control of medical devices for human use and of the establishments that manufacture, import, dispense, sell or market such devices. By means of this Addendum No. 3, the Republic of Ecuador advises that the Partial amendment to the Substitute Sanitary Technical Regulation on the sanitary registration and control of medical devices for human use and of the establishments that manufacture, import, dispense, sell or market such devices has been issued pursuant to Resolution No. ARCSA-DE-2023-033-AKRG of 10 November 2023 of 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: Eduardo Yépez Plataforma Gubernamental de Gestión Financiera - Piso 8 Bloque amarillo Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Quito, Ecuador Tel.: (+593-2) 3948760, Ext. 2252/2254 Email: Puntocontacto-OTCECU@produccion.gob.ec cyepez@produccion.gob.ec __________
AddendumG/TBT/N/ECU/325/Add.2
By means of this Addendum No. 2, the Republic of Ecuador advises that 'Sanitary Technical Regulation for medical devices', notified in document G/TBT/N/ECU/325 of 3 May 2016, has been issued pursuant to Resolution No. ARCSA-DE-033-2017-FMRH of 26 December 2017 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA), published in Official Journal No. 156 of 9 January 2018. Text available from: Ministerio de Industrias y Productividad (Ministry of Industry and Productivity
AddendumG/TBT/N/ECU/325/Add.1
By means of this Addendum No. 1, the Republic of Ecuador advises that the 'Substitute Technical and Sanitary Regulation on the sanitary registration and control of medical devices for human use and of the establishments that manufacture, import, dispense, sell or market such devices', notified in document G/TBT/N/ECU/325 of 3 May 2016, was issued pursuant to Resolution No. 26 of 12 December 2016 of the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA), published in Offici
Regular notificationG/TBT/N/ECU/325
Comment deadline: Closed on 2 July 2016
Draft Sanitary Technical Regulation for the sanitary registration and control of medical devices for human use, and of the establishments where they are manufactured, stored, distributed and marketed (25 pages, in Spanish)
Proyecto de Normativa técnica sanitaria para el registro sanitario y control de dispositivos médicos de uso humano, y de los establecimientos en donde se fabrican, almacenan, distribuyen y comercializan (Draft Sanitary Technical Regulation on the sanitary registration and control of medical devices for human use, and of the establishments that manufacture, store, distribute or market such devices) (25 pages, in Spanish);
The notified draft Technical Regulation covers the following: Purpose and scope; Definitions and abbreviations; Sanitary registration of medical devices for human use; Obtaining sanitary registration; Packaging, labelling and inserts/user manuals; Re-registration and changes to the sanitary registration of medical devices for human use; Other authorizations; Importation; Marketing and promotion; Operating permits for pharmaceutical establishments relating to medical devices for human use; Monitoring and control; and Penalties.;
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
WTO notificationSPSProposed measure, open for commentsNew
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
WTO notificationSPSProposed measure, open for commentsNew
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
WTO notificationSPSProposed measure, open for commentsNew
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
WTO notificationSPSProposed measure, open for commentsNew
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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