Estándares internacionales para dispositivos médicos

1. Organización Mundial de la Salud (OMS). Fortalecimiento del sistema de reglamentación de los productos médicos [Internet]. 67a Asamblea Mundial de la Salud; Ginebra; 2014 (resolución WHA67.20) [citado 11 de marzo de 2026]. Disponible en: https://apps.who.int/iris/bitstream/handle/10665/170759/A67_R20-sp.pdf.2.

2. World Health Organization (WHO). Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices. Ginebra: OMS; 2017. 68 p.

3. Organización Mundial de la Salud (OMS). Global Benchmarking Tool plus Medical Devices (GBT+Medical Devices) for Evaluation of National Regulatory System of Medical Products [Online]. Ginebra: OMS; 2024 [cited 11 de marzo de 2026]. Available from: https://www.who.int/tools/global-benchmarjing-tools/evaluation-of-national-regulatorysystems-of-medical-devices-in-vitro-dignostic.

4. Organización Mundial de la Salud (OMS). Expert Committee on Biological Standardization:Seventy-sixth report.Technical Report Series No. 1045 [Online]. Ginebra; 2023. Annex 3, WHO Global Model Regulatory Framework for medical devices including in vitro diagnostic medical devices [cited 3 de marzo de 2026]. Available from: https://cdn.who.int/media/docs/default-source/biologicals/ecbs/annex3-gmrfwho_trs_1045.pdf?sfvrsn=88867b3a_3&download=true.

5. International Medical Device Regulators Forum [Online]. 2024 [cited 30 marzo 2026]. Available from: https://www.imdrf.org/.

6. International Medical Devices Regulators Forum. Competence, Training, and Conduct Requirements for Regulatory Reviewers. N 40 [Online]. 2017 [cited 14 marzo 2026]. Available from: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-competence-conduct-reviewers.pdf.

7. International Medical Device Regulators Forum. Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices.IMDRF/GRRP WG/N47 [Online]. IMDRF; 2024 [cited 30 de junio de 2024]. Available from: https://www.imdrf.org/sites/default/files/2024-06/IMDRF%20GRRP%20WG%20N47%20%28Edition%202%29%20%285%29.pdf

8. Global Harmonization Task Force. Principles of Medical Devices Classification. GHTF/SG1/N77 [Online]. 2012 [cited 30 enero de 2026]. Available from: https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n77-2012-principles-medical-devices-classification-121102.pdf.

9. International Medical Devices Regulators Forum. Principles of In Vitro Diagnostic (IVD) Medical Devices Classification. IMDRF/IVD WG/N64 [Online]. 2021 [cited 30 enero de 2026]. Available from: https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-wng64.pdf.

10. Global Harmonization Task Force. Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices. GHTF/SG2/N54R8 [Online]. 2006 [cited 30 enero de 2026]. Available from: https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg2/technical-docs/ghtf-sg2-n54r8-guidance-adverse-events-061130.pdf.

11. International Medical Device Regulators Forum. Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations. IMDRF/SaMD WG/N12 [Online]. 2014 [cited 20 de enero de 2026]. Available from: https://www.imdrf.org/documents/software-medical-device-possible-framework-risk-categorization-and-corresponding-considerations.

12. International Medical Device Regulators Forum. Software as a Medical Device (SaMD): Application of Quality Management System. IMDRF/SaMD WG/N23 [Online]. 2015 [cited 20 de enero de 2026]. Available from: https://www.imdrf.org/documents/software-medical-device-samd-application-quality-management-system.

13. International Medical Device Regulators Forum. UDI Guidance: Unique Device Identification (UDI) of Medical Devices. IMDRF/UDI WG/N7 [Online]. 2013 [cited 21 de febrero de 2026]. Available from: https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-131209-udi-guidance-140901.pdf.

14. Comunidad Europea. Reglamento (UE) 2017/745 del Parlamento europeo y del Consejo de 5 de abril de 2017 sobre los productos sanitarios. Diario Oficial de la Unión Europea [Internet]. 2017 [citado 23 diciembre 2025];17: 1-175. Disponible en: https://www.boe.es/doue/2017/117/L00001-00175.pdf.

15. Comunidad Europea. Reglamento (UE) 2017/746 del Parlamento europeo y del Consejo de 5 de abril de 2017 sobre los productos sanitarios para diagnóstico in vitro. Diario Oficial de la Unión Europea [Internet]. 2017 [citado 23 diciembre 2025];17: 176-330. Disponible en: https://www.boe.es/doue/2017/117/L00176-00330.pdf.

16. Ministry of Public Works and Government Services. Medical Devices Regulations (SOR/98-282). Canada Gazette Part II. 132 (11):1-36.