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Mexican Laws in English
  NOM-241-SSA1-2012, Good Manufacturing practices for establishments dedicated to the manufacure of medical devices.
 
  Published in the DOF October 11, 2012

This Standard to be cancelled and replaced by

NOM-241-SSA1-2021, Good manufacturing practices for medical devices.
which was published in the DOF on December 20, 2021 and takes effect June 20, 2023

 

 

 

This Standard is under the oversight of the SSA = (Secretaría de Salud - Secretary of Health) Environmental Health 

LAW, REGULATION, OR NOM - what is the difference?  

 

NORMA Oficial Mexicana NOM-241-SSA1-2012, Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de dispositivos médicos.

 

Official Mexican Standard NOM-241-SSA1-2012, Good Manufacturing practices for establishments dedicated to the manufacture of medical devices.

INDICE

INDEX

0.         Introducción

0. Introduction

1.         Objetivo y campo de aplicación

1. Objective and Field of Application

2.         Referencias

2. References

3.         Definiciones

3. Definitions

4.         Símbolos y abreviaturas

4. Symbols and abbreviations

5.         Clasificación de los dispositivos médicos

5. Classification of the medical devices

6.         Organización de un establecimiento

6. Organization of an establishment

7.         Personal

7. Personnel

8.         Documentación

8. Documentation

9.         Diseño y construcción de un establecimiento dedicado a la producción, acondicionamiento, almacenamiento y distribución de dispositivos médicos

9. Design and construction of an establishment dedicated to the production, conditioning, storage and distribution of medical devices

10.       Control de la fabricación

10. Manufacturing control

11.       Equipo de fabricación

11. Manufacturing equipment

12.       Manejo de producto fuera de especificaciones (producto no conforme)

12. Handling of product outside of specifications (nonconforming product)

13.       Devoluciones y quejas

13. Returns and complaints

14.       Retiro de producto del mercado

14. Withdrawal of product from the market

15.       Validación

15. Validation

16.       Estudios de estabilidad

16. Stability studies

17.       Control de cambios

17. Control of changes

18.       Desviaciones

18. Deviations

19.       Auditorías técnicas

19. Technical audits

20.       Destrucción y destino final de residuos contaminantes y/o peligrosos

20. Destruction and final destination of contaminating and/or hazardous wastes

21.       Concordancia con normas internacionales y mexicanas

21. Concordance with international and Mexican standards

22.       Bibliografía

22. Bibliography

23.       Observancia de la norma

23. Observance of the Standard

24.       Evaluación de la conformidad

24. Evaluation of conformity

25.       Vigencia

25. Validity

Apéndice normativo A

Obligatory Appendix A

 

$110.00 USD

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