Changes in Mexican Official Standard NOM-241-SSA1-2012

Changes in Mexican Official Standard NOM-241-SSA1-2012


The Federal Executive through the Ministry of Health establishes the requirements that must be met during the manufacturing process of medical devices that guarantee the quality and functionality of the devices, in order to monitor and safeguard one of the most important points for the population, which is the health of the community.

The implementation of Good Manufacturing Practices (GMP) is a fundamental part of a quality management system, which is a strategic decision of the organization; the design and implementation of the system is influenced by the manufactured product, process, size and structure of the company or organization that decides to carry it out.

The Ministry of Health will exercise sanitary control in manufacturing establishments, conditioning warehouses and distribution of medical devices following the criteria established in the Mexican Official Standard NOM-241-SSA1-2012.

All the requirements of the standard range from the classification of medical devices, organization of an establishment, personnel, documentation, design and construction of an establishment dedicated to the production, to the conditioning, storage and distribution of medical devices.

Likewise, manufacturing control, manufacturing equipment, handling of product out of specifications, returns and complaints, product withdrawal from the market, validation, stability studies, change control, deviations, technical audits, destruction and final destination of contaminating and/or hazardous waste, concordance with international and Mexican standards, conformity assessment and even its validity.

Also based on the changes, needs and vanguard of the world market, the Mexican official standards require changes, so we have been conducting talks, meetings, proposals and projects for these changes.


In the publication of June 14, 2019, the proposed changes are made known, it is a draft Mexican Official Standard PROY-NOM-241-SSA1-2018 Good Manufacturing Practices for medical devices published in the Official Journal of the Federation (DOF ) that marks differences and benefits for some organizations that have already taken the initiative to implement, maintain and certify a management system under either ISO 9001 or ISO 13485. Below is the comparative table:

Mexican Official Standard NOM-241-SSA1-2012, Good manufacturing practices for establishments engaged in the manufacture of medical devices. DRAFT Mexican Official Standard PROY-NOM-241-SSA1-2018, Good manufacturing practices for medical devices.
DOF: 10/11/2012 DOF: 14/06/2019
0. Introduction.

1. Objective and scope of application.

2. References.

3. Definitions.

4. Symbols and abbreviations.

5. Classification of medical devices.

Organization of an establishment.

7. Personnel.

8. Documentation.

9. Design and construction of a post dedicated to the production, packaging, storage and distribution of medical devices.

10. Manufacturing control.

11. Manufacturing equipment.

12. Handling of out-of-specification product (non-conforming product).

13. Returns and complaints.

14. Recall of product from the market.

15. Validation.

16. Stability studies.

17. Change control.

18. Deviations.

19. Technical audits.

20. Destruction and final destination of polluting and/or hazardous waste.

21. Concordance with international and Mexican standards.

22. Bibliography.

23. Enforcement of the standard.

24. Conformity assessment.

25. Validity

0. Intro

0. Introduction.

1. Objective and scope of application.

2. Normative references.

3. Terms and definitions.

4. Symbols and abbreviated terms.

5. Classification of medical devices.

6. Quality Management System.

7. Quality Risk Management.

8. Design and development.

9. Personnel.

10. Facilities and equipment.

11. Qualification and Validation.

12. Manufacturing Systems.

13. Quality Control Laboratory.

14. Release of finished product.

15. Stability studies.

16. Withdrawal of product from the market.

17. Subcontracted activities.

18. Final destination of waste.

19. BPAD.

20. Concordance with international and Mexican standards.

21. Bibliography.

22. Compliance with the standard.

23. Conformity assessment.

24. Validity.

25. Normative Appendix A.




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