On April 4, 2025, the Ministry of Health published NOM-241-SSA1-2025 in the Official Gazette of the Federation, replacing the 2021 version. This standard establishes the minimum requirements for processes…
NOM-241-SSA1-2025
Good Manufacturing Practices for Medical Devices
On April 4, 2025, the Ministry of Health published NOM-241-SSA1-2025 in the Official Gazette of the Federation, replacing the 2021 version. This standard establishes the minimum requirements for the design, development, manufacturing, storage, and distribution processes of medical devices, as well as their establishments, to ensure that they consistently comply with quality standards.
This NOM is harmonized with international benchmarks such as those of the International Medical Device Regulators Forum (IMDRF), thus strengthening the competitiveness of the sector.
Highlights:
Elimination of section 5, referring to the classification of medical devices as a requirement for compliance with good manufacturing practices.
Annual product review. Depending on the nature of the device and the risk analysis, a different frequency for this review may be determined, allowing for greater flexibility in quality control processes.
Specific requirements applicable to retention samples are issued.
For the implementation of Risk Management, please refer to the FEUM Appendix «Application of Risk Management to Medical Devices.»
Specific manufacturing lines are generated for software as a medical device. This reflects the growing importance of software within the sector.
Guidelines on the remanufacturing and refurbishment of medical devices are introduced.
Good storage and distribution practices include specific requirements for relabeling.
Stay informed and ensure compliance to maintain high standards in the medical device industry. If you require further information, please do not hesitate to contact us.