Good manufacturing practices for medical devices
Establishes Good Manufacturing Practice requirements for establishments engaged in the manufacture and import of medical devices.
Last updated: 2024-10-05
Determine the risk class of the medical device (I, II, or III) per Mexican regulations.
Compile technical documentation, quality certificates, and required clinical evidence.
Submit the registration application to COFEPRIS with the complete file.
Ensure labeling complies with NOM-137-SSA1 in Spanish.
Obtain the import permit and complete customs clearance with all documentation.
Device seizure, fines up to 300,000 UMA, sanitary registration cancellation, establishment closure.
Camtom helps you identify and comply with all applicable regulations for your imports.