Import Guide
Medical devices require COFEPRIS registration based on risk class. Learn the regulatory requirements for importing medical equipment.
Determine the device's risk class (I: low, II: medium, III: high). This defines the regulatory process.
Obtain health registration. Class I requires listing; Class II and III require full registration.
Medical devices are classified under chapter 90 by function and technology.
Comply with NOM-137-SSA1 with product and importer information in Spanish.
COFEPRIS may verify documentation and product at customs.
Present valid COFEPRIS registration and complete the import process.
Tariffs: 0-10% for most medical devices. Diagnostic and surgical equipment generally 0-5%. With FTAs: 0%.
COFEPRIS registration can take 3 to 12 months depending on risk class
Class III (implantables, life support) requires the most rigorous process
Maintain a health responsible with professional license
Medical consumables may have simplified registration