Import Guide
Medical diagnostic equipment requires COFEPRIS class II registration. Learn requirements for importing lab and diagnostic equipment.
Register equipment as a class II medical device with COFEPRIS.
Confirm manufacturer ISO 13485 certification.
Classify by diagnostic function, technology, and medical application.
Manuals, specifications, diagnostic method validation.
COFEPRIS verifies valid registration and documentation.
Low tariffs for medical diagnostic equipment.
Tariffs: 0-5% for medical diagnostic equipment. Many have 0%. With FTAs: 0%.
Manufacturer ISO 13485 facilitates COFEPRIS registration
Diagnostic reagents may require separate registration
In vitro diagnostic equipment has specific regulation
Maintain authorized service in Mexico