Import Guide
Surgical instruments require COFEPRIS registration by risk class. Learn the complete regulatory process.
Most surgical instruments are class II. Implantable ones are class III.
Obtain health registration with safety and efficacy evidence.
Classified under chapter 90 by instrument type and function.
NOM-137 with product data, batch, sterilization, and manufacturer.
COFEPRIS verifies valid registration and documentation at customs.
Tariffs are generally low (0-5%) for surgical instruments.
Tariffs: 0-5% for surgical instruments. Many have 0%. With FTAs: 0%.
Reusable and disposable instruments have different processes
Sterilization must be documented if the product comes sterile
Replacements and accessories may require independent registration
Maintain batch traceability for regulatory compliance