Before surgical instruments can be sold in Mexico, they need a sanitary registration (registro sanitario) from COFEPRIS, Mexico’s health regulator. The registration is held by a company in Mexico, usually the importer or distributor. The manufacturer supplies the technical documents.
This is a general guide, not legal advice. Rules change, so check with COFEPRIS or a regulatory consultant in Mexico.
Risk classes
COFEPRIS classes devices by risk: Class I (low), Class II (moderate) and Class III (high). Many surgical instruments are Class I or Class II, depending on the product and its use. Check the class for each product before you apply.
Who holds the registration
A foreign manufacturer cannot hold the registration alone. A company in Mexico must act as the registration holder and take legal responsibility for the product in the Mexican market.
Typical documents
- Certificate of free sale from the country of origin
- Quality system certificate, such as ISO 13485
- Technical description, materials and specifications
- Instructions for use and reprocessing instructions
- Draft labels in Spanish
- Sterilisation validation for sterile products
- Risk analysis
The equivalence route
Since September 2025, devices already approved by recognised regulators, such as the US FDA, Health Canada or the EU (CE marking), can use a faster equivalence route. The product must match the approved model exactly.
Time and cost
COFEPRIS sets official fees for each class, and fees are updated regularly. Review times depend on the class and the route. Plan several months for your first registrations.
How Tata Surgical helps
We prepare the technical documents your registration holder needs. Contact us with the products you want to register.
Looking for instruments like these?
Browse our catalogue or send us your drawing. We reply with prices, lead time and shipping terms.
