Importing Medical Devices into Mexico: COFEPRIS

Last updated: October 10, 2026

Medical devices are among the most regulated goods in Mexico. Before import, the product needs authorization from the health authority (COFEPRIS), and customs checks that the pedimento, the tariff classification and the permits match. This guide covers what to review before the first shipment.

1. Sanitary registration

Medical devices are classified by risk (class I, II or III). Requirements and approval times increase with the class.
The sanitary registration is held by a company established in Mexico (manufacturer, distributor or representative).
Without a valid sanitary registration, the product cannot be sold in Mexico.

2. Sanitary import permit

Many devices also need a COFEPRIS sanitary import permit.
Documents usually requested: sanitary registration, certificate or letter of free sale from the country of origin, the manufacturer’s good manufacturing practices certificate, technical data sheet and invoice.

3. Applicable standards

NOM-241-SSA1: good manufacturing practices for medical devices.
NOM-137-SSA1: medical device labeling, in Spanish.
Also check whether your tariff classification carries other NOM standards or regulations in the NOM Annex.

4. At customs

The pedimento must declare the right tariff classification and the sanitary permit data.
Description, model and part number must match the sanitary registration and the label.
Inconsistencies hold the goods and can force relabeling or return.

Manufacturing in Mexico for export

Many plants in Mexico make medical devices under IMMEX for export to the United States, where FDA has its own establishment registration and device listing requirements. We coordinate the U.S. entry and the Mexican pedimento on the same shipment. See also Annex 24 and USMCA rules of origin.

Related guides: Mexican NOM standards · Mexico tariff classification · all trade guides

Frequently asked questions about medical devices

Who holds the sanitary registration?

A company established in Mexico: the manufacturer, a distributor or a representative. Without a valid sanitary registration, the product cannot be sold in Mexico.

Besides the registration, do I need an import permit?

In many cases, yes. Many devices need a COFEPRIS sanitary import permit. The usual documents are the sanitary registration, the certificate of free sale from the country of origin, the manufacturer’s good manufacturing practices certificate, the technical data sheet and the invoice.

What labeling does a medical device need?

Spanish labeling under NOM-137-SSA1. Also check whether your tariff classification carries other NOM standards or regulations.

Why does a medical device get held at customs?

Almost always because the data does not match. Description, model and part number must be the same on the pedimento, the sanitary registration and the label. A difference can force relabeling or return of the goods, which is why we review the documents before the shipment.

Do you handle devices made in Mexico for export to the United States?

Yes. Many plants make them under IMMEX. In the United States, FDA requires establishment registration and device listing. We coordinate the U.S. entry and the Mexican pedimento on the same shipment.