Importing medical devices, requires a valid Import Permit, this document is issued

by COFEPRIS and thus there are different types of import permits. The first to
consider is medical devices and has to be a sanitary registration with COFEPRIS.

The medical device importation in Mexico is a highly regulated activity. To

successfully import a device, the right type of Import Permit must be chosen, and
all requirements must be submitted to COFEPRIS.

At the same time there are eight different types of import permits to consider.

General Characteristics

Every Import Permit described below share the following characteristics:

Must be requested to COFEPRIS using the VUCEM system.

Takes around 3-5 weeks to be released upon submission to COFEPRIS.

Valid for 180 days or to the number of pieces approved in the permit.

After reaching such limit another permit must be requested.

Most commonly used Import Permits

Medical devices with sanitary registration

It is worth mentioning that this is the most common Import Permit requested to
COFEPRIS because it is used on regular basis by all the companies to import a
broad variety of medical devices in large quantities intended to be sold. This kind of
Import Permit must be requested by the sanitary registration or by an authorized
distributor as well.

Import permits are required even if there is a sanitary registration with Cofepris.

Medical devices for third party manufacturing

In this case a medical device, is temporary imported for a third-party manufacturing

process at any stage. An authorization issued by the Secretary of Economy
or IMMEX code is required.

Medical devices for human subject research

This type of import permit is requested by research centers, universities and

private organizations (e.g. Clinical Research Organizations) to import medical
devices that will be used in clinical research studies performed in humans or when
a medical device is under development and will be tested in Mexican patients. An
essential requirement to get this import permit is to hold a clinical research
protocol approved by COFEPRIS.

Medical devices for laboratory testing

The last case of import permit is for medical devices that will be used in laboratory
tests not involving humans.

Importation of lab samples and kits covered under the human research protocol 3.1.4. Legal
entities that carry out the definitive importation regimen of samples covered under a human
research protocol, approved by COFEPRIS, must declare the tariff fraction with their NICO
9801.00.01 00 .