In accordance with Mexican laws, importing a medical device in Mexico requires a valid Import Permit, this document is issued by COFEPRIS.
There are eight different types of Import Permits, the first point to consider is to know if the medical device to be imported has a sanitary registration in Mexico. If so, Case 1 in this text must be chosen. Otherwise, when the medical device does not have a sanitary registration in Mexico or the device is under development, Cases 2 – 8 can be chosen depending on the final use of the medical device.
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.
Type of Import Permits
In this article we focus on describing the main characteristics and requirements rather than explaining the process to get an Import Permit.
A common misunderstanding is that all medical devices with sanitary registration does not require an import permit as well. Even though this type of import permit is only applicable for a certain group of medical devices (some implants or high-risk medical devices) we strongly recommend asking your custom broker or regulatory consulting firm to get the medical device tariff code to make sure if your products will require this permit.
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 holder or by an authorized distributor as well.
For medical devices with sanitary registration containing radiation sources e.g. X-ray machines and radiopaque agents. An additional Import Permit previously issued by the CNSNS is needed.
Case 2 – 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.
Case 3 – Medical devices for personal use
The third case applies only for patients who need a medical device not available in Mexico. The patient must request the import permit directly to COFEPRIS by submitting a valid medical prescription indicating the medical device information and the quantity needed, the import permit will be limited to this quantity.
Case 4 – Medical devices for professional use
The next case is for medical devices intended to be used exclusively by a physician. This kind of import permit is useful for hospitals in need of devices not available in Mexico.
In this case it is the physician who must request this type of permit in behalf of a patient to be treated. Legal requirements such as professional ID must be submitted to COFEPRIS. There are additional requirements when the device to be imported is class II or III or when it is an X-ray device.
Generally, evidence must be presented that there is no comparable technology available in Mexico in order to justify the importation. As in Case 3, this import permit is limited to the number of pieces to be use for a certain patient.
Case 5 – 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.
Case 6 – Medical devices for donations
This case is only available when a foreign organization wish to donate a medical device to public, social or private health institutions. The organization receiving the device in Mexico must request the permit indicating the device that will be imported and assure that this product will not be sold.
Case 7 – Medical devices previously owned
This case is of special interest for importing high end or expensive medical devices. The requirements to submit to COFEPRIS are an invoice proving the device is not new and a document with a statement indicating that the device is working properly.
It is prudent to mention that abuse in requesting this type of import permits has led COFEPRIS to restrict or deny its approval.
Case 8 – 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.
We highlighted the great significance of Case 1 (import permits for medical devices with sanitary registrations) when importing high quantities of medical devices for trade up. In all other cases quantities authorized to import will be very limited and the devices are not always eligible for sale.
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. To get more information about exporting a medical device to Mexico please contact us at firstname.lastname@example.org
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