Most North Carolina medical device companies entering Mexico are asking about compliance processes before they seriously start to consider sales here. Based on responses we prepare to company inquiries, the key questions we want an NC company to consider are:
- Which registration pathway applies?
- Who will hold the registration?
- What will target customers need to do to procure it?
- Who will import the product?
- What tariff code will be used?
Device Registration
Medical devices sold in Mexico– which can include even low-risk, low-tech supplies if they touch the body– require sanitary registration with COFEPRIS, Mexico’s federal health regulator. US manufacturers may be able to use the “regulatory reliance” COFEPRIS-04-050 registration procedure when their devices already have authorization from a recognized foreign regulator, including the FDA. Otherwise, the standard COFEPRIS-04-060 registration route may apply.
A Mexican entity is generally needed to hold and manage the COFEPRIS registration. In obtaining registration for a family of products, foreign manufacturers might work with a local importer-distributor or a specialized regulatory compliance firm, who become the Mexican entity to whom the device is registered. An example of a compliance firm we have seen in the COFEPRIS device registry database is Emergo by UL.
Registration requires technical and legal documentation, which may include a manufacturer authorization letter, product description and intended use, Spanish labeling and instructions, GMP evidence, a Certificate of Free Sale, and, in some cases, clinical, risk, vigilance, and conformity documentation. Depending on whether a device is Class I, II, or III as related to risk, registration fees range from the equivalent of 1,000-2,000 USD. The permit lasts for five years. Registration applications and follow-up are performed in person.
While specified “response time” is 30-35 days, we take that to currently mean the timeframe for the agency to confirm it is working on a submitted application. COFEPRIS infamously takes up to two years to authorize devices. The cause is apparently structural: a federal mandate that the agency self-fund from fees collected; this inhibits the budget forecasting necessary for operational growth. A recent opinion in El Economista noted that COFEPRIS may be successfully lobbying to change this restrictive funding mechanism.
The National Formulary
Exporters targeting public hospitals should check whether their product has an applicable code in Mexico’s Compendio Nacional de Insumos para la Salud. That is, the national formulary for medical devices, medicines and supplies. While COFEPRIS registration allows a device to be sold legally, lack of an applicable formulary code can make procurement difficult for customers in the public sector. For the public system in Mexico, which is the majority of the market for most devices, formulary codification is as important as getting buy-in, when selling in the US, from insurers. When a marketable therapy is new or innovative, for example biologics, it is especially important to review whether it has a viable code in the formulary.
Importing Devices
Every shipment needs an importer of record established in Mexico. That importer must be properly registered with SAT, Mexico’s tax authority, in SAT’s Padrón de Importadores. In addition, whether the importer of a device is a distributor or a customer, the importing entity must also have filed the appropriate COFEPRIS operating notice. The notice advises the agency of the entity’s standard business activities, whether marketing or administering a therapy, as they relate to healthcare or the healthcare supply chain.
For import permits, Mexican customs uses the product’s tariff classification to determine whether a COFEPRIS import permit is required. This document, updated in 2022 and re-published in 2024, cites which COFEPRIS imports are required for every applicable tariff code. (Mexico’s coding system, TIGIE, is compatible with international HS codes.)
While some tariff classifications for devices call for an import permit, others do not. If a permit is required, it functions to pre-authorize a specified quantity to the receiving importer. The import shipment authorized must be completed within 180 days, whether that is one whole or multiple partial shipments. Exporters should confirm the implications of your tariff code with a qualified customs specialist before shipping to Mexico.
Publicity Registration
As a final regulatory note, promotion of a product to healthcare professionals requires an Aviso de Publicidad, which can be filed online for free with COFEPRIS’s system for simpler procedures, called DIGIPRIS. Advertising a device to the general public requires a separate, prior and more complex authorization from COFEPRIS that is done in person.