Navigating COFEPRIS: Medical Device Distribution in Mexico

Mexico is one of the largest importers of medical devices in Latin America yet the importation process is highly regulated. To clear customs, you need deep familiarity with the documentation and permitting requirements including abiding the Federal Commision for the Protection against Sanitary Risk (COFEPRIS).

Understanding COFEPRIS for Medical Devices in Mexico

The first step is to obtain a Sanitary Registration Number from the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), the agency that regulates medical devices imported to Mexico. However, completing the sanitary registration process does not automatically clear your device for importation. In this article, we will take a high-level look at the importation process for medical devices in Mexico and the parties involved. 

Key Players in the Medical Device Importation in Mexico 

Foreign device companies importing to Mexico must rely on local representatives to manage regulatory registration and importation. Many steps require expertise with customs laws and documentation, as well as COFEPRIS regulatory medical device requirements, and can only be executed by a Mexican entity. Mexican import laws require you to designate a legal representative in Mexico to manage the importation process and represent your company to government agencies that oversee trade and customs, such as the Tax Administration Service (Servicio de Administración Tributaria (SAT)) and the National Customs Agency (Agencia Nacional de Aduanas de México (ANAM)). This representative can be a customs broker or agent, a company employee residing in Mexico, or another person or entity located in Mexico who acts on behalf of the manufacturer, such as a Mexico Registration Holder (MRH). 

Choosing the Right Mexico Registration Holder

To complete the medical device COFEPRIS registration process, foreign manufacturers must designate an MRH, a person or entity in Mexico who legally represents your company to COFEPRIS during the sanitary registration process and submits your registration dossier to COFEPRIS. Your MRH can manage and apply for import licenses and add or remove distributors from your COFEPRIS registration. The MRH is also the legal sanitary registration owner who will act on your behalf to ensure compliance with post-market requirements and is named on your device labeling. Your MRH should also have experience with importation requirements so they can act as your representative throughout this process. 

Why Distributors and MRH Roles Must Remain Separate for Compliance

Licensed distributors are essential to the importation process, as they will receive, store, and distribute your devices once they clear customs. They should be named on your sanitary registration and maintain compliance with labeling, packaging, and warehousing requirements. However, the distribution and MRH functions are best performed by separate entities.  

Many distributors offer representation and importer services, but there are disadvantages to naming a distributor as your MRH since this means the distributor will own your registration. Distributors may not have the regulatory expertise, personnel, and impartiality regarding their own business interests to fulfill the obligations of this role. However, for an independent MRH, their only business interest is to ensure the regulatory compliance and market success of your device. The registration owner must be able to freely add or remove distributors from your registration when needed, proactively maintain compliance with all post market regulatory obligations, and renew registrations to avoid any disruptions in compliance and importation.  

Overview of COFEPRIS Medical Device Importation Requirements 

The customs requirements for your specific device are dictated by the Harmonized Systems (HS) tariff code. The HS code corresponds to the required permits and documentation, along with the necessary duties and fees, required for your device. Classifying the correct tariff code can be challenging, as more than one tariff code can appear relevant to your device based on its intended use or materials. Your MRH should be able to determine the correct tariff code and identify the applicable customs procedures, fees, and duties, as well as non-tariff regulations and obligations. Companies outside of Mexico must also be registered as an importer in Mexico’s Registry of Importers (Padron de Importadores). 

Once you have obtained a medical device sanitary registration code from COFEPRIS, you must gather other necessary documents to satisfy Mexico’s customs requirements. Specific documentation requirements can vary, but most medical device imports will require the following: 

The import declaration is an essential document that must be completed correctly to successfully clear customs. The required information appears straightforward, such as a description of the device, quantity, HS classification, country of origin, value, weight, and size. However, the information provided must correspond to specific codes referenced by customs officials. The import declaration also serves as evidence that your products were legally imported. As your import representative, your MRH will ensure the documentation provided for import is complete and accurate.

Import Permits for Medical Devices 

You will also need to apply for a medical device importation license from COFEPRIS. COFEPRIS issues several different kinds of importation licenses, including specific licenses for devices intended for use in clinical trials or for personal use. Importation licenses for commercial distribution of devices with sanitary registrations are the most common.

Import permits are requested electronically via the Digital Internatinal Trade Single Window (“VUCEM”) and can take several weeks to process. They are valid for 180 days or until the product quantity approved with the permit has cleared customs. Importation licenses can only be requested by the Mexico Registration Holder (MRH) or a licensed distributor that is named on the sanitary registration.

Learn more about Mexico Medical Device Importation requirements 

Importing a medical device and abiding to COFEPRIS to Mexico is a complex project. But with experienced and knowledgeable in-country representation, foreign medical device manufacturers can clear regulatory and customs hurdles to begin a long-term commercial endeavor. MedEnvoy is a full-service medical device regulatory consulting firm with operations in Mexico. We can act as your Mexico Registration Holder to ensure a seamless partnership for successful registration and importation. 

Please reach out should you need assistance by clicking here and for information about our regulatory experts click here. 

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