A frequent question we receive from MedTech innovators expanding into Latin America is: "Should we include importer and distributor information on our medical device labeling and Instructions for Use (IFU)?"
The short answer is yes.
Across the region's top markets—Mexico, Colombia, Brazil, Argentina, and Peru—identifying the local responsible entity is not just a "nice-to-have"; it is a strict regulatory requirement enforced by agencies like ANVISA, COFEPRIS, and ANMAT. Failure to include this specific information can lead to stalled shipments at customs or even the rejection of your market authorization.
This guide breaks down the specific labeling requirements for the top five economies in Latin America, helping you ensure compliance and traceability for your medical devices.
🚀 Key Takeaways for Regulatory Teams
Mandatory Requirement: All major LATAM countries require the name and address of the local registration holder, importer, or authorized representative on the label and/or IFU.
Traceability is Key: These laws exist to ensure post-market surveillance and traceability.
Language Matters: Labeling must be in Spanish for Hispanic countries and Portuguese for Brazil.
Registration Holder vs. Distributor: In many cases (like Brazil and Peru), your Registration Holder is the legal entity that must appear, even if you have multiple distributors.
Country-by-Country Labeling Requirements
🇲🇽 Mexico (COFEPRIS)
Regulation: NOM-137-SSA1-2008
In Mexico, COFEPRIS requires strict adherence to labeling standards to ensure the user knows exactly who is responsible for the product locally. The label must explicitly state the registration holder's information.
Required Information:
Name and address of the manufacturer.
Name and address of the importer or distributor.
The phrase "Importado por" (Imported by) or "Distribuido por" (Distributed by).
Sanitary Registration Number (Registro Sanitario).
Language: Spanish.
🇨🇴 Colombia (INVIMA)
Regulation: Decree 4725/2005
INVIMA mandates that all medical devices commercialized in Colombia must ensure traceability through clear identification of the local responsible party.
Required Information:
Name and address of the manufacturer.
Name and address of the Importer or Authorized Representative.
Sanitary Registration Number (Registro Sanitario INVIMA).
Language: Spanish.
🇧🇷 Brazil (ANVISA)
Regulation: RDC 751/2022
Brazil is the largest market in the region and has arguably the strictest surveillance. Under ANVISA rules, foreign manufacturers must appoint a Brazilian Registration Holder (BRH). This entity acts as your legal face in Brazil and must be identified.
Required Information:
Name and address of the legal manufacturer (Fabricante).
Name, address, and CNPJ (tax ID) of the Brazilian Registration Holder (BRH).
The phrase "Importado por" if applicable.
Commercial name and technical information.
Language: Portuguese.
🇦🇷 Argentina (ANMAT)
Regulation: Disposición 2318/02 (Annex III.B)
ANMAT regulations are aligned with MERCOSUR standards. They emphasize the link between the manufacturer and the local importer/registration holder.
Required Information:
Name and address of the manufacturer.
Name and address of the Importer/Registration Holder.
Crucial Detail: If the country of manufacture is different from the country of the Registration Holder, the label must explicitly state the Country of Origin.
Language: Spanish.
🇵🇪 Peru (DIGEMID)
Regulation: DS 016-2011-SA
In Peru, foreign manufacturers cannot register products directly; they must utilize a Peru Registration Holder (PRH). DIGEMID requires this holder's details to be visible to ensure accountability.
Required Information:
Name and address of the PRH or local distributor/representative.
Sanitary Registration Number.
Name and address of the manufacturer.
Language: Spanish.
📊 Summary of Labeling Requirements
Comparison of Medical Device Labeling Importer/Distributor Requirements in Latin America
3 Best Practices for Global Manufacturers
Use "Over-Labeling" Strategically: If you cannot print country-specific cartons for every market, most LATAM countries allow "over-labeling" (placing a compliant sticker over the original box) upon importation into a bonded warehouse, provided it doesn't obscure critical safety information.
Centralize Translation: Ensure your IFUs are translated into "neutral" technical Spanish that is acceptable across Mexico, Colombia, Argentina, and Peru to save costs, while keeping a separate version for Brazil (Portuguese).
Choose Your Holder Wisely: Since your Registration Holder's name must appear on your product, changing them later can require a costly relabeling of your inventory. Selecting an independent registration holder (like bioaccess®) allows you to switch distributors without changing your product labels.
Need Help Navigating LATAM Regulations?
Ensuring your labeling meets local standards is the final hurdle before your technology reaches patients. At bioaccess®, we serve as the in-country regulatory partner for MedTech innovators, managing everything from registration to post-market surveillance.
