Regulatory affairs teams with an FDA 510(k) or a CE certificate in hand often arrive in Latin America with the same expectation: the clearance should open doors. Sometimes it does. Sometimes it is one document in a full review. The difference is whether the country has a written reliance pathway, what that pathway accepts, and whether your approval qualifies.
I’m Julio Martinez-Clark, CEO of bioaccess®. We register and hold medical devices across Latin America. This article compares the three markets most device companies start with, Brazil, Mexico and Colombia, and separates what reliance shortens from what it doesn’t.
The short answer
- Brazil (ANVISA) has a formal reliance procedure for Class III and IV devices under Instrução Normativa (IN) 290 of 4 April 2024, based on prior approval by a recognized equivalent foreign regulatory authority.
- Mexico (COFEPRIS) has recognized foreign approvals for devices since 2010 and moved to a broader reliance model in 2025, with general guidelines for the abbreviated regulatory pathway published in the Diario Oficial de la Federación on 18 July 2025.
- Colombia (INVIMA) does not run a formal abbreviated equivalency pathway for devices. An FDA or CE approval is mandatory evidence in the file, not a substitute for INVIMA’s review.
Why reliance spread across the region
Reliance means a regulator takes into account the work of a trusted reference authority instead of repeating it. The World Health Organization published good reliance practices guidance in 2021, and the Pan American Health Organization has promoted reliance across the Americas as a way for agencies with limited review staff to focus on what is local: labeling, the in-country holder, vigilance and the specific population.
Reliance is not recognition of a foreign approval as if it were a local one. In every country below, the local agency keeps the final decision, and can send your file back to ordinary review.
Brazil: IN 290/2024 and the equivalent foreign authority route
IN 290/2024 sets an optimized procedure for primary registration petitions of medical devices, including in vitro diagnostics, in risk Classes III and IV. It is issued under ANVISA’s general reliance resolution, RDC 741/2022, and sits on top of the device framework in RDC 751/2022 (and RDC 830/2023 for IVDs). ANVISA started applying it in June 2024.
What you need to know:
- Reference authorities. ANVISA lists its equivalent foreign authorities (AREE) for devices on its reliance page: Health Canada, the US FDA, Japan’s MHLW and Australia’s TGA. A CE certificate alone is not one of them.
- Essentially identical device. The device must have the same essential characteristics as the one the reference authority approved: specifications, composition, indications and intended use, manufacturer, manufacturing process and safety and performance results.
- Ordinary reference approval. Under Article 4, devices that the reference authority authorized through an abbreviated route similar to ANVISA’s optimized procedure do not qualify. They go through the ordinary pathway.
- Classes I and II. These generally follow the notificação route under RDC 751/2022 and are not the target of IN 290.
Reliance shortens the technical review. It does not remove the Brazilian registration holder, Portuguese labeling and instructions for use, the ANVISA good manufacturing practice certification for Class III and IV, or INMETRO certification for electromedical equipment where it applies. Those are often the real critical path.
Mexico: from equivalence acuerdos to the 2025 abbreviated pathway
Mexico was early. An acuerdo published in the Diario Oficial on 26 October 2010 recognized FDA and Health Canada device approvals as equivalent to Mexican requirements for sanitary registration. A second acuerdo, published on 25 January 2012 and in force from 24 February 2012, added Japan’s MHLW and PMDA approvals and registered certification bodies.
In 2025 COFEPRIS widened this into a general reliance model. The general guidelines for the abbreviated regulatory pathway (vía regulatoria abreviada), published on 18 July 2025, set uniform eligibility and documentation rules for medicines and devices based on decisions of reference regulatory authorities. For devices, the reference set is tied to IMDRF member authorities and the Medical Device Single Audit Program.
Points that catch teams:
- Identical product. The product must keep the essential characteristics approved by the reference authority.
- Valid reference approval. The foreign authorization must be in force when you file and for the life of the Mexican registration.
- Ordinary approvals only. Reference approvals granted through something other than an ordinary review cannot support the request.
- The local titular. In Mexico, the local registration holder (titular) owns the sanitary registration number. Choose that party with care, because changing it later is its own procedure.
- Labeling. Spanish labeling still has to meet NOM-137-SSA1-2008.
COFEPRIS keeps its surveillance powers, and registrations granted this way carry the same legal effect, and the same tecnovigilancia duties, as ordinary ones.
Colombia: evidence, not equivalency
Colombia regulates devices under Decreto 4725 de 2005, with its own Class I, IIa, IIb and III scheme. A US Certificate to Foreign Government or a Certificate of Free Sale from a recognized reference market is required evidence. It does not convert into an INVIMA registration.
Practical consequences:
- Classify the device under Colombian rules. A US Class II product code does not map automatically.
- Class I and IIa files can receive a registration on a complete submission, with technical review still possible afterward. Class IIb and III get a full prior review.
- The manufacturer owns the registration, but it needs a Colombia-domiciled legal representative and an importer that holds the required storage and conditioning certificate.
- Build UDI data and vigilance (Resolución 4816 de 2008) into the launch plan, not into year two.
We cover this in more detail in our note on INVIMA market authorization when the device is already FDA-cleared or CE-marked.
What reliance shortens, and what it doesn’t
Reliance compresses one thing: the regulator’s scientific and technical review of a device another authority already reviewed. In our experience, the calendar is just as often set by work that sits outside that review:
- Legalized documents. Certificates of free sale, ISO 13485 certificates and powers of attorney need apostille or consular legalization. Procurement of FDA export certificates has its own queue.
- Translations. Spanish and Portuguese technical files, labels and IFUs must match the approved reference version term for term.
- The in-country holder. No agency in the region will register a device without a local party responsible for it.
- Country-specific certifications. GMP certification and INMETRO in Brazil are separate tracks.
- Post-market duties. Vigilance, field actions and renewals start the day the registration is granted.
When those pieces are prepared in parallel with the reliance file, sponsors see real time savings. When they start after the file is submitted, reliance buys very little.
A checklist before you file
- Which reference approval do we hold, and was it granted through an ordinary review?
- Is the device we will register essentially identical to the one the reference authority approved, including manufacturing site?
- Is the reference approval valid today, and will it stay valid?
- Who is our holder or legal representative in each country, and who owns the registration number?
- Are legalized certificates and translations ordered now, not after the first deficiency letter?
- Have we mapped the post-market obligations that start on approval?
Running several markets at once
Most device companies we work with want Brazil and Mexico in the same year, and often Colombia, Peru or Central America next. The registration files differ, but the source documents are the same. Building one master dossier, one terminology set and one holder structure across markets is where the time savings compound.
The LATAM Launch Subscription is how bioaccess® packages registration and in-country holding across several Latin American markets under one engagement, so you aren’t managing a separate consultant in every country. Learn how it works at bioaccessla.com/market-access.