Regulations
Last Updated: 06 August 2026
The LATAM market is a good opportunity for medical devices manufacturers, but LATAM Medical Device Registration is much more complicated than it seems at first sight. Indeed, every country has its own independent regulatory system of LATAM Medical Device Registration strategy, and it is vital to understand the peculiarities of each and every LATAM country to enter this market with your products. To start with, one should adjust to the needs of each and every jurisdiction and make documentation translations according to its language and legal peculiarities. Every target country has its regulatory bodies, for instance, ANVISA medical device registration in Brazil, COFEPRIS in Mexico, INVIMA in Colombia, ANMAT in Argentina, and many others. LATAM medical device registration is complicated and requires a proper strategy along with the understanding of subtleties of each country’s legislative acts. Any misstep will cost one a lot both moneywise and in terms of time lost. But with a proper strategy, one will have many advantages.
As we mentioned before, every country has its regulatory requirements and technical specifications. Let us point out that in many cases they are revised to global equivalents. For example, such regulatory acts as RDC 751/2022 and RDC 848/2024 in Brazil, which became valid in October 2024, give requirements to medical devices. It is vital to mention that high risk devices should be certified with BGMP in Brazil. Moreover, Mexico tries to improve the procedure of COFEPRIS medical device registration by introducing the “equivalency” pathway of only 30 days for many FDA and EU cleared devices. From 2026, INVIMA in Colombia will require UDI labeling, while ANMAT medical device registration in Argentina requires an Authorized Agent in addition to the technical review, which may take up to 18 months.
If you are looking to enter the LATAM market, we can assist you in preparing the necessary technical dossier and work with local partners. We handle everything on our end and only report to you, so you can save time and money.
Latam Medical Device Registration Services By Country
Our experts will help you prepare the technical documentation for registration of medical devices in Latin American countries according to their regulatory requirements: Brazil, Chile, Colombia, Mexico, Peru, etc. We provide end to end registration support as well as consultation on local regulations and rules for medical device distribution in your specific market of interest.
Brazil Medical Device Registration
Medical devices should comply with ANVISA medical device registration rules and RDC 751/2022, and a recently issued regulation RDC 848/2024. It should be noted that there is an approval procedure regulated by a 4 tier risk classification (Classes I to IV) depending on the type and invasiveness of the medical device.
Classes I (low risk) and Class II (medium risk) require the notification (Cadastro) procedure. Class I products can be approved automatically electronically while Class II requires 30 to 90 business days and the fee for Classes I and II is from 1,500 to 3,000 BRL. It is worth noting that these classes need some technical documents and compliance with Brazilian labeling regulations.
The most complicated procedure is related to Class III (high risk) and Class IV (very high risk). Such classes need the registration (Registro) procedure, which takes 250 days and government fees of then 49,000 BRL. It is important to provide a technical dossier, clinical data evidence, and the full review by ANVISA medical device registration. In addition, high risk classes require obtaining the certificate of good manufacturing practice (GMP), meaning the verification of exact quality standards of production.
Entering Brazil depends on the classification. The main pitfalls are the incorrect classification of the device and provision of insufficient clinical data leading to delays. Technical files, sterilization validations and other instructions have to be localized and meet the international standards such as ISO 13485. Following such conditions, companies guarantee patients' safety and get efficient access to Brazilian medical device registration to the biggest healthcare market in Latin America.
Mexico Medical Device Registration
Obtaining a Sanitary Registration (Registro Sanitario) is a legal prerequisite for placing medical equipment in circulation in Mexico. COFEPRIS medical device registration (Federal Commission for the Protection against Sanitary Risks) is a supervising authority responsible for the evaluation of such applications.
COFEPRIS (Federal Commission for the Protection against Sanitary Risks) acts as Mexico's leading health authority in charge of all activities similar to FDA in the USA. Being a kind of 'gatekeeper' to Mexico, it regulates medical devices from their classification according to risk and facility to post market safety issues. Starting 2025, this organization greatly modernized its approach to regulation, aligning itself with international principles such as IMDRF and MDSAP. It is reflected in the launch of the so called "equivalency" pathway which enables manufacturers with FDA or EU approvals to skip preparation of technical dossier in favor of the 30 day expedited review. In case of the riskiest devices, such as Class III it takes even 60 business days. As far as Class III is concerned, COFEPRIS medical device registration takes up to 60 business days.
Cost for a new Mexico Medical Device Registration depends on device classification in terms of risks. Government fees for the application for registration are $16,499 MXN for Class I (Low Risk), $24,198 MXN for Class II, and $30,798 MXN for Class III. If you apply for renewal of an existing registration, then you pay 75% of the initial fee, which gives the following values: $12,374 MXN for Class I, $18,149 MXN for Class II, and $23,098 MXN for Class III. Please keep in mind that the values stated above are in Mexican Pesos.
Under the 3 tier risk classification system, COFEPRIS requires foreign manufacturers to designate Mexico Registration Holder (MRH), as well as comply with Spanish labeling and quality management standards (NOM-241). New 2026 regulations have simplified the situation by introducing renewal of registrations for 10 years and reducing time needed for renewing registrations for low risk devices. International companies find it most efficient to comply with such requirements within a more comprehensive business strategy, usually using partnerships with local manufacturing facilities for handling the infrastructure and retaining control over technical regulatory aspects of the process.
Colombia Medical Device Registration
The procedure of medical devices registration in Colombia is performed by the National Food and Drug Surveillance Institute (INVIMA). In accordance with Decree 4725 of 2005, all medical devices shall be registered at INVIMA prior to their importation and release for distribution/sale in Colombia. Medical devices are divided into four classes of risk as follows: Class I (Low risk), Class IIa (Moderate risk), Class IIb (High risk), and Class III (Very High risk). In order to register their products on Colombian territory, foreign medical device manufacturers need to authorize their legal representative or importer in Colombia who will be the applicant of the device registration.
The Colombia Medical Device Registration approval time mainly depends on the risk class of the product. As per the requirements of INVIMA, Class I and IIa devices are processed through the "automatic" procedure, the certificate is issued to the applicant after the evaluation of application. On the contrary, medical devices of Class IIb and III require "technical scientific evaluation" and more detailed review. It should be noted that the approval time of Class I and IIa medical devices is 2-4 days, while for Class IIb and III the approval takes 4-6 months. The cost of the procedure varies from USD 750 (Class I and IIa) to USD 850 (Class IIb and III). Furthermore, applicants have to expect to submit the Certificate of Free Sales in a chosen jurisdiction, ISO 13485 certificate, and technical specification sheets translated into Spanish.
Finally, starting from 2026, Unique Device Identification (UDI) standards have become obligatory for medical devices registration in Colombia. After approval, the registration will be valid for 10 years, however, the holder has to perform "Technovigilance" in order to notify INVIMA about the incidents or field safety corrections.
Argentina Medical Device Registration
In order to sell medical devices in Argentina, any company should follow the regulations set by the National Administration of Drugs, Foods, and Medical Technology (ANMAT). According to the Mercosur classification, medical devices are divided into four categories (I-IV) depending on the risk level. Additionally, any medical device manufacturer should be able to prove that their production meets ISO 13485:2016 and Good Manufacturing Practices requirements;
One of the essential steps in ANMAT medical device registration is appointing an Argentine local agent (AAR). They are the exclusive registration holder and the ANMAT medical device registration liaison. In most cases, it is not possible to cancel an AAR, and if it is possible, the ANMAT registration should be re applied for;
For the registration of Class II, III, and IV medical devices, the AAR should submit a registration request followed by a technical assessment. A site inspection is required for Class III and IV medical devices since they represent higher levels of risk. Even though legal evaluation takes 180 days, ANMAT medical device registration procedures may take up to one and a half years. A registration certificate is valid for five years, but the renewal should be applied for 90 days before the expiration date. Moreover, all technical files, labeling, and instruction for use should be provided in Spanish. Any significant changes to a device design or manufacturing process should be submitted for ANMAT approval before applying for registration.
Costa Rica Medical Device Registration
Medical device registration in Costa Rica is regulated by the legislation issued by the Ministerio de Salud (Ministry of Health). In local terminology, the products under consideration are referred to as Biomedical Equipment and Materials (EMB). LATAM Medical Device Registration is defined by the 4 tier risk classification scheme which is quite similar to the one used in Health Canada.
The devices of class 1 are exempted from registration procedures. Class 2 is characterized by the simplified procedure. Devices of Class 3 and 4 (the highest risk) should have very precise documentation that will include the information on clinical trials and the post marketing surveillance plan. It should be noted that the registration process is accelerated in case when the device of high risk category has already been cleared for sale in the USA.
Applicants are expected to submit the notarized Free Sale Certificate proving that the device is legally sold somewhere else. Also, the applicant should supply the technical specifications of the product, information on sterilization and instruction manual which should be translated into Spanish.
The application is reviewed in two stages: the legal review (phase 1) and technical review (phase 2). After approval by the Ministry, the company receives a certificate of registration which is valid for 5 years. Any mistake in the procedure of registration may lead to the denial of the registration of the device.
Costa Rica medical device registration can take up to 6 to 8 months but the process can be accelerated in case when the device is already approved in the United States.
Puerto Rico Medical Device Registration
Puerto Rico is a U.S. territory, LATAM medical device registration is federal law enforced through a two tier system, which requires that all medical devices first satisfy the U.S. Food and Drug Administration (FDA) requirements, including the 510 (k), a PMA, or an exemption, and a formal establishment registration and product listing at the federal level. In parallel, on the local level, the Puerto Rico Department of Health (PRDoH) is responsible for the distribution of medical devices, meaning that firms need to obtain local permits and licenses to sell or store medical devices in the territory. While English is the official language of Puerto Rico, it is standard practice – and often a local requirement – to also provide labeling and instructions for use in Spanish to satisfy the local market needs.
The FDA establishment registration fee is $11,423, a mandatory annual cost for most facilities that is not eligible for small business discounts. For product clearance, a standard 510(k) submission costs $USD while a high risk PMA could be $579,272; however, businesses certified under the Small Business Determination (SBD) program pay significantly reduced rates, such as $ USD for a 510 (k).
The FDA’s standard time for review is 90 days for 510 (k) and 180 days for a PMA, but the overall process is often closer to 6 or more months due to the additional time needed for administrative processing and possible “requests for additional information.” At the local level, Puerto Rico’s licensing process takes several months, and additional administrative fees (usually ranging from a few hundreds to a few thousands of dollars) are due to secure the local “botiquín” distributor’s license.
Strategic Market Access Latam Medical Device Registration Support
One of the most significant commercial risks when registering medical devices in LATAM is the potential loss of control of your intellectual property. Since regulatory affairs in LATAM (ANVISA, COFEPRIS, and INVIMA) require a local entity to hold a product’s registration on its premises, many companies appoint their commercial agent who, in fact, manages their registrations on their behalf. However, this option grants the agent full authority and responsibility regarding the product’s presence on the market. As a consequence, any changes to the appointment or termination of the contract may lead to complex and time consuming legal proceedings and, in some cases, the need to reapply for regulatory approvals.
Morulaa Health Tech understands the nuance of the local regulatory affairs landscape, and our team can help you navigate through the intricacies of choosing the right commercial and legal strategy while protecting your rights as the original product developer. Although we do not hold any licenses ourselves, we can advise on preparing your dossier in detail, and both your local entity and our team will work together to achieve it. We take on the responsibility of preparing your Declaration of Conformity, ISO 13485 and MDSAP certificates, and other documents while handling the complex task of localization and translation for ANVISA medical device registration in Brazil, ANMAT medical device registration in Argentina, and other jurisdictions.
Besides, we can help you update your regulatory strategies to prepare your devices for 2026 entry into the Latin American market with its unique identification (UDI) and surveillance requirements, including new safety standards for Colombia. Ultimately, our team’s primary goal is to assist you as the competent authority ensuring the safe and scalable long term development of your product in LATAM.
FAQS
How does the new ANVISA medical device registration work in 2026?
Under RDC 751/2022 and RDC 848/2024, Brazil medical device registration now utilizes a risk based categorization where Class I and II products can get expedited “notification” while higher risk Class III and IV medical devices require full ANVISA medical device registration, which may necessitate valid Brazil GMP or MDSAP certification
I want to know if I can expedite my Mexico medical device registration using the 2026 Reliance Model ?
Yes, you can leverage the updated COFEPRIS reliance framework to do so. The new COFEPRIS reliance framework allows for a faster alternative route for registering medical devices in Mexico, which can be completed within 30 business days so long as the device in question is identical to an FDA or Health Canada certified medical device.
What are the latest requirements for Colombia medical device registration?
Starting in February 2026, medical device registration in Colombia now requires “Semantic Standard Reporting” to improve traceability across the market. This means that licensees must report UDI DI codes via a dedicated portal as a prerequisite to commercialization, as non reporting medical devices will be prohibited from being placed on the market.
How do I register an ANMAT medical device in Argentina today?
ANMAT medical device registration requires applications to be submitted via the HELENA electronic portal by an agent located in Argentina. In general, Class I and II medical devices utilize a “Declaration of Conformity” procedure while Class III and IV medical devices require a technical review of the CSD. In all cases, ANMAT approvals are valid for 5 years.
What language/labeling rules must I follow for these LATAM markets?
Language requirements are generally strict in LATAM, meaning that technical files and labels must be in Portuguese for Brazil, and Spanish for Mexico, Colombia, and Argentina. Aside from general language requirements, additional regional specific regulations such as Argentina’s Disposición 64/2025 must also be followed when preparing technical dossiers for any of these jurisdictions.