Medical Device Registration Costs and Timelines for Brazil, Mexico, and Colombia

Entering new international markets is a critical growth strategy for medical device and IVD companies, but it comes with a price tag. From government fees and required translations to consulting, ongoing representation, and post-market expenses, it’s important to consider the bigger picture. Accurately estimating how much it will cost and how long it will take can help you align your global strategy with your budget and business objectives.  

This guide provides a detailed look at cost and timelines in the three largest Latin American markets - Brazil, Mexico, and Colombia - so you can avoid potentially overpaying for services and plan a successful market entry project.

Medical device and IVD registration costs and timelines in Brazil

Brazil is the largest country in Latin America with a population of more than 210 million. Only 31% of the medical devices registered in Brazil are manufactured locally. The rest come mainly from China, the USA, and Europe. Brazil's medical device regulator is The National Health Surveillance Agency, also known as ANVISA (Agência Nacional de Vigilância Sanitária). Foreign manufacturers must appoint an in-country representative (license holder) to manage the registration process and communicate with ANVISA.  

The new procurement law has expanded access for international companies to participate in public tenders. However, the product must be registered in Brazil through an in-country representative.

Costs

Registration costs are primarily influenced by device class and BGMP (Brazilian GMP) certification status. For Class I/II notifications, when using an in-country representative, the cost to compile and submit to ANVISA ranges from $1,000 to $2,000 (government fees and translation costs included) per notification depending on the number of notifications. The average cost per notification typically decreases if you are notifying multiple devices.

For Class III/IV registrations, the submission and approval process is more complicated. The total cost to compile and submit to ANVISA ranges from $4,000 to $6,000 per registration for most products (including government fees and translation costs). In addition, a $13,500 (BRL 72.804,90) ANVISA fee must be paid for BGMP certification per manufacturer.  

When registering an electrical device, INMETRO testing and certification is required (estimated cost $4,000 to $6,000) and for devices that use wireless technologies, ANATEL certification may apply (estimated cost $3,000 to $4,000).

Your in-country representative can outline the ANVISA registration requirements and the BGMP certification process, as well as help select local INMETRO and/or ANATEL certifiers, if needed.

After obtaining ANVISA approval, ongoing costs payable to the in-country representative include an annual fee, generating letters of importation for distributors, processing modifications, and post-market surveillance (PMS) and vigilance follow up. For Class I/II products, a budget of $1,000 to 2,000 per year per product should be sufficient to cover these activities, with the exception of large-scale vigilance activities. For Class III/IV products, $1,500 to $3,000 per year per product should be budgeted for.

Ongoing renewal and maintenance costs need to be paid to INMETRO or ANATEL certifiers when applicable (estimated at $1,000 per certificate). For Class III/IV devices, the ANVISA BGMP fee of $13,500 needs to be paid every 2 or 4 years (see in the Timelines section below).

Timelines

When all requirements are met, Class I/II device dossiers can be compiled and submitted within one week, with approval by ANVISA expected in 30 days. Class I/II notifications do not require renewals. The compilation and submission of a Class III/IV dossier can be done in two weeks, with ANVISA review and approval usually within 6-12 months, depending on the device type.

The BGMP certification from ANVISA can be obtained within two months when leveraging a Medical Device Single Audit Program (MDSAP) certificate, and within six months when leveraging the ABIMED injunction through your in-country representative. A Class III/IV device registration requires a renewal every ten years. BGMP certification is valid for two years, extended to four years when leveraging MDSAP.

Medical device and IVD registration costs and timelines in Mexico

Mexico is the second largest country in Latin America with a population of more than 130 million. It imports more than 80% of medical devices and IVDs for domestic use. The Federal Committee for Protection from Sanitary Risks (COFEPRIS) regulates and authorizes market access for medical devices in Mexico.  

COFEPRIS recently announced a new Abbreviated Regulatory (Equivalence) Pathway effective September 1, 2025. It allows manufacturers to leverage prior authorizations from the US FDA, EMA (CE Marking under MDR, IVDR, MDD, or IVDD), Health Canada, Swissmedic, ANVISA, TGA, MFDS, and NMPA, as well as other ICH, WHO, IMDRF, and MDSAP-recognized bodies. The new equivalence pathway is intended to dramatically reduce the length of COFEPRIS evaluations.

Foreign manufacturers must appoint an in-country representative (license holder) to submit applications and coordinate communication with COFEPRIS.

Costs

When using an in-country representative, the cost to compile and submit a dossier to COFEPRIS, with government fees and translation costs included, typically ranges from $1,000 to 2,000 for LR (Low Risk) devices, $3,000 to $4,000 for Class I devices, and between $5,000 and $7,000 per registration for Class II/III devices, depending on the number of registrations. Your cost per registration typically decreases when you register multiple devices. COFEPRIS registrations are valid for 5 years.

After obtaining COFEPRIS approval, ongoing costs include an annual fee to the in-country representative, processing modifications, and post-market surveillance (PMS) and vigilance follow up. A budget of $5,000 per year should be sufficient to cover these activities, with the exception of large-scale vigilance activities and when processing a high number of modifications. Registration renewal cost should not exceed more than 50% of the original registration cost.

Timelines

When all dossier requirements are met, a submission to COFEPRIS can be completed within a month. Under the new Abbreviated Regulatory Pathway (equivalence route), COFEPRIS has set a target review time of 30 working days. While this is a target review time, it may not be achievable in every case.  

Medical device and IVD registration costs and timelines in Colombia

As the third largest country in Latin America, Colombia has a population of more than 50 million and imports more than 80% of medical devices and IVDs used domestically. Medical devices and IVDs are regulated by the National Food and Drug Surveillance Institute (INVIMA).

There are two registration pathways for medical devices in Colombia: uncontrolled and controlled. Uncontrolled devices, which include Classes I and IIa, are eligible for automatic approval from INVIMA following submission of a registration application. Class IIb and III devices are controlled, and INVIMA conducts a review of your registration documentation before granting approval.

Foreign manufacturers are required to appoint a local in-country representative and must identify an importer with CCAA - Certificado de Capacidad de Almacenamiento y Acondicioanamiento (Certificate of Storage and Conditioning Capacity) – before they can register devices with INVIMA. The in-country representative may be able to help meet the CCAA requirement as well.

Colombia’s Resolution 1405 of 2022 introduced mandatory UDI-DI requirements and a semantic reporting process for medical devices and IVDs, requiring registration holders to submit detailed product information via INVIMA’s web platform. To complete the process, registration holders must provide UDI-DI codes from certified agencies, secure INVIMA approval, submit the semantic report, and pay a fee.

Costs

The overall cost of INVIMA device registration when working through an in-country representative is usually between $2,000 and $3,000 per registration, including government fees and translation costs, depending on the device class and how many products are being submitted. The per-device cost can decrease if you file multiple registrations at once.  

Following INVIMA approval, companies should budget for recurring expenses, such as annual payments to the in-country representative, fees for amendments or modifications, post-market surveillance and vigilance activities, and in some cases an annual CCAA charge if not managed by the importer. A budget of $5,000 annually is generally adequate to cover these activities, except for extensive vigilance requirements or frequent modifications. Renewal fees are usually no more than 50% of the original registration cost.

Timelines

Class I and IIa devices can be prepared and filed in about 3–4 weeks, with INVIMA granting automatic approval once the dossier has been submitted. For Class IIb and III devices, the same preparation period applies, but regulatory review by INVIMA typically takes 6–8 months. Registrations are valid for 10 years, except for Class III IVDs, which must be renewed every 5 years.

How Your Local Representative Affects Costs and Timelines

Choosing the right in-country representative is one of the most important decisions you will make in a registration project. A knowledgeable and responsive in-country representative not only helps ensure compliance but also reduces the risk of delays and unnecessary expenses. When evaluating in-country representatives, consider how post-approval services and fees are structured in their contracts, as these can significantly affect long-term costs. With offices in Brazil, Mexico, and Colombia, Pure Global can be your experienced local representative in major Latin American markets. We'll help you bring devices to market quickly and efficiently.

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