Regulatory Registration of Titus Medical Devices in Mexico and Colombia

Regulatory Registration of Titus Medical Devices in Mexico and Colombia
A turnkey market access solution for Titus Medical's expansion into key Latin American markets. Our comprehensive approach ensures regulatory clearance for Class IIA catheters with both COFEPRIS (Mexico) and INVIMA (Colombia).
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bioaccess®, July 28, 2025 
Executive Summary
Strategic Expansion
This proposal supports Titus Medical's objective to expand its international footprint into the key Latin American markets of Mexico and Colombia, requiring a strategic partner to navigate complex regulatory landscapes.
Two-Speed Market Entry
Our approach leverages Colombia's unique "Automatic Registration" pathway for near-immediate market access, while concurrently pursuing rapid registration in Mexico via the "Equivalency Route" made possible by existing FDA approval.
Complete Control
Our end-to-end management includes mandatory in-country representation, ensuring Titus Medical retains absolute control over its regulatory assets and commercial destiny with transparent, bundled pricing.
Mexican Regulatory Landscape (COFEPRIS)
The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) governs medical devices in Mexico. All devices require pre-market approval before legal marketing and sales. The regulatory framework is defined by the General Health Law and the Regulations of Health Supplies.
Mexico employs a three-tier risk-based classification system: Class I (low risk), Class II (moderate risk), and Class III (high risk). Titus Medical's HSG and SIS catheters are classified as Class II devices based on their nature as sterile, invasive devices for short-term diagnostic use.
Manufacturers must demonstrate compliance with Good Manufacturing Practices (GMP), typically satisfied by providing an ISO 13485 certificate, which aligns with Mexico's standard, NOM-241-SSA1-2021.
Optimal Registration Strategy for Mexico
Equivalency Route
Most strategic pathway for Titus Medical, available to devices with existing approval from recognized international regulatory bodies like the U.S. FDA.
Key Advantages
Reduced timeline, simplified dossier requirements, and cost-effectiveness compared to Standard or Third-Party Review routes.
Documentation
Leverages existing materials with professional Spanish translation of user-facing materials and legal documents.
The projected timeline is 3–6 months from submission to final issuance of the registration certificate, based on current real-world performance of the agency for the Equivalency Route.
In-Country Representation in Mexico
A critical legal requirement for any foreign manufacturer entering the Mexican market is appointing a Mexican Registration Holder (MRH). The MRH is a Mexican legal entity that submits the registration application and becomes the legal owner of the resulting certificate.
While appointing a local distributor as MRH may seem convenient, this introduces significant commercial risk. If the relationship terminates, the distributor retains full ownership and control of Titus Medical's market access.
Our annual MRH service is a strategic investment in commercial sovereignty. By appointing our firm—an independent regulatory specialist—Titus Medical retains 100% ownership and control of its regulatory assets, with complete flexibility to appoint, change, or add multiple distributors at any time.
Colombian Regulatory Landscape (INVIMA)
Colombia's medical device market is regulated by the National Institute of Drug and Food Surveillance (INVIMA), recognized by the Pan American Health Organization. The regulatory framework is primarily established by Decree 4725 of 2005.
The Colombian classification system aligns with the European Union's model, using a four-tier approach: Class I, Class IIa, Class IIb, and Class III. Titus Medical's catheters are classified as Class IIa, unlocking Colombia's most advantageous regulatory pathway.
The Colombian device classification system is closely harmonized with the European Union's model, utilizing a four-tier, risk-based approach that determines the specific regulatory requirements.
Expedited Registration Strategy for Colombia
1
Automatic Registration
INVIMA has implemented an "automatic registration" process for Class I and Class IIa devices. Upon submission of a complete dossier, INVIMA issues the formal registration certificate within approximately 15 working days.
2
Immediate Market Access
This allows the manufacturer to begin importation, marketing, and sales activities right away, while the full technical review is conducted after the registration certificate has been granted.
3
Two-Speed Strategy
While the Mexican registration is underway, Titus Medical can already be active in the Colombian market, generating revenue and establishing a commercial foothold.
All documents submitted to INVIMA must be professionally translated into Spanish, a service covered by the one-time translation fee in this proposal.
In-Country Representation in Colombia
The regulatory framework in Colombia requires foreign manufacturers to appoint a Legal Representative and a licensed Importer of Record (IOR). The Legal Representative must be a local entity in Colombia who manages all interactions with INVIMA.
An INVIMA registration is valid for ten years, making it a significant long-term corporate asset. Appointing a commercial distributor to control the registration creates substantial risk, potentially preventing changes for the full ten-year term.
Our annual service ensures that the INVIMA registration is held exclusively in the name of Titus Medical, providing complete control and commercial agility throughout the entire registration period.
Financial Investment
$15,250
One-Time Investment
Includes professional fees, government fees for both countries, and technical document translation.
$10,000
Annual Services
Mandatory in-country representation services for both Mexico and Colombia (Year 1).
25%
Multi-Country Discount
Applied to both professional fees and annual representation services for this bundled project.
$20,250
Total Initial Investment
After applying the multi-country project discount.
Payment terms are structured to align with key project milestones, with an upfront payment of $16,425 and final milestone payments upon successful delivery of registration certificates.
Future Market Access Support
Market Analysis
In-depth research into market dynamics for OB/GYN diagnostic products, including competitive landscape, pricing structures, and procurement processes.
Distributor Search
Leveraging extensive local networks to identify, screen, and vet potential commercial distribution partners with established relationships in target clinical areas.
Stakeholder Engagement
Facilitating targeted engagement with Key Opinion Leaders, government bodies, payers, and patient advocacy groups to build clinical advocacy and drive adoption.
Our vision is to support Titus Medical through the entire market lifecycle, providing not only regulatory compliance but also the strategic support necessary for sustained commercial success across Latin America.