Navigating the Intricate Regulatory Landscape of Colombia's Medical Device Market

Entering the Colombian medical device and IVD market offers significant opportunities for MedTech companies aiming to expand across Latin America. However, success hinges on understanding and complying with Colombia’s rigorous regulatory requirements, centered around the vital process of sanitary registration (Registro Sanitario).

The Foundation: Understanding the Sanitary Registration

At the core of Colombia’s medical device regulation is the sanitary registration, an approval granted by INVIMA — the National Food and Drug Surveillance Institute. This registration acts as a legal testament that a device meets Colombia’s strict standards for safety, efficacy, and quality. It’s more than just a license to sell; it’s a comprehensive endorsement that your product complies with local health regulations.

The Dynamic Lifecycle of a Product: Changes in Ownership and the Need for Transfer

The lifecycle of a medical device or IVD product isn’t static. Companies often undergo mergers, acquisitions, strategic partnerships, or restructuring of distribution networks. When ownership of a registered device changes hands, a simple paperwork update isn’t enough. Instead, a formal and legally binding process known as the transfer of sanitary registration (cesión de la titularidad del registro sanitario) must be meticulously executed.

Failing to properly manage this transfer can lead to serious repercussions — from market access delays and lost sales to legal penalties and financial liabilities. Therefore, understanding and executing this process correctly is crucial for ongoing market presence.

The Transfer Process: A Multi-Faceted Procedure

Executing a transfer of sanitary registration involves several critical steps, demanding a deep understanding of Colombian regulatory law and INVIMA’s specific protocols.

1. Formalizing the Transfer Agreement

The initial step is to formalize the transfer of ownership between the current holder (the cedent) and the new holder (the assignee). This is typically done through a rights transfer agreement or a formal letter of authorization, explicitly stating the intent to transfer the registration associated with its unique number. This document is the cornerstone of the application and must be clear and unambiguous.

2. Addressing the Legal Domicile of the New Holder

The procedural requirements differ based on the domicile of the new owner:

• Foreign company without a Colombian subsidiary: INVIMA mandates appointing a local legal representative in Colombia to manage the transfer process.
• Colombian-based company: They can often manage the submission directly, provided they have the properly legalized rights transfer letter.

3. Preparing the Documentation

This phase demands meticulous attention to detail. Key documents include:

• The application form submitted to INVIMA.
• The original or notarized and apostilled copy of the rights transfer agreement.
• The Certificate of Legal Existence and Representation of the new holder, issued by the Chamber of Commerce.
• Proof of compliance with post-market obligations, such as a certified storage or handling facility (CCAA), if applicable.
• All foreign-language documents must be translated into Spanish by certified translators.

4. Submission and Review

Once assembled, the dossier is submitted to INVIMA for review. The process involves a thorough legal and administrative evaluation, verifying compliance with regulations such as Decree 4725 of 2005.

Any inconsistencies or missing information may trigger an auto (request for additional information). Timely and precise responses are essential; failure to do so can result in rejection, requiring restarting the process, which incurs delays and additional costs.

5. Final Recognition and Legal Transfer

Upon approval, INVIMA issues a resolución — an official resolution recognizing the new owner as the legal holder of the sanitary registration. This document completes the transfer, transferring all legal responsibilities, including post-market surveillance, vigilance, labeling, and promotional updates.

Challenges in the Transfer Journey

This process is fraught with potential hurdles: navigating language barriers, managing complex legal documentation across jurisdictions, and understanding INVIMA’s nuanced review procedures. Mistakes can be costly, leading to delays and regulatory issues.

How Pure Global Simplifies Market Access

This is where Pure Global becomes an invaluable partner. With a strong presence in Colombia and over 30 markets worldwide, Pure Global specializes in transforming complex regulatory challenges into streamlined strategies.

End-to-End Support

• Local Representation: They facilitate appointment of trusted local representatives, fulfilling INVIMA requirements without establishing a local subsidiary.
• Regulatory Strategy: Their teams develop efficient pathways, ensuring all documentation — transfer agreements, legal certificates, translations — is meticulously prepared to prevent rejections.
• Use of Advanced Tools: Leveraging AI and data analytics, they optimize dossier compilation, manage submissions, and monitor regulatory updates proactively.

Tailored Solutions for All Company Sizes

Whether startups, scaleups, or multinational corporations, Pure Global offers a comprehensive, integrated approach to navigate the legal and regulatory landscape in Colombia and beyond.

Start Your Market Access Journey Today

Navigating Colombia’s medical device regulatory environment and executing sanitary registration transfers can seem daunting. However, with the right expertise and strategic support, it becomes a manageable, even strategic, step toward expanding your market footprint.

For seamless access and expert guidance, contact Pure Global at info@pureglobal.com or visit pureglobal.com. Let us help you turn regulatory challenges into growth opportunities in Colombia and across Latin America.