Colombia INVIMA Regulatory Requirements for Medical Devices and IVDs

Colombia’s Medical Device Market

Colombia’s healthcare system relies on imports to source advanced medical technology. It’s one of the largest medical device markets in Latin America, which makes it an attractive market for medical device importers, particularly those in the US, Europe, and Canada with whom Colombia has Free Trade Agreements. Alignment with registration requirements in other markets and expedited approval for some low-risk devices streamline the device registration process. Here’s an overview of Colombia’s regulatory process for medical devices and IVDs.

Regulatory authority

Medical devices sold or distributed in Colombia are regulated by National Institute of Drug and Food Surveillance (INVIMA). Market authorization from INVIMA is required before devices or IVDs can be imported to Colombia. INVIMA enforces compliance with Decree 4725/2005 for medical devices and Decree 3770/2004 for IVDs, as well as modifying decrees.

Device classification

Medical device and IVD classification references rules in the European Union and the Global Harmonization Task Force (GHTF). Medical devices are classified as I, IIa, IIb, or III based on their risk profile. IVDs are classified into Class I, Class II, and Class III.

Registration process

If your device is Class I or IIb, it is eligible for automatic approval (uncontrolled) under INVIMA. Class IIb and III devices are subject to regulatory review and more comprehensive documentation requirements (controlled). Minimum documentation requirements include market authorization from a recognized reference market (Australia, Canada, Japan, Europe, or the United States) or a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from the country of origin, product information, commercial history, labeling, and a quality management system certificate. Controlled device submissions can also require technical documentation, test reports, and clinical data. Test reports may also be required for Class IIa devices. Registration documentation must be translated to Spanish.

Quality management system (QMS) requirements

INVIMA requires manufacturers to submit proof of a certified quality management system. Most manufacturers leverage an ISO 13485 certificate for this requirement, though other QMS certificates may be accepted depending on your reference market.

In-country representation

Foreign manufacturers need a Legal Representative to represent them to INVIMA. The Legal Representative must have a physical address in Colombia and be a licensed attorney.

Expert Support for INVIMA Registration and Market Entry

Considering INVIMA registration for your medical device or IVD? Our team of experts can help you strategize and coordinate market entry in Colombia. Contact us to learn more about Columbia registration.