As the third-largest medical device market in Latin America, Colombia, with a population exceeding 50 million, presents a significant opportunity for international medical device companies.
Over 80% of its medical devices and IVDs are supplied by foreign manufacturers, underscoring the importance of INVIMA Colombia Medical Device Registration for those looking to expand their footprint in this key market.
Colombia's aging population is growing at 3.5% annually, outpacing total population growth (1.7%). By 2050, 27.5% will be 60+. This shift drives a rise in noncommunicable diseases.
Colombia's medical device regulator is the National Institute of Drug and Food Surveillance (INVIMA). Pure Global can assist with Colombia medical device registration and act as your in-country representative, ensuring INVIMA approval to sell in the Colombian market.
To market in Colombia, foreign manufacturers must:
Our comprehensive services are designed to facilitate your market entry into Colombia:
Classification and grouping of your products to identify the regulatory pathway.
Preparation and compilation of the technical dossier for INVIMA registration.
Acting as your local representative for the INVIMA submission, assisting with the CCAA certified importer requirement, and ensuring compliance with post-market regulations.
The cost of INVIMA registration through an in-country representative is usually between $2,000 and $3,000 per device, which includes government fees and translation costs. Costs can decrease when multiple registrations are filed at once. Companies should also budget around $5,000 per year for ongoing expenses such as representation fees, modifications, post-market surveillance, vigilance, and in some cases an annual CCAA charge. Renewal fees are generally no more than 50% of the original registration cost.
Timelines vary based on device classification. For Class I and IIa devices, dossiers can be prepared and filed in about 3–4 weeks, with automatic approval from INVIMA upon submission. For Class IIb and III devices, the same preparation time applies, but INVIMA’s review and approval process typically takes 6–8 months. Once granted, registrations are valid for 10 years, except for Class III IVDs, which must be renewed every 5 years.
To achieve INVIMA Colombia registration, foreign manufacturers must appoint a legal representative in Colombia for registration submission to INVIMA and work with a CCAA certified importer for medical device importation. Understanding the device classification is essential for navigating the registration process effectively.
The registration renewal period for medical devices and IVDs in Colombia varies: Classes I and II medical devices have a 10-year renewal period, while Class III IVDs have a 5-year renewal period under INVIMA registration guidelines.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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