INVIMA Colombia Medical Device Registration
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.
Understanding Medical Device Classifications and Regulatory Requirements in Colombia
Regulatory Authority
Pure Global can assist with Colombia medical device registration, ensuring INVIMA approval to sell in the Colombian market.
Classification
- Medical Devices: Classified into Classes I, IIa, IIb, and III based on risk, following 18 specific rules. The classification determines the registration process, with low-risk devices granted automatic registration and high-risk devices requiring a thorough review by INVIMA.
- IVDs: Classified into Classes I, II, and III based on risk, with the classification process guided by 4 specific rules. The registration renewal period varies, with a 10-year renewal for Classes I and II and a 5-year renewal for Class III.
Key Requirements
To market in Colombia, foreign manufacturers must:
- Appoint a legal representative in Colombia for registration submission to INVIMA.
- Work with a CCAA certified importer for medical device importation.
- Understand the classification to navigate the registration process effectively, with renewals every 10 years for medical devices and varying for IVDs based on class.
Tailored Support for Market Entry
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.
Frequently
Asked Questions
Why is INVIMA registration important for international medical device companies in Colombia?
Colombia, being the third-largest medical device market in Latin America, presents significant opportunities for international companies. Over 80% of its medical devices and IVDs are supplied by foreign manufacturers, making Colombia medical device registration with INVIMA crucial for market entry and expansion.
How are medical devices classified in Colombia under INVIMA regulations?
Medical devices in Colombia are classified into Classes I, IIa, IIb, and III based on risk, following 18 specific rules under Colombia medical device regulations. Low-risk devices are granted automatic registration, while high-risk devices require a thorough review by INVIMA.
What are the key requirements for registering a medical device in Colombia?
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.
What is the renewal period for registered medical devices and IVDs in Colombia?
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.
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