INVIMA Colombia Medical Device Regulations
Medical devices and IVDs sold in Colombia must first obtain regulatory approval from INVIMA.
Key medical device and IVD regulations in Colombia
Medical devices in Colombia are regulated by the National Food and Drug Surveillance Institute (INVIMA). INVIMA oversees the regulation of medical devices and IVDs, as well as foods, drugs, pharmaceutical, and biological products. Before you can legally distribute your medical device or IVD in Colombia, you must submit a health registration application to INVIMA for approval.
INVIMA enforces requirements in the two primary health regulations:
- Decree 4725/2005 outlines the regulatory framework for medical devices.
- Decree 3770/2004 outlines the regulatory framework for IVDs.
INVIMA medical device classification is nearly identical to the classification scheme for medical devices in Europe under the EU Medical Devices Regulation (MDR). Medical devices are classified into four levels according to their risk profile: Class I, Class IIa, Class IIb, Class III.
INVIMA Colombia medical device regulatory process
There are two registration pathways for medical devices in Colombia: uncontrolled and controlled. Uncontrolled devices, which includes Classes I and IIa, are eligible for automatic approval from INVIMA following submission of a complete registration application. Class IIb and III devices are controlled, and INVIMA will conduct a review of your registration documentation before approval.
Detailed technical documentation, including design and manufacturing information, clinical data, risk assessments, and labeling documentation, must be submitted as part of the registration dossier to demonstrate compliance. Here is a high-level overview of INVIMA's documentation requirements:
- Legal Representative located in Colombia (for foreign device companies)
- Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from the country of origin or acceptable reference market (Australia, Canada, Japan, Europe, or the United States)
- Proof of quality management system, such as an ISO 13485 certificate
- Technical documentation, clinical data, test reports, etc. as appropriate for your device classification.
Your registration materials must be submitted in Spanish.
Helpful resources for COFEPRIS medical device registration
As you begin planning to market your device in Colombia, here are some resources that will be useful along the way:
- INVIMA: Colombia’s medical device and IVD regulatory authority.
- Decree 4725/2005: Colombia’s medical device regulatory framework.
- Decree 3770/2004: Colombia’s IVD regulatory framework.
Frequently
Asked Questions
What if I don’t have home country approval?
Home country approval is generally required for approval in Colombia. However, INVIMA will also accept a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from Australia, Canada, Japan, Europe, or the United States in place of home country approval.
Is an ISO 13485 certification required for INVIMA medical device approval?
Not necessarily. Many manufacturers submit ISO 13485 certificates to satisfy the QMS requirement under INVIMA. However, other forms of QMS certification are also accepted.
What is the role of a medical device importer in Colombia?
The importer purchases products to ship them into Colombia. Your importer must appear on your health registration. Also, you must begin importing devices within three years of your regulatory approval or INVIMA can cancel your registration.
