INVIMA Colombia Medical Device Regulations

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.

Colombian classification shares risk-based concepts with other systems but must be determined from its own current rules. 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

Ordinary Class I/IIa devices generally use automatic registration and ordinary IIb/III devices the applicable evaluation route. Controlled-technology biomedical equipment is assessed separately under its marketing-permission provisions.

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.

Semantic reporting and identifiers in Colombia

Resolution 1405/2022 establishes a semantic and coding framework for covered devices and IVDs. Confirm the current scope, implementation milestones, identifiers, responsible holder and submission instructions. Maintain the applicable records and reconcile the reported regulatory/commercial attributes with the authorization.

Helpful resources for INVIMA 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.

Regulatory map and semantic-data controls

Use INVIMA’s Resolution 1405/2022 entry and current implementation instructions to verify responsible parties, identifiers and records. Do not assume that every foreign issuing agency, platform step or fee applies to every product. Reconcile semantic data with the registration and labeling file.