Colombia is a rapidly growing Latin American market with increasing healthcare investments and strong demand for innovative pharmaceuticals, medical devices, and health products.
The National Institute of Drug and Food Surveillance (INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is the national regulatory authority responsible for the registration, importation, distribution, quality control, pharmacovigilance, and post-market surveillance of medicines, medical devices, cosmetics, and biologics in Colombia. INVIMA requires product registration, import permits, GMP compliance, quality certificates (CPP, GMP), Spanish labelling, and local sanitary registration holder representation. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate INVIMA requirements, prepare compliant dossiers, secure timely approvals, and achieve efficient market entry and sustained compliance in this dynamic Latin American market.
Get Colombia Compliance Support
Preparation of regulatory dossiers (CTD format), supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for INVIMA submissions.
End-to-end support for INVIMA registration of medicines, medical devices, biologics, and health products in Colombia.
Assistance with INVIMA import/export authorizations, sanitary import permits, batch release certificates, and customs documentation.
Guidance on INVIMA GMP requirements, quality assurance documentation, certificate support, and preparation for inspections.
Setup of pharmacovigilance systems, adverse event reporting to INVIMA, periodic safety reporting, and risk management in Colombia.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with INVIMA post-registration requirements.
Spanish labelling review, INVIMA-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local sanitary registration holder/agent requirements, INVIMA liaison, regulatory follow-up, and ongoing compliance management in Colombia.
Strategic market entry planning, INVIMA pathway guidance, regulatory intelligence on Colombia’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Colombia — from INVIMA product registration and import permits to pharmacovigilance, Spanish labelling, and sustained Latin American market access.
Contact Our Colombia Regulatory Experts