Colombia

In Colombia, the primary regulatory authority for health products is INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), operating under the oversight of the Ministry of Health and Social Protection (Ministerio de Salud y Proteccion Social). The principal legal framework is established by Decree 677 of 1995 for pharmaceuticals, Decree 4725 of 2005 for medical devices and diagnostics, and Resolution 1619 of 2015 for in-vitro diagnostics, among other complementary resolutions. All health products intended for commercialization in Colombia must obtain a Sanitary Registration (Registro Sanitario) or, for certain lower-risk categories, a Sanitary Notification (Notificacion Sanitaria Obligatoria, NSO) before market entry. INVIMA classifies products by risk level, which determines the depth of technical review required and the applicable pathway, ranging from expedited notifications for Class I low-risk devices to full dossier evaluations for high-risk pharmaceuticals and Class III medical devices.

Applicants must appoint a local legal representative or importer established in Colombia, who assumes regulatory and post-market surveillance responsibility before INVIMA. Dossier submissions generally align with Common Technical Document (CTD) formatting for pharmaceuticals, while medical device submissions follow IMDRF-aligned technical documentation principles. Colombia is a member of IMDRF and PAHO, and INVIMA has implemented expedited review pathways for products already approved by stringent regulatory authorities (SRAs) recognized under its Reference Country framework, including the U.S. FDA, EMA, Health Canada, and others designated via Resolution 2021 of 2016 and subsequent updates. Recent reforms have focused on digitizing submissions through the INVIMA online platform, streamlining the NSO process for low-risk devices, and aligning pharmacovigilance and post-market surveillance requirements more closely with international standards.

Public procurement of health products in Colombia operates through a layered system involving the Ministry of Health and Social Protection, the Social Security Institute (through the Entidades Promotoras de Salud, EPS), and decentralized territorial entities at the departmental and municipal levels. The national benefits package, known as the Plan de Beneficios en Salud (PBS), defines which medicines, devices, and diagnostics are reimbursable within the mandatory health insurance system (Sistema General de Seguridad Social en Salud, SGSSS). Inclusion in the PBS is governed by the Institute for Health Technology Assessment (IETS), which conducts health technology assessments (HTA) to inform listing and pricing decisions. Public tenders are conducted under Law 80 of 1993 and Law 1150 of 2007, with procurement processes managed through the national electronic platform SECOP (Sistema Electronico de Contratacion Publica), administered by Colombia Compra Eficiente. Centralized procurement agreements (Acuerdos Marco de Precios) negotiated by Colombia Compra Eficiente are increasingly used for standardized health products, reducing fragmentation across public entities.

The private sector in Colombia represents a significant share of health product consumption, operating through private clinics, pharmacy chains, and distributor networks largely outside centralized tender mechanisms. Pricing in the private channel is influenced by the Maximum Price Control system (control de precios) administered by the Ministry of Health for pharmaceuticals deemed of public health importance, established under Circular 03 of 2013 and subsequent updates. Internationally funded procurement channels also play a role, particularly for vaccines (through the PAHO Revolving Fund), HIV and tuberculosis medicines (through Global Fund-supported programs), and maternal and child health commodities supported by USAID and UNICEF. Colombia does not currently maintain explicit local manufacturing preference policies for general health product tenders, though the government has expressed strategic interest in strengthening domestic pharmaceutical and biomedical production capacity under its national industrial policy frameworks.