Chile

The Instituto de Salud Pública de Chile (ISP) is the primary national health regulatory authority responsible for the evaluation, registration, and surveillance of health products, including pharmaceuticals, medical devices, diagnostics, and biological products. The principal governing legislation is the Código Sanitario (Health Code) along with its associated decrees, most notably Decreto Supremo No. 3 (1985) for pharmaceuticals and Decreto Supremo No. 825 (1998) and subsequent resolutions for medical devices and diagnostics. The ISP operates under the oversight of the Ministerio de Salud (MINSAL) and manages the Registro Sanitario process, which is mandatory for all health products commercialized in Chile. The general approval pathway requires applicants to submit a dossier demonstrating safety, efficacy, and quality, followed by technical review by ISP evaluators before a Registro Sanitario number is granted.

Key submission requirements include the appointment of a local legal representative or technical director (Director Técnico) domiciled in Chile, who assumes regulatory and legal responsibility for the product. Chile generally aligns its dossier expectations with the Common Technical Document (CTD) format for pharmaceuticals, and the ISP increasingly accepts technical documentation structured according to international standards such as those from IMDRF for medical devices. Chile is a member of PANDRH (Pan American Network for Drug Regulatory Harmonization) and has bilateral recognition agreements with select regulatory authorities, which may facilitate abbreviated review pathways for products already approved by recognized stringent regulatory authorities (SRAs) such as the US FDA, EMA, or Health Canada. Recent reforms have focused on expedited pathways for innovative and priority health products, improvements to the electronic submission platform SISE (Sistema de Información para la Solicitud de Expedientes), and greater alignment with international harmonization frameworks to reduce duplicative requirements and shorten review timelines.

Public procurement of health products in Chile is governed primarily through the Ministerio de Salud (MINSAL) and its decentralized networks, including the Central de Abastecimiento del Sistema Nacional de Servicios de Salud (CENABAST), which is the central purchasing agency responsible for procuring, storing, and distributing pharmaceuticals, medical devices, and other health supplies to the public health network. CENABAST operates through framework agreements and competitive tenders, leveraging aggregated demand across the national public health system (Sistema Nacional de Servicios de Salud, SNSS) to negotiate favorable pricing. Public procurement is also subject to the rules of ChileCompra (Dirección ChileCompra), the national public procurement platform governed by Ley No. 19.886, which mandates transparent, competitive bidding processes for all public entities including hospitals, health services, and regional health authorities (Servicios de Salud). Regional and municipal health establishments (particularly primary care centers managed by municipalities, known as CESFAM) may conduct independent procurement within the CENABAST and ChileCompra frameworks, creating a layered but centrally anchored procurement structure.

The private health sector in Chile is substantial, serviced primarily through private hospitals, clinics, and the Instituciones de Salud Previsional (ISAPRE) network of private health insurers, which procure health products through direct commercial channels and private distributors. Private sector procurement is largely driven by commercial negotiations between manufacturers, importers, and private health institutions, without the mandatory tender requirements applicable to the public sector. Chile does not rely heavily on multilateral donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, or Gavi, given its upper-middle-income country status and relatively well-funded public health system; however, international organizations may play a role in specific public health programs or emergency responses. Chile does not currently maintain explicit domestic manufacturing preference policies that systematically advantage local producers in public tenders, though CENABAST framework agreements and ChileCompra processes may incorporate social and sustainability criteria. Efforts to strengthen local pharmaceutical manufacturing capacity have been discussed at the policy level, particularly following supply chain disruptions experienced during the COVID-19 pandemic.