Chile

The Instituto de Salud Pública de Chile (ISP) is the primary national regulatory authority responsible for the evaluation, registration, and post-market surveillance of health products, including pharmaceuticals, medical devices, diagnostics, and increasingly digital health solutions. The principal governing legislation is the Código Sanitario (Sanitary Code) and its associated regulations, most notably the Decreto Supremo N° 3 of 2010 for medical devices and Decreto Supremo N° 1 of 2013 for pharmaceuticals, along with subsequent amendments. Regulatory approval is mandatory prior to commercialization, and the ISP conducts technical evaluations covering safety, efficacy, and quality before granting a sanitary registration (Registro Sanitario). Risk-based classification frameworks guide the depth of review, with higher-risk products subject to more rigorous scrutiny.

Applicants must appoint a legally recognized local technical representative (Director Técnico) domiciled in Chile, who bears regulatory responsibility for the product on the market. Dossiers generally follow CTD-aligned formats for pharmaceuticals, while medical device submissions reference ISO standards and, where applicable, technical files equivalent to CE marking documentation. Recognition of foreign approvals from stringent regulatory authorities, such as the FDA, EMA, and Health Canada, can facilitate expedited review pathways under Chile's referencing procedures. The ISP has undertaken ongoing modernization reforms, including digitalization of submission portals and alignment with the Pan American Network for Drug Regulatory Harmonization (PANDRH) and the International Medical Device Regulators Forum (IMDRF) frameworks, aimed at reducing administrative burdens and improving review timelines.

Chile operates a centralized public procurement structure primarily overseen by the Ministerio de Salud (MINSAL) and its executing arms, particularly la Central de Abastecimiento del Sistema Nacional de Servicios de Salud (CENABAST). CENABAST functions as the central purchasing agency for the public health system, procuring pharmaceuticals, medical devices, and diagnostic products on behalf of hospitals, primary care centers, and the national network of Servicios de Salud (regional health services). Public tenders are conducted through the national electronic procurement platform, ChileCompra (Mercado Público), in accordance with the Ley N° 19.886 on public procurement, which mandates transparency, open competition, and non-discrimination. While CENABAST centralizes high-volume strategic procurement, individual health services and hospital facilities retain the ability to conduct their own tenders for specialized or locally specific needs, creating a dual-layered procurement dynamic.

The private sector in Chile is substantial and represents a significant parallel market channel, with large private hospital networks, clinics, and pharmacy chains (including major chains such as Farmacias Ahumada, Cruz Verde, and Salcobrand) procuring independently through direct commercial negotiations. Chile's relatively high income status means that donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, Gavi, or USAID are not primary market entry routes, though they may play a minor role in specific public health programs targeting infectious diseases or vulnerable populations. Chile has shown limited formal local manufacturing preference policies compared to some regional peers, though CENABAST tender criteria can incorporate factors such as supply reliability and local distribution capacity. Ongoing discussions at the ministerial level around health technology assessment (HTA), led by the Departamento de Evaluación de Tecnologías Sanitarias within MINSAL, are increasingly influencing procurement decisions and reimbursement inclusion under the public Fondo Nacional de Salud (FONASA) system.