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 digital health solutions. The main governing legislation is the Código Sanitario (Decreto con Fuerza de Ley No. 725 of 1968) and its complementary regulations, including Decreto Supremo No. 3 of 2010 for pharmaceuticals and Decreto Supremo No. 825 of 1998 for medical devices. All health products intended for commercialization in Chile must obtain a Registro Sanitario (sanitary registration) prior to market entry, granted following a technical dossier review by the ISP. The approval process involves submission of technical, clinical, and manufacturing documentation, along with product samples where required, and products are evaluated for safety, efficacy, and quality.

Applicants must designate a local legal representative or importer domiciled in Chile who assumes regulatory responsibility before the ISP. Dossier submissions generally follow the Common Technical Document (CTD) format for pharmaceuticals, and the ISP increasingly accepts international reference documents from recognized regulatory authorities such as the FDA, EMA, and Health Canada to streamline review. Chile is a member of the Pan American Network for Drug Regulatory Harmonization (PANDRH) and participates in regional convergence initiatives, which has influenced the gradual alignment of its requirements with international standards. A notable reform is Law No. 20.724 (2014), which strengthened bioequivalence requirements and generic drug policies, and more recently, the government has advanced regulatory modernization efforts including electronic submissions and expedited pathways for priority health products.

Public procurement of health products in Chile is centrally coordinated through the Central de Abastecimiento del Sistema Nacional de Servicios de Salud (CENABAST), which operates under the Ministry of Health (Ministerio de Salud, MINSAL). CENABAST acts as a procurement intermediary, negotiating and purchasing pharmaceuticals, medical devices, and other health supplies on behalf of public health facilities and the 29 regional Health Services (Servicios de Salud) distributed across the country. Procurement processes are governed by Law No. 19.886 on Public Procurement and must be conducted through the ChileCompra platform (Mercado Público), ensuring transparency and competitive tendering. Large-scale national tenders are managed centrally, while individual Health Services and hospitals may conduct complementary direct or framework agreement purchases for locally managed budgets. The Fondo Nacional de Salud (FONASA) plays a key role in reimbursement and coverage decisions that influence procurement volumes within the public system.

The private health sector, regulated through Instituciones de Salud Previsional (ISAPRES), procures health products independently through commercial channels and distributor agreements, representing a significant parallel market particularly for higher-value medical devices, diagnostics, and digital health technologies. Chile is an upper-middle to high-income country and does not extensively rely on multilateral donor-funded procurement mechanisms such as UNICEF Supply Division, the Global Fund, or USAID health commodity programs; however, participation in PAHO revolving fund mechanisms for vaccines and select essential medicines provides cost advantages for the public sector. Local manufacturing of pharmaceuticals exists but is limited in scale, and while there is no formal mandatory local manufacturing preference policy, CENABAST tender criteria may incorporate factors such as supply security and national production capacity. Chile has also signed free trade agreements with numerous countries, which reduces import tariffs on many health products and facilitates market access for international manufacturers.