Chile

The Instituto de Salud Pública de Chile (ISP) is the primary national regulatory authority responsible for the evaluation, registration, and surveillance of health products, including pharmaceuticals, medical devices, in vitro diagnostics, and biological products. The ISP operates under the framework established by the Código Sanitario (Sanitary Code) and is governed by the Ministerio de Salud (MINSAL). The general approval process requires submission of a registration dossier to the ISP, which conducts a technical review covering safety, efficacy, and quality. Products must obtain a Registro Sanitario before they can be legally commercialized in Chile. Risk-based classification systems are applied to medical devices and diagnostics, with higher-risk products subject to more rigorous review pathways.

Key submission requirements include the appointment of a local legal representative (representante legal) or a designated technical responsible party (director técnico) who holds accountability for the product within Chile. Chile generally accepts dossiers structured according to the Common Technical Document (CTD) format for pharmaceuticals, and aligns increasingly with Pan American Health Organization (PAHO) and International Medical Device Regulators Forum (IMDRF) guidance for devices and diagnostics. Chile is a member of the Pan American Network for Drug Regulatory Harmonization (PANDRH) and has pursued progressive alignment with international regulatory standards. Notable recent reforms include the enactment of the Ley de Fármacos II (Law 21.198), which strengthened bioequivalence requirements, expanded generic drug substitution policies, and introduced stricter transparency and pricing disclosure obligations for pharmaceutical manufacturers and distributors.

Public procurement of health products in Chile is centrally coordinated through the Central de Abastecimiento del Sistema Nacional de Servicios de Salud (CENABAST), which acts as the primary purchasing agent for the public health network. CENABAST aggregates demand from the national health services (Servicios de Salud) and negotiates framework agreements and direct purchase contracts on behalf of public hospitals and primary care facilities operating under the Fondo Nacional de Salud (FONASA) system. The Ministerio de Salud (MINSAL) sets overarching health priorities and procurement policies, while individual health services and hospital networks may conduct their own complementary tenders for products not covered by CENABAST agreements. Public tenders are published through ChileCompra, the national public procurement platform (Mercado Público), which operates under Law 19.886 and mandates competitive, transparent bidding processes for all public entities.

The private sector represents a significant and growing procurement channel in Chile, driven by a well-developed private insurance market (ISAPRE system) and a network of private clinics and hospitals that procure independently through direct commercial agreements with distributors and manufacturers. Multinational group purchasing organizations and private hospital networks increasingly leverage regional or global supply agreements. While Chile is an upper-middle-income country and does not extensively rely on donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, USAID, or Gavi, these mechanisms may apply marginally for specific disease programs or public health initiatives. Chile does not currently impose formal local manufacturing preference policies in public tenders, though CENABAST negotiations and ChileCompra frameworks may incorporate sustainability and social responsibility criteria that can indirectly favor certain suppliers.