Peru

In Peru, the primary regulatory authority for health products, including pharmaceuticals, medical devices, diagnostics, and related health technologies, is DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), which operates under the Ministerio de Salud (MINSA). The overarching legal framework is established by Ley N° 29459 (Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios) and its associated regulations, principally Decreto Supremo N° 016-2011-SA and Decreto Supremo N° 002-2018-SA. All health products intended for the Peruvian market must obtain a Registro Sanitario (sanitary registration) prior to commercialization. The approval process involves technical dossier submission, safety and efficacy review, labeling assessment, and, for certain product categories, good manufacturing practice (GMP) verification of the manufacturing site.

Applicants are required to appoint a local legal representative or a duly registered Peruvian company to submit and maintain the Registro Sanitario on behalf of foreign manufacturers. Dossiers are generally accepted in the Common Technical Document (CTD) format, aligned with ICH guidelines, though DIGEMID also recognizes regional Pan American Health Organization (PAHO) standards and accepts reference approvals from stringent regulatory authorities (SRAs) such as the US FDA, EMA, and Health Canada as supporting evidence, which can facilitate expedited review pathways. Recent reforms have focused on digitizing submission processes through the VUCE (Ventanilla Única de Comercio Exterior) platform, strengthening pharmacovigilance and post-market surveillance requirements, and implementing risk-based classification frameworks for medical devices and diagnostics in closer alignment with IMDRF and PAHO recommendations.

Public procurement of health products in Peru is centrally coordinated through MINSA and its procurement arm, with EsSalud (the social health insurance system) operating as a parallel major purchaser for its affiliated population. The national procurement framework is governed by Ley N° 30225 (Ley de Contrataciones del Estado) and overseen by OSCE (Organismo Supervisor de las Contrataciones del Estado). CENARES (Centro Nacional de Abastecimiento de Recursos Estratégicos en Salud) serves as the central logistics and strategic stockpiling entity under MINSA, coordinating national tenders and framework agreements for essential medicines, medical devices, and diagnostics. Regional health authorities (DIRESA and GERESA) may conduct their own procurement processes for sub-national needs, creating a layered public purchasing structure that requires suppliers to engage at both national and regional levels.

The private healthcare sector in Peru is significant and growing, comprising private clinics, pharmacy chains such as InkaFarma and MiFarmacias, and private hospitals that procure independently through direct supplier negotiation and distributor networks. International donor and multilateral channels also play a role, particularly for public health programs: PAHO and UNICEF support procurement for immunization and essential health commodities, while the Global Fund finances procurement of HIV, tuberculosis, and malaria-related products through coordinating mechanisms linked to MINSA. USAID and other bilateral donors periodically fund health commodity supply through implementing partners. Peru does not currently have strong statutory local manufacturing preference policies, but national industrial promotion strategies under PRODUCE and evolving public health priorities are increasingly encouraging domestic production capacity, particularly following supply chain vulnerabilities highlighted during the COVID-19 pandemic.