Peru

In Peru, the primary regulatory authority for health products, including pharmaceuticals, medical devices, diagnostics, and digital health tools, is DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), operating under the Ministerio de Salud (MINSA). The overarching legislative framework is established by Ley N° 29459 (Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios) and its implementing regulations, principally Decreto Supremo N° 016-2011-SA for pharmaceuticals and Decreto Supremo N° 010-1997-SA for medical devices, with subsequent amendments. Market authorization is required for all regulated health products prior to commercialization, and DIGEMID conducts technical-scientific evaluations of submitted dossiers through its online registry platform, known as the Sistema de Registro Sanitario. Products from reference regulatory agencies, including the FDA, EMA, Health Canada, and others recognized by DIGEMID, may qualify for an expedited or facilitated registration pathway.

Applicants must appoint a local legal representative or a Peruvian-registered company (titular del registro sanitario) to hold and manage the sanitary registration. Dossiers are generally aligned with CTD (Common Technical Document) format for pharmaceuticals, while medical device submissions follow a risk-based classification system (Classes I through III) broadly consistent with GHTF/IMDRF principles. Peru is an active member of the Pan American Network for Drug Regulatory Harmonization (PANDRH) and participates in regional harmonization initiatives within the Andean Community (CAN), including mutual recognition efforts and shared technical guidelines. Recent reforms have emphasized digitalization of the submission process, stronger post-market surveillance requirements, and accelerated pathways for products addressing unmet public health needs, including provisions introduced during and after the COVID-19 pandemic for emergency health technologies.

Public procurement of health products in Peru is centrally coordinated through MINSA and its executing entities, most notably EsSalud (the social health insurance institution covering formal sector workers), the Seguro Integral de Salud (SIS) for subsidized populations, and regional health directorates (DIRESAs and GERESAs). Large-scale centralized purchasing is managed through CENARES (Centro Nacional de Abastecimiento de Recursos Estratégicos en Salud), which conducts national framework agreements and consolidated tenders for essential medicines, medical devices, and diagnostics on behalf of public health facilities. All public procurement follows the Ley de Contrataciones del Estado (Ley N° 30225) and is administered through the SEACE (Sistema Electrónico de Contrataciones del Estado) platform overseen by OSCE (Organismo Supervisor de las Contrataciones del Estado). Procurement decisions are informed by the PNUME (Petitorio Nacional Único de Medicamentos Esenciales) for pharmaceuticals and equivalent reference lists for devices and diagnostics.

The private sector represents a significant and growing channel in Peru, comprising private clinics, hospital networks, retail pharmacy chains, and diagnostic laboratories that procure independently through direct commercial agreements with distributors and manufacturers. Peru also benefits from donor-funded procurement channels: the Global Fund has historically supported HIV, tuberculosis, and malaria programs, with PARSALUD and PRONABI-linked mechanisms facilitating access; USAID and its implementing partners support supply chain strengthening and procurement of health commodities in priority areas; and PAHO (Pan American Health Organization) serves as a procurement agent for specific public health programs, particularly vaccines under the PAHO Revolving Fund. Local manufacturing preference policies exist but are limited in scope; the government has expressed ambitions to strengthen national pharmaceutical production capacity, and products manufactured domestically or within CAN member states may receive preferential considerations in certain tender evaluations, though full enforcement of such preferences remains inconsistent.