Peru

In Peru, the primary regulatory authority for health products, including pharmaceuticals, medical devices, diagnostics, and digital health tools, is DIGEMID, operating under MINSA. The main governing legislation is the Ley General de Salud (Ley N° 26842) and its complementary regulations, including Decreto Supremo N° 016-2011-SA, which establishes the regulatory framework for pharmaceutical products and medical devices. The approval process generally requires product registration (Registro Sanitario) prior to commercialization, with distinct pathways depending on product category: new chemical entities, biologics, generics, and medical devices each follow specific technical and administrative routes. DIGEMID also maintains an accelerated review pathway for products addressing public health priorities or rare diseases.

Applicants must appoint a locally established legal representative or a Peruvian-registered company to act as the technical director responsible for the registration dossier. Peru accepts submissions aligned with the Common Technical Document (CTD) format, and as a member of the Pan American Network for Drug Regulatory Harmonization (PANDRH), it increasingly references regional harmonization standards. Peru also recognizes marketing authorizations from stringent regulatory authorities (SRAs) such as the FDA, EMA, and Health Canada, which can facilitate an abbreviated or expedited review process. In recent years, DIGEMID has advanced digitization of submission processes through its online platform (VUCE, Ventanilla Unica de Comercio Exterior) and has introduced reforms to streamline renewal procedures and post-market surveillance requirements, reducing administrative backlogs and improving transparency.

Public procurement of health products in Peru is centrally coordinated through MINSA and its procurement arm, CENARES (Centro Nacional de Abastecimiento de Recursos Estrategicos en Salud), which manages strategic purchasing of pharmaceuticals, medical devices, and diagnostics for the national health system. Public tenders are governed by the Ley de Contrataciones del Estado (Ley N° 30225) and overseen by OSCE (Organismo Supervisor de las Contrataciones del Estado). Regional health authorities (Direcciones Regionales de Salud, DIRESA) also conduct their own procurement processes for regionally managed health programs, creating a dual central-regional procurement structure. EsSalud, the social health insurance institution covering formal-sector workers, operates an independent procurement system with its own tender processes and supplier agreements. Products must hold a valid Registro Sanitario issued by DIGEMID to be eligible for public procurement.

The private sector represents a significant and growing channel in Peru, served through pharmaceutical distributors, retail pharmacy chains, and private hospital networks, particularly in Lima and other urban centers. International donor and multilateral procurement channels also play a role, especially for communicable disease programs: UNICEF, the Global Fund, and USAID/PEPFAR support procurement of HIV, tuberculosis, and malaria-related products through government and NGO partners. Peru has historically benefited from PAHO Strategic Fund mechanisms for vaccine and essential medicine procurement. While there is currently no formal local manufacturing preference law equivalent to some other markets, the government has expressed policy interest in strengthening domestic pharmaceutical production capacity, and MINSA has explored agreements to incentivize local manufacturing partnerships, particularly in the wake of the COVID-19 pandemic.