Chile is one of the most stable and advanced markets in Latin America, with high demand for innovative pharmaceuticals, medical devices, and health products.
The Public Health Institute of Chile (ISP – Instituto de Salud Pública) is the national regulatory authority responsible for the registration, importation, distribution, quality control, pharmacovigilance, and post-market surveillance of medicines, medical devices, cosmetics, and biologics in Chile. ISP requires product registration, import permits, GMP compliance, quality certificates (CPP, GMP), Spanish labelling, and often a local representative or sanitary registration holder. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate ISP requirements, prepare compliant dossiers, secure timely approvals, and achieve efficient market entry and sustained compliance in this high-potential Latin American market.
Get Chile Compliance Support
Preparation of regulatory dossiers (CTD format), supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for ISP submissions.
End-to-end support for ISP registration of medicines, medical devices, biologics, and health products in Chile.
Assistance with ISP import/export authorizations, sanitary import permits, batch release certificates, and customs documentation.
Guidance on ISP GMP requirements, quality assurance documentation, certificate support, and preparation for inspections.
Setup of pharmacovigilance systems, adverse event reporting to ISP, periodic safety reporting, and risk management in Chile.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with ISP post-registration requirements.
Spanish labelling review, ISP-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local sanitary registration holder/agent requirements, ISP liaison, regulatory follow-up, and ongoing compliance management in Chile.
Strategic market entry planning, ISP pathway guidance, regulatory intelligence on Chile’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Chile — from ISP product registration and import permits to pharmacovigilance, Spanish labelling, and sustained Latin American market access.
Contact Our Chile Regulatory Experts