Peru is a growing Latin American market with increasing healthcare needs and demand for pharmaceuticals, medical devices, and health products.
The General Directorate of Medicines, Supplies and Drugs (DIGEMID – Dirección General de Medicamentos, Insumos y Drogas) under the Ministry of Health (MINSA) 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 Peru. DIGEMID requires product registration, import permits, GMP compliance, quality certificates (CPP, GMP), Spanish labelling, and local sanitary registration holder representation. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate DIGEMID requirements, prepare compliant dossiers, secure timely approvals, and achieve efficient market entry and sustained compliance in this dynamic Latin American market.
Get Peru Compliance Support
Preparation of regulatory dossiers (CTD format), supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for DIGEMID submissions.
End-to-end support for DIGEMID registration of medicines, medical devices, biologics, and health products in Peru.
Assistance with DIGEMID import/export authorizations, sanitary import permits, batch release certificates, and customs documentation.
Guidance on DIGEMID GMP requirements, quality assurance documentation, certificate support, and preparation for inspections.
Setup of pharmacovigilance systems, adverse event reporting to DIGEMID, periodic safety reporting, and risk management in Peru.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with DIGEMID post-registration requirements.
Spanish labelling review, DIGEMID-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local sanitary registration holder/agent requirements, DIGEMID liaison, regulatory follow-up, and ongoing compliance management in Peru.
Strategic market entry planning, DIGEMID pathway guidance, regulatory intelligence on Peru’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Peru — from DIGEMID product registration and import permits to pharmacovigilance, Spanish labelling, and sustained Latin American market access.
Contact Our Peru Regulatory Experts