Venezuela is a significant market in South America with ongoing demand for essential pharmaceuticals, medical devices, and health products despite economic challenges.
The National Institute of Hygiene "Rafael Rangel" (INHRR – Instituto Nacional de Higiene "Rafael Rangel") and the Autonomous Service of Intellectual Property (SAPI), under the Ministry of Popular Power for Health (MPPS), are key regulatory bodies responsible for the registration, importation, distribution, quality control, and post-market oversight of medicines, medical devices, and related health products in Venezuela. Requirements include product registration, import permits, GMP compliance, quality certificates (CPP, GMP), Spanish labelling, and local representation. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate these requirements, prepare compliant dossiers, secure approvals, and achieve market entry and compliance in this regional market.
Get Venezuela Compliance Support
Preparation of regulatory dossiers, supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for INHRR/MPPS submissions.
End-to-end support for registration of medicines, medical devices, and health products with INHRR/MPPS in Venezuela.
Assistance with import/export authorizations, sanitary import permits, batch release certificates, and customs documentation.
Guidance on GMP documentation, quality assurance requirements, certificate support, and preparation for quality inspections.
Setup of pharmacovigilance systems, adverse event reporting, periodic safety reporting, and risk management in Venezuela.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with post-registration requirements.
Spanish labelling review, specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local agent/representative requirements, MoH/INHRR liaison, regulatory follow-up, and ongoing compliance management in Venezuela.
Strategic market entry planning, regulatory pathway guidance, intelligence on Venezuela’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Venezuela — from product registration and import permits to pharmacovigilance, Spanish labelling, and sustained market access.
Contact Our Venezuela Regulatory Experts