Spain is a key European market with robust healthcare infrastructure, efficient regulatory pathways, and direct access to the entire EU.
The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) regulates national procedures and collaborates with EMA for centralized authorizations. Medwisdom LifeScience provides expert support to ensure fast, compliant market entry and long-term regulatory success in Spain.
Get Spain Compliance Support
PSMF setup, PSUR/PBRER submission, signal detection, local QPPV support.
MDR/IVDR conformity assessment, Notified Body liaison, vigilance reporting.
Local MAH representation, AEMPS liaison, lifecycle management.
PMS plans, trend reporting, FSCA notification, vigilance compliance.
Spanish labelling review, Blue Box requirements, mock-ups, readability testing.
CPNP notification, Responsible Person services, safety assessments, claim substantiation.
Partner with Medwisdom for fast, reliable, and compliant regulatory support in Spain — from registration to post-market success.
Contact Our Spain Regulatory Experts