We can help you with regulatory compliance according to your role
IMPORTER
DISTRIBUTOR
AFTER-SALES SERVICING
REGULATORY ROADMAP & REGULATORY STATUS GAP
See the difference:
A fully Spanish consulting firm certified to ISO 13485
We reduce time to the Spanish market, minimize regulatory risks, and optimize certification costs
RECO PS
(data entry)
CINA PS
(public)
RPS
(custom made)
LICENSES
(AEMPS)
Meet us at #MEDICA2026 – @MEDICAtradefair 16-19 Nov 2026, see you there …
MEDICA remains a major European gathering where we participate alongside many of our clients. With more than 4,800 exhibitors from 70 countries and 78,000 visitors, MEDICA in Düsseldorf, along with WHX Dubai (formerly Arab Health), is one of the world’s largest B2B medical trade shows.
We are always delighted to meet our clients at the trade show, whether they are exhibitors or visitors.
This year, there are 104 Spanish exhibitors,
and we’ll be at the ACCIÓ – Catalonia Trade & Investment booth in Hall 15, F07-2.
See you there!! 
Tecno-med provides regulatory services for non-Spanish economic operators seeking to make available medical devices on the Spanish market
Visit our website: https://www.tecno-med.es/en/tecno-med_eng/
Any economic operator making available medical devices in Spain must, in addition to being registered with EUDAMED, be included in the RECOPS commercialisation register maintained by the Spanish Agency for Medicines and Health Products (AEMPS).
We provide a Regulatory Status GAP Report of your Spanish branch offices or distributors. Contact us
Gran asistencia al RAPS LNG Spain “EUDAMED y registro nacional RECOPS en España / EUDAMED and Spanish national database RECOPS” 24 July 2026 GRACIAS!!!
Con mas de 95 asistnetes fue un placer. Muchas gracias / With more than 95 attendees, it was a pleasure. Many thanks.
Cualquier agente económico que comercialice productos sanitarios en territorio español, además de estar registrado en EUDAMED, debe estar incluido en el registro de comercialización RECOPS de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Tambien os actualizaremos requisitos EUDAMED. En esta sesión virtual, os explicaremos los pasos necesarios para cumplir estas obligaciones y mantener el cumplimiento regulatorio en toda la cadena de suministro.
Any economic operator making available medical devices in Spain must, in addition to being registered with EUDAMED, be included in the RECOPS commercialisation register maintained by the Spanish Agency for Medicines and Health Products (AEMPS). Also we will update on the EUDAMED requirements. In this webinar, we will explain the steps required to meet these obligations and maintain regulatory compliance throughout the supply chain
