ES-AEMPS-REG

AEMPS registration (Spain)

Registration with the Spanish agency for medicines and medical devices

Category
National requirements
Market
Spain
Applicable classes
Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device

In practice

Responsible declaration before commercialisation, through the REGPS general register of medical devices.

Official sources

https://www.aemps.gob.es/industria-y-autorizaciones/productos-sanitarios/

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