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03:54:352026-11-02

Export Certificates - Free Sale of Medical Devices

AEMPS HEADQUARTERS > Procedures > Medical Products, Cosmetics, Personal Care and Biocides > CERTPS
Access to the app
Target persons

Companies established in Spain that have the status of manufacturer, importer, grouper, authorised representative in the European Union or distributor of medical devices, active implantable medical devices and in vitro diagnostic medical devices that export to countries outside the European Union

The objective of the CERTPS application is to facilitate the management of export-free sales certificates of health products issued by the Department of Health Products of the Spanish Agency of Medicines and Health Products.

Through this application you can:

  1. Submit applications for export certificates for medical devices.
  2. Correct the possible incidents in the request, if necessary, until the issuance of the certificate.
  3. Desist from an application for an export certificate.
  4. Download the certificates issued by the AEMPS.
  5. Renew the request for new certificates from other previously issued certificates.
  6. Check at all times the status of the applications.
Request for access

Entities must request access credentials (user and password) through the link located on the entry screen in the application.

Access requests will reach the AEMPS, where, after being validated, the user will be registered and will be provided, via email, with the username and password with which you can access the application.

The entity shall be responsible for the custody and management of the use of these credentials within its organization. To prevent fraudulent use by people who have lost the ability to access the application, the password must be changed each time these circumstances occur.

In any case, it is recommended to change the password frequently, and always the first time the application is accessed.

The system will communicate the access keys automatically to the email address provided by the users.

Documentation

Enterprise User Manual

Quick Company Profile Guide

Questions and answers about the application

Characteristics of the client teams

What authentication methods are needed?

What characteristics should the computer equipment have?

  • Updated web browser (Microsoft Edge, Google Chrome, Mozilla Firefox, Safari or similar).
  • Any PDF document viewer. Adobe Acrobat Reader can be downloaded at the address https://www.adobe.com/.

  • Application security: enable the JavaScript option in your browser if it is not enabled (this option is enabled by default).

    As it is a web application, there are no specific requirements for operating system, memory or storage capacity, beyond those necessary for the operation of the operating system, browser and PDF viewer used.

What are the security elements that the applications incorporate?

  • 128-bit SSL communications encryption.
  • Autenticación de usuario de segundo nivel, mediante un token único por solicitud que deberá introducirse para su envío.
  • Each external user can only access the data of the entity they represent.
  • Log of accesses and audit of modifications, which allows to identify who makes each modification and what changes have been made).
  • Connection waiting time (timeout).
Notification of errors

Any errors related to functionality must be communicated to the AEMPS via e-mail.soportecertps@aemps.es.