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07:46:392025-06-25

Certificates of export-free sale of sanitary products

HEADQUARTERS AEMPS > Procedures > Health 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 for 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 the status of the requests at all times.
Request for access

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

The access requests will reach the AEMPS, where, after being validated, the user will be registered and will be provided, via email, 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 Guide to Company Profile

Questions and answers about the application

Characteristics of the client equipment

What authentication methods will be needed?

  • Digital certificate
  • Electronic DNI
  • Cl@ve PIN
  • In some cases it will not be necessary to have any method of authentication

What characteristics do the client teams have to have?

  • Next generation browser: Edge, Chrome, Firefox, Safari or similar.
  • The use of Internet Explorer is not recommended.
  • Any PDF document viewer. You can download the Adobe Acrobat Reader at the address http://www.adobe.com/.
  • User authorization and password of RPS.
  • Application security: activate the Java Script option in the browser if it is not active (this option comes by default).

Since it is a Web application, there are no operating system or memory or disk requirements beyond those necessary for the operating system, browser and PDF viewer chosen.

What are the security elements that the applications incorporate?

  • 128-bit SSL communications encryption.
  • User authentication using USER and password.
  • Autenticación de usuario de segundo nivel, mediante TOKEN UNICO por solicitud que el usuario debe introducir para el envío de las mismas.
  • Each external user can only access the data of the entity it represents.
  • Log of accesses and audit of modifications (it is known who modifies and what).
  • Time out of connection.
Notification of errors

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