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00:05:132026-08-16

Registration of persons responsible for placing medical devices on the market

AEMPS HEADQUARTERS > Procedures > Medical Products, Cosmetics, Personal Care and Biocides > RPS
Access to the app
Target persons
  • Manufacturers of made-to-measure medical devices, of any classification, that put made-to-measure products on the market.
  • Representatives authorized by manufacturers of custom-made medical devices of any kind, established in Spain, must report their introduction into the market, regardless of the country in which it is marketed.
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

User Manual

Frequently asked questions

Characteristics of the client teams

What authentication methods will be needed?

  • Digital certificate
  • Electronic ID
  • 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 (you know who modifies and what).
  • Time out of connection.
Notification of errors
If you experience errors or difficulties with the application, contact us through: ServiceDeskAEMPS Where they can give you computer support.

For any regulatory questions that may arise, please address your query to the email addressrps@aemps.es.