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07:49:092025-06-25

Application for prior operating licence for medical device installations

HEADQUARTERS AEMPS > Procedures > Health Products, Cosmetics, Personal Care and Biocides > Installations PS
Access to the app
Target persons

To all companies in the health products sector.

Request for access

The access is made through the electronic headquarters of the AEMPS with a username and password that will be provided by the AEMPS upon request by the interested parties.

Companies that have a previous operating licence granted by the AEMPS or the AEMPS has been requested prior to the implementation of the application and is in the process, must select the option ‘Company with licence’ and fill in the fields that are requested, as well as provide the document by which the legal representative of the company authorizes the applicant to access the application on behalf of the company.

Companies that request prior operating license for the first time, must select the option “register as a new company” and fill in the fields that are requested.

The 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.

Documentation
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.
Answers to frequently asked questions (FAQs)

Application security: activate the Java Script option in the browser if it is not active (this option comes by default).

PDF viewer: Adobe Acrobat Reader is recommended. It is possible to download it in the address.

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

Notification of errors

Data

Any error both related to the functionality and the data collected in the application must be communicated to the AEMPS through email.psinstal@aemps.es.

Functionality

Follow the same instructions described in the previous section.