Operating Licence: Manufacturer’s Licence and Importer’s Licence.

The “Licencia previa de funcionamiento de instalaciones de productos sanitarios” is required for Spanish companies whose activities include:

• Serial
•  Groupers
• Third-party
•  Importers

Of:

• Medical devices and their
• Active implantable medical
• In vitro diagnostic medical devices and their
• Non-corrective contact lenses (not considered as medical devices).
• Devices and instruments used for permanent make-up, semi-permanent make- up or tattooing of the skin by invasive

The procedure for obtaining the “Pre-licence for operation of medical device facilities” is an obligation for these actors related to the detailed devices and is established through the procedure set up by the Agency itself. But only for Spanish companies.

In this procedure, clarifications are provided on the procedure to be followed to obtain the prior licence for entities and facilities provided for in the royal decrees on medical devices, which is granted by the Spanish Agency for Medicines and Medical Devices (AEMPS).

deviCE Sistemas offers manufacturers, importers, sterilisers and groupers of Medical Devices and Medical Devices for in vitro diagnostics located in Spain, the preparation of all the documentation required to obtain the Preliminary Licence for the operation of facilities granted by the AEMPS (Spanish Agency for Medicinal Products and Medical Devices for In Vitro Diagnostics). These economic agents need the Preliminary Facility Operating Licence as part of the CE marking process for medical devices or in vitro diagnostic medical devices.

The Medical Device Manufacturer’s Licence is the most sought after licence and perhaps the one that needs the most attention. However, the Medical Device Importer’s Licence is also of great importance and, on many occasions, unknown. All companies located in Spain and importing Medical Devices, i.e. bringing in Medical Devices from outside the European Union, must obtain the Operating Licence granted by the AEMPS.

How can deviCE systems help you?

We help and accompany you in generating all the documentation and establishing records, as this authorisation procedure will require the AEMPS to verify that the applicant company and, where appropriate, subcontracted companies have the facilities, means, procedures and personnel required to carry out the activities in question. Applicants must therefore provide documentation together with the application to prove that they have these facilities, means, procedures and personnel in place.

deviCE Sistemas will be responsible for the generation or supervision of the numerous documentation to be submitted, which must be exhaustive and adequate to demonstrate the requirements set by the AEMPS.

deviCE Sistemas will take care of all the administrative procedures involved in this application, including the processing of the established fees, as well as the telematic processing of all the documentation.

How can deviCE systems helps you?