Operating License: Manufacturer License and Importer License.
The Preliminary Operating License for Medical Device Facilities is necessary for companies whose activities include:• Serial manufacturers.• Assemblers.• Third-party sterilizers.• Importers.Of:• Medical devices and their accessories.• Active implantable medical devices.• In vitro diagnostic medical devices and their accessories.• Non-corrective contact lenses (not considered medical devices).• Equipment and instruments used for permanent, semi-permanent makeup or skin tattooing by invasive techniques.
The procedure for obtaining the Preliminary Operating License for Medical Device Facilities is a requirement for these actors related to the detailed products and is established through the procedure set by the Agency itself.This procedure provides clarifications on the steps to follow to obtain the preliminary license for entities and facilities as provided in the royal decrees of medical devices, whose granting is the responsibility of the Spanish Agency of Medicines and Medical Devices (AEMPS).
deviCE Sistemas (Vitoria-Gasteiz) offers manufacturers, importers, sterilizers, and assemblers of Medical Devices and In Vitro Diagnostic Medical Devices located in Spain, the preparation of all necessary documentation for obtaining the Preliminary Operating License for Facilities granted by AEMPS. These economic agents need the Preliminary Operating License for Facilities as part of the CE Marking process for Medical Devices or In Vitro Diagnostic Medical Devices.The manufacturer license for Medical Devices is the most requested license and perhaps the one that requires the most attention. However, the Importer License for Medical Devices is also of great importance and often unknown. All companies located in Spain that import Medical Devices, meaning bringing Medical Devices from outside the European Union, must obtain the Operating License granted by AEMPS.
We offer you MDR and IVDR medical device services.
How can deviCE sistemas help you?
We help and accompany you to generate all the documentation, and the establishment of records since this authorization procedure will require confirmation by AEMPS that the applicant company and, if applicable, subcontracted companies have the facilities, means, procedures, and adequate personnel to carry out the activities in question, so applicants must provide documentation that evidences their availability along with the application.deviCE Sistemas will be responsible for the generation or supervision of the extensive documentation that must be submitted and must be exhaustive and adequate to demonstrate the requirements set by AEMPS.deviCE Sistemas will handle all the administrative procedures involved in this application, including the processing of the established fees, as well as the online processing of all documentation.
