::: Services - Medical devices - Authorization of medical devices facilities :::
Authorization of
medical devices facilities
- Completing the Feature Request Authorization of Medical Facilities and presentation in the AEMPS.
- Completing the Dossier Communication Company Distributor of Medical Supplies and presentation in the Autonomous Community.
- Search of Technical Person in charge.
- Search of subcontractors.
- Conducting quality audits on facilities on the documentation, or global.
- etc.
MANUFACTURING - IMPORT - GROUPING - STERILIZATION
According to Spanish legislation of medical devices, companies located in Spanish territory to pursue one of the manufacturing, importation, packaging and / or sterilization of medical devices should be approved for facilities granted by the General Product health of the Spanish Agency of Medicines and Health Products (AEMPS).
DISTRIBUTION
The companies that distribute medical devices, are required to make a communication, or request an authorization (under the Autonomous Region) to the health authorities of the Autonomous Community where the company is located. The distribution is independent of manufacturing, importing, packaging and sterilization, and the companies authorized to distribute these devices, they also make distribution of this communication.
