All the companies that are dedicated in Spain to the activity of:
- Serial manufacture of medical products.
- Customised manufacturing in the Autonomous Cities of Ceuta and Melilla.
- Grouping of health products.
- Sterilizers and/or third party sterilizers.
- Importers of health products established in Spain.
They must have a prior operating licence document issued by the Spanish Agency for Medicines and Healthcare Products (AEMPS) as a compulsory requirement for carrying out the company's activity in Spain.
In the case of manufacturers of custom-made medical devices, the application for a prior operating licence will be requested from the health authorities of the corresponding Autonomous Community.
In the case of only being distributors, they must communicate the distribution activity in the Autonomous Community where the company is established.
In all cases, the company must have a responsible technician and communicate the placing on the market of its products.
In Azierta we can help you in the preparation of the necessary documentation for the application and processing of the licences and communications for placing your products on the market.