In Spain, economic operators that manufacture and/or market medical devices or perform related activities, must comply with both European requirements and national requirements established in the Royal Decree 192/2023.
This article outlines the key requirements related to licenses, communication of the commercialization of medical devices, and distributor obligations.
If you require any further information, contact us at: [email protected]
Download here:
Share
Services
SDGs
As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
Memberships & PartnershipS
Quality Management System
Innovative SME
SDGs
As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
© Asphalion
Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
We will be happy to assist you!
