Spain · Spanish Agency of Medicines and Medical Devices · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
-
Makers of custom-made devices, such as orthopedic or dental products, need an operating licence from the health authority of their region, not from the national agency. Makers that place custom-made devices on the market, and authorized representatives in Spain, also register with the agency's register of persons responsible. Manufacturing custom-made devices for named patients in Spain.
1. Regional operating licence; 2. Register with the national agency; 3. Report changes.
Outcome: A regional operating licence and an entry in the national register of persons responsible for custom-made devices.
Legal basis: Real Decreto 192/2023, articles 10 and 21
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Spain: Marketing registration of devices and IVDs in Spain (RECOPS), Prior operating licence for device manufacturers and importers, In-house devices made by hospitals and health centers. See all routes on the Spain page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.