Spain · Spanish Agency of Medicines and Medical Devices · Medical devices
Review target
-
Not published
Legal time limit
91 days
regulation
Steps
5
4 requirements
Application fee
€984
2023 onward
On top of EU device rules, Spain requires a prior operating licence from the agency for anyone who makes, imports, groups or sterilizes medical devices, and for those who make, import or sterilize in vitro diagnostics. The agency must decide within three months. The licence lasts up to five years and can be renewed. Manufacturers, importers (including those who physically import into Spain), operators that group devices and sterilizers of devices, and manufacturers, importers and sterilizers of in vitro diagnostics.
The operating licence for device manufacturing, sterilization or reprocessing sites is €984 for 2023 onward.
1. Electronic application; 2. Review of documents (91 days); 3. Inspection report (may pause the clock) (91 days); 4. Licence decision; 5. Revalidation and changes.
Outcome: One licence covering the company's facilities and activities, valid for up to five years. Valid for 5 years.
Legal basis: Real Decreto 192/2023, articles 7 and 8; Real Decreto 942/2025, articles 7 and 8
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).
About 182 days end to end with the official step targets, of which up to 91 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Legal time limitregulation. About three months from filing. This is an official time limit, not an actual review time. | 91 days |
| Longest clock stopregulation. The request for an inspection report can pause the procedure for up to three months. | 91 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Operating licence for device manufacturing, sterilization or reprocessing sitesEstablishment · 2023 onward | €984 |
| Operating licence for device import or grouping sitesEstablishment · 2023 onward | €492 |
Other routes in Spain: Marketing registration of devices and IVDs in Spain (RECOPS), Custom-made devices: regional licence and national register, 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 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.