REGULATORY AUTHORITY: Devices are regulated by the Spanish Agency of Medicines and Health Products (AEMPS).
CLASSIFICATION SYSTEM: Medical devices are classified according to the EU risk based classification system.
Medical Devices: Class I, IIa, IIb, III.
IVD Devices: List A & B annex II, Self testing IVD, all others.
TIMEFRAME: Class I registration is not required. The notification process, for medical and IVD devices, takes 2 – 3 months after submission of documents until receiving a communication from the Spanish Authority that the legal requirement has been met and the product can be distributed. The complete formal review and final inclusion in the Spanish database might take up to 6 months.
Audits: There are no special audit requirements.
Technical Local Tests: There are no local testing requirements.
Clinical Evaluation/studies: There are no clinical studies requirements.
Application review fees: None
Manufacturer registration: None
LICENSE VALIDITY: License validity is based on the validity of the CE Certificate.
LICENSE TRANSFER: Not applicable in Spain.
AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative anywhere in the European Union is required.