Medical Device Registration and Approval in Spain

General country-specific regulatory information is provided on this page for medical device registration and approval in Spain. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Spain, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Spain

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.

SPECIAL REQUIREMENTS:

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.

LOCAL FEES:

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.

Last updated on April 17, 2019.

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