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 EU list of Competent Authorities. Additionally, the Spanish Agency for Medicines and Medical Devices (AEMPS) must be informed before certain medical devices are placed on the market and/or put into service for the first time.

CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device. The registration process with AEMPS can take up to six months.

LICENSE VALIDITY: Licenses issued in the EU are valid for five years. Registration with AEMPS does not require renewal.

AUTHORIZED REPRESENTATIVE: An authorized representative anywhere in the European Union is required.

ADDITIONAL INFORMATION: The Medical Device Directive is due to be changed in 2015.

Last updated on March 17 2015.

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