Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
November 2, 2025
Approximately 5 minutes
Practical Keys to Commercializing Medical Devices in Spain: AEMPS Notification
Essential Steps for Medical Device Commercialization in Spain
To legally market and sell medical devices in Spain, manufacturers must navigate the regulatory landscape set by the European Medical Device Regulation (EU MDR) and enforced nationally by the Spanish Agency for Medicines and Medical Devices (AEMPS). These practical steps are non-negotiable for compliance.
1. Mandatory National Notification to AEMPS
While the CE Mark allows free movement of goods, Spain requires a national notification for market surveillance purposes.
- AEMPS Registration: All devices placed on the Spanish market must be notified to the AEMPS database. This applies to devices of all risk classifications (Class I, IIa, IIb, III).
- Notification Responsibility: For non-EU manufacturers, the EU Authorized Representative (AR) is legally responsible for submitting this notification to the AEMPS on the manufacturer's behalf. This process ensures the AR is properly registered in Spain to act as the legal point of contact.
2. Strict Language Compliance (Spanish Mandate)
One of the most critical practical requirements for commercialization in Spain is language compliance.
- Spanish Language Requirement: All documents necessary for the safe and proper use of the device, including Instructions for Use (IFUs), labeling, and technical promotional materials targeting end-users and patients, must be provided in the Spanish language. This is an absolute national prerequisite for legality.
- Accuracy: Translations must be accurate and use the correct technical terminology to avoid non-compliance actions by AEMPS.
3. Vigilance and Post-Market Duties
AEMPS maintains strict oversight post-market, demanding prompt action from manufacturers and their AR.
- Vigilance Reporting: The AR must promptly report any serious adverse incidents or Field Safety Corrective Actions (FSCAs) occurring in Spain to the AEMPS.
- Market Surveillance: AEMPS actively monitors the market and may request additional documentation or clarification on registered devices. Manufacturers must ensure their technical files and QMS records are readily available to the AR for communication with the Spanish authority.