Spain Product Registration & Certification
Important Notes
- Regulatory Framework: Medical devices follow EU MDR/IVDR, supervised by the Spanish Agency of Medicines and Medical Devices (AEMPS); cosmetics follow EU Regulation EC 1223/2009.
- Authorized Representative: Non-EU manufacturers must appoint an EU/Spain-based Authorized Representative for registration, AEMPS communication, and post-market duties.
- Labeling & Language: All product labels, instructions, and advertising materials must be in Spanish (Castilian), with clear, accurate, and unambiguous information.
- National Registration & Database: After CE marking, medical devices must complete national registration in AEMPS's "Medical Devices Registration System (REGMED)" before marketing.
- Advertising & Claims Regulation: Advertising for medicines, devices, and cosmetics requires prior authorization or notification to AEMPS; claims must be substantiated by solid scientific evidence.
- Pricing & Reimbursement Process: Medicines and some devices must apply for pricing (PVA) and inclusion in the National Health System (SNS) reimbursement list, a complex and lengthy process.
Spain specific Requirements
- National Enforcement within EU Framework: Strict implementation of EU regulations; AEMPS is known for meticulous review and rigorous processes; national registration is a critical step.
- Highly Centralized Public Procurement: The National Health System (SNS) is the main purchaser. Reimbursement listing is key to market share but involves intertwined political and technical factors.
- Complexity from Regional Autonomy: The 17 autonomous communities have significant autonomy in healthcare management, budgeting, and procurement, requiring a central-regional coordinated strategy.
- Emphasis on Clinical & Economic Evidence: Reimbursement applications require local or applicable clinical effectiveness evidence and pharmacoeconomic evaluation to demonstrate product "value".
- Consumer Preferences & Channel Dynamics: Pharmacy (Farmacia) channel is powerful with high consumer trust in pharmacist recommendations; e-commerce is growing but under tightening regulation.
Medical Devices Registration
Regulatory Requirements
- CE Marking Certification (according to MDR)
- Classification Management per MDR (Class I, IIa, IIb, III)
- Complete Technical Documentation (Spanish)
- Clinical Evaluation Report (CER)
- Quality Management System (EN ISO 13485:2016)
- Post-Market Surveillance Plan (PMS)
- Vigilance System Documentation
- European Authorized Representative (EC Rep)
- UDI-DI Code Registration
- Spanish Labeling and Instructions
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Notified Body Assessment
- Conformity Assessment Completion
- EUDAMED Registration
- Market Access Completion
Registration Timeline
12-24 months
Official Fees
€4,000 - €70,000
Service Fees
$22,000 - $68,000
Regulatory System Overview
AEMPS
Spanish Agency of Medicines and Medical Devices
Responsible for medical device market surveillance, vigilance system management, clinical trial supervision. Operates as the primary medical device regulatory authority under the Spanish Ministry of Health, implementing EU MDR regulations in Spain.
AESAN
Spanish Food Safety and Nutrition Agency
Responsible for food and food supplement safety regulation, risk assessment and nutrition policy development. Ensures safety and compliance of food supply chain.
Consumo
Ministry of Consumer Affairs Spain
Responsible for consumer product market regulation, consumer rights protection, commercial fraud prevention. Conducts strict supervision of product labeling and advertising.
Medical Devices Registration Process
Product Classification Determination
Determine medical device risk classification according to EU MDR 2017/745 (Class I, IIa, IIb, III)
Technical Documentation Preparation
Prepare complete technical documentation including clinical evaluation report, risk management file, performance verification
Notified Body Assessment
Undergo technical documentation review and on-site audit by EU Notified Body
European Authorized Representative
Appoint authorized representative in Spain or EU for regulatory communications
EUDAMED Registration
Complete product and economic operator registration in EUDAMED database
Cosmetics Registration
Regulatory Requirements
- CPNP Notification (Cosmetic Products Notification Portal)
- Product Information File (PIF) Spanish Version
- Cosmetic Product Safety Report (CPSR)
- Good Manufacturing Practice (GMP) Certification
- Spanish Product Labeling
- Ingredient Safety Data
- Nanomaterial Notification (if applicable)
- CMR Substances Compliance Proof
- Responsible Person in Spain
Main Process
- Safety Assessment Completion
- Product Information File Preparation
- CPNP Notification Submission
- Labeling Compliance Review
- Responsible Person Appointment Completion
Registration Timeline
3-6 months
Official Fees
€0 - €3,500
Service Fees
$6,500 - $17,000
Regulatory System Overview
AEMPS
Spanish Agency of Medicines and Medical Devices
Responsible for medical device market surveillance, vigilance system management, clinical trial supervision. Operates as the primary medical device regulatory authority under the Spanish Ministry of Health, implementing EU MDR regulations in Spain.
AESAN
Spanish Food Safety and Nutrition Agency
Responsible for food and food supplement safety regulation, risk assessment and nutrition policy development. Ensures safety and compliance of food supply chain.
Consumo
Ministry of Consumer Affairs Spain
Responsible for consumer product market regulation, consumer rights protection, commercial fraud prevention. Conducts strict supervision of product labeling and advertising.
Cosmetics Registration Process
Safety Assessment
Complete cosmetic product safety report (CPSR) by qualified safety assessor
PIF Documentation Preparation
Prepare complete product information file including Spanish version
CPNP Notification
Submit product information through EU Cosmetic Products Notification Portal
Responsible Person Appointment
Appoint responsible person in Spain for product compliance
Labeling Compliance Review
Ensure labeling complies with Spain market specific requirements
Food Supplements Registration
Regulatory Requirements
- EU Food Regulation (EC) No 178/2002 Compliance
- Spanish Royal Decree 1487/2009 Compliance
- Nutrition and Health Claims Compliance (EC) No 1924/2006
- Spanish Product Labeling
- Ingredient Specifications and Purity Proof
- Heavy Metals and Contaminants Testing
- Microbiological Test Reports
- Allergen Information Declaration
- Spain Specific Ingredient Restrictions Compliance
Main Process
- Ingredient Compliance Assessment
- Technical Documentation Preparation
- Labeling Review Preparation
- HACCP System Establishment
- AESAN Compliance Preparation
Registration Timeline
4-8 months
Official Fees
€600 - €6,000
Service Fees
$8,000 - $20,000
Regulatory System Overview
AEMPS
Spanish Agency of Medicines and Medical Devices
Responsible for medical device market surveillance, vigilance system management, clinical trial supervision. Operates as the primary medical device regulatory authority under the Spanish Ministry of Health, implementing EU MDR regulations in Spain.
AESAN
Spanish Food Safety and Nutrition Agency
Responsible for food and food supplement safety regulation, risk assessment and nutrition policy development. Ensures safety and compliance of food supply chain.
Consumo
Ministry of Consumer Affairs Spain
Responsible for consumer product market regulation, consumer rights protection, commercial fraud prevention. Conducts strict supervision of product labeling and advertising.
Food Supplements Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with Spain and EU permitted lists
Nutrition Claims Review
Review all nutrition and health claims for EU regulation compliance
Labeling Compliance Review
Ensure labeling fully complies with Spanish Royal Decree 1487/2009 requirements
HACCP System
Establish Hazard Analysis and Critical Control Points system
AESAN Compliance
Prepare for inspections by Spanish Food Safety and Nutrition Agency