Overview of the Spanish Agency for Medicines and Health Products (AEMPS) and its Role in Medical Devices
Learn about AEMPS, the Spanish regulatory body responsible for medical device safety, classification, and market surveillance under EU MDR.
Overview
Summary of this regulator or jurisdiction and how it relates to market access.
Overview of AEMPS
The Spanish Agency for Medicines and Health Products (AEMPS) is the national competent authority in Spain responsible for the quality, safety, and efficacy of medical devices and medicines.
Medical Device Definition
In Spain, a medical device is any instrument, apparatus, software, or material intended by its manufacturer for medical purposes such as diagnosis, prevention, monitoring, or treatment of diseases or injuries.
Classification
Medical devices are classified into four risk categories according to EU Regulation 2017/745 (MDR):
- Class I: Low risk (e.g., wheelchairs, surgical retractors).
- Class IIa: Medium-low risk (e.g., hearing aids, digital thermometers).
- Class IIb: Medium-high risk (e.g., condoms, TENS units).
- Class III: High risk (e.g., breast implants, cardiac valves).
Marketing Requirements
Products must have the CE Marking to be sold in Spain. AEMPS does not grant individual marketing authorizations for medical devices; instead, it ensures compliance through market surveillance.
Main Roles of AEMPS
- Clinical Investigations: Authorizing and monitoring clinical trials.
- Market Surveillance: Conducting control campaigns and site inspections.
- Vigilance: Managing the "NotificaPS" system for incident reporting.
- Registries: Maintaining national databases of medical devices.
- Certificates: Issuing Free Sale Certificates for export.
Articles & guides
Insight articles mapped to this region on ElendiLabs.
January 21, 2026
Commercialization of Medical Devices in Spain – AEMPS Requirements
In Spain, commercialization of medical devices requires full compliance with EU MDR/IVDR, including CE marking, EUDAMED registration, Spanish national registration for certain devices, proper labelling in Spanish where required, and ongoing vigilance obligations to AEMPS for safe market placement and use.
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January 19, 2026
Marketing Authorisation of Medicinal Products in Spain – AEMPS Procedures
AEMPS oversees the marketing authorisation process for medicinal products in Spain, handling national, decentralised, mutual recognition, and centralised procedures to ensure medicines meet strict standards of quality, safety, and efficacy before they can be placed on the market.
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January 19, 2026
Aggregation of Security Codes for Medicines in Spain – AEMPS Guidelines
AEMPS provides technical guidance on the aggregation of unique security codes (DataMatrix) in the pharmaceutical supply chain in Spain, enabling efficient verification of serialized medicines at higher packaging levels while complying with EU FMD requirements, ensuring accurate decommissioning and preventing falsified products from reaching patients.
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January 17, 2026
International Trade Regulations for Medicinal Products in Spain – AEMPS Framework
AEMPS regulates international trade of medicinal products in Spain, covering import, export, parallel distribution, transit, and special regimes to ensure compliance with EU GMP/GDP standards, safety features verification, and traceability while facilitating legitimate cross-border movement of authorised medicines.
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January 17, 2026
Foreign Trade of Medicinal Products in Spain – AEMPS Regulatory Framework
AEMPS oversees foreign trade of medicinal products in Spain, regulating imports, exports, parallel distribution, and transit operations to ensure compliance with EU standards, quality requirements, and safety features while facilitating legitimate international movement of authorised medicines.
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January 17, 2026
Customs-Controlled and Supervised Medicinal Product Warehouses in Spain – AEMPS Guidelines
AEMPS regulates warehouses under customs control or supervision in Spain for storage of imported medicinal products awaiting customs clearance or release, ensuring compliance with storage conditions, security, traceability, and Good Distribution Practice (GDP) principles to maintain medicine quality and prevent entry of falsified products.
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January 17, 2026
AEMPS Recommendations on Medicine Labeling Design in Spain
AEMPS provides recommendations to enhance medicine labeling clarity and safety, covering name presentation, strength expression, excipients, Braille, symbols, and alignment with EMA QRD templates and EU guidelines.
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January 16, 2026
Principles for Manufacturing, Importation and Distribution of Active Substances in Spain – AEMPS Overview
AEMPS regulates the manufacturing, importation, and distribution of active substances in Spain under EU GMP standards and national provisions, requiring authorisation, quality system compliance, and traceability to ensure active pharmaceutical ingredients (APIs) meet safety, quality, and efficacy requirements before entering medicinal product production.
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January 16, 2026
Good Clinical Practice Standards in Spain – AEMPS Overview
AEMPS enforces Good Clinical Practice (GCP) requirements in Spain for all clinical trials involving human medicines, aligning with EU Regulation 536/2014 and national legislation to protect trial participants, ensure data integrity, and support reliable evidence for marketing authorisation applications.
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January 16, 2026
AEMPS Procedure for Reporting Labeling Issues Prone to Medication Errors in Spain
AEMPS enables reporting of medicine labeling aspects that may cause medication errors, such as similar names or confusing designs, via email to allow regulatory interventions and prevent incidents.
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January 15, 2026
Medicinal Product Naming Structure in Spain – AEMPS Requirements
AEMPS defines the mandatory structure for names of authorised human medicines in Spain, requiring the inclusion of the international non-proprietary name (or Spanish equivalent), strength, pharmaceutical form, and other essential elements, while strictly regulating invented names to prevent confusion, ensure traceability, and support safe use.
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January 14, 2026
Notification of Suspected Falsified Medicines in Spain – AEMPS Procedure
AEMPS requires immediate notification of any suspicion of falsified human medicines through its dedicated channel, including detailed circumstances and product information, to enable rapid investigation, risk assessment, and protective measures such as recalls or market withdrawal while coordinating with national and EU authorities.
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January 13, 2026
Manufacturing of Medicines in Spain – AEMPS Regulatory Oversight
AEMPS regulates all aspects of medicinal product manufacturing in Spain through authorisation of facilities, enforcement of Good Manufacturing Practice (GMP), inspections, certification, and compliance with EU GMP guidelines to ensure quality, safety, and efficacy of medicines placed on the market.
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January 12, 2026
Instructions for Reporting Suspected Illicit Traffic of Medicinal Products – AEMPS Guidance
AEMPS provides detailed instructions to authorised pharmaceutical distributors in Spain on how to identify, document, and promptly report suspected cases of illicit trafficking, diversion, or falsified medicines to safeguard the legitimate supply chain and support enforcement against pharmaceutical crime.
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January 12, 2026
Good Distribution Practice for Medicinal Products in the EU – Spanish Implementation by AEMPS
AEMPS enforces EU Good Distribution Practice (GDP) guidelines in Spain for wholesale distributors of human medicines, requiring authorisation, robust quality systems, temperature-controlled storage, qualified personnel, and full traceability to prevent falsified medicines and ensure product quality throughout the supply chain.
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January 12, 2026
Q&A on Human Pharmacovigilance Legislation in Spain – AEMPS Summary
AEMPS provides a comprehensive Q&A document clarifying key obligations under Spanish and EU pharmacovigilance legislation for marketing authorisation holders, including adverse reaction reporting timelines, risk management plans, periodic safety updates, signal detection, and responsibilities of the Qualified Person for Pharmacovigilance.
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January 12, 2026
Good Laboratory Practice for Non-Clinical Studies in Spain – AEMPS Framework
AEMPS oversees Good Laboratory Practice (GLP) compliance in Spain for non-clinical safety studies supporting marketing authorisation applications of human and veterinary medicines, ensuring data reliability, reproducibility, and international acceptance through inspections, certification of test facilities, and alignment with OECD principles.
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January 12, 2026
Regulation of Medical Devices in Spain by AEMPS
AEMPS regulates medical devices in Spain under EU harmonised legislation, ensuring safety, performance, and market access through conformity assessment, CE marking, registration, vigilance, and market surveillance activities for all classes of devices.
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January 11, 2026
Structure of Medicinal Product Names in Spain – AEMPS Guidelines
AEMPS establishes clear rules for the composition and structure of medicinal product names in Spain to ensure clarity, prevent confusion, facilitate identification, and comply with EU requirements, distinguishing between invented names, common international nonproprietary names (INN), and mandatory elements.
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January 11, 2026
AEMPS Guidance on Excipients in Medicines in Spain
AEMPS outlines requirements for declaring excipients in medicines based on EU guidelines, specifying mandatory excipients with recognized effects, warning statements in leaflets and labeling, and thresholds for quantitative declaration to ensure patient safety.
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January 11, 2026
Clinical Investigation of Medical Devices in Spain – AEMPS Oversight
AEMPS oversees clinical investigations of medical devices in Spain under EU MDR 2017/745, requiring prior authorisation for higher-risk devices, ensuring ethical conduct, participant safety, and compliance with good clinical practice throughout the trial process.
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January 10, 2026
Recommendations for Medicinal Product Distributors on Sales Practices – AEMPS Guidelines
AEMPS provides key recommendations to wholesale distributors in Spain to promote ethical, transparent, and compliant sales practices, emphasizing proper customer verification, avoidance of aggressive promotion, documentation of transactions, and prevention of diversion or falsified medicines in the legitimate supply chain.
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January 10, 2026
Register of Medicinal Product Intermediaries in Spain – AEMPS Public List
AEMPS maintains a public register of authorised intermediaries in the medicinal product distribution chain in Spain, listing brokers and other entities that negotiate or arrange transactions without holding stock, to ensure transparency, regulatory compliance, and prevention of falsified medicines in line with EU requirements.
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January 10, 2026
Naming Rules for Human Medicines in Spain – AEMPS Framework
AEMPS sets mandatory rules for naming human medicines in Spain, requiring inclusion of the common international non-proprietary name (or equivalent), pharmaceutical form, strength, and route of administration when necessary, while regulating invented names to avoid confusion and ensure patient safety and correct dispensing.
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January 10, 2026
Implantable Medical Devices Registry in Spain – AEMPS System
AEMPS operates the national registry for implantable medical devices in Spain to ensure long-term traceability, patient safety monitoring, and effective vigilance for high-risk implantable products such as pacemakers, hip prostheses, and breast implants, in compliance with EU MDR requirements.
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January 10, 2026
Spanish Legislation on Medical Devices – Overview by AEMPS
AEMPS provides an overview of the legal framework governing medical devices in Spain, primarily based on EU Regulations 2017/745 (MDR) and 2017/746 (IVDR), supplemented by national laws, royal decrees, and implementing regulations to ensure safety, performance, and market surveillance.
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January 9, 2026
Register of Authorised Pharmaceutical Distribution Entities in Spain – AEMPS Catalogue
AEMPS maintains a public catalogue listing all authorised entities involved in pharmaceutical distribution in Spain, including wholesale distributors, manufacturers with distribution activities, import entities, and customs-supervised warehouses, to promote transparency, facilitate verification of legitimacy, and support regulatory compliance across the supply chain.
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January 9, 2026
Pharmacovigilance Good Practice Inspections in Spain – AEMPS System
AEMPS conducts Good Pharmacovigilance Practice (GVP) inspections in Spain to verify compliance with pharmacovigilance obligations by marketing authorisation holders, ensuring robust systems for adverse reaction detection, assessment, reporting, risk management, and signal detection in line with EU GVP modules and national requirements.
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January 9, 2026
Guide for Pacemaker Patients in Spain – AEMPS Recommendations
AEMPS provides practical guidance for pacemaker patients in Spain, covering daily life precautions, compatible activities, electromagnetic interference risks, medical procedures to avoid or adapt, travel considerations, and when to seek medical help to ensure safe and effective device use.
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January 8, 2026
Donation of Medicinal Products in Spain – AEMPS Regulatory Guidelines
AEMPS establishes specific rules for the donation of medicinal products in Spain, allowing authorised entities to donate unused or near-expiry medicines under strict quality, safety, and traceability conditions to prevent risks to public health while facilitating access in humanitarian or low-resource settings.
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January 8, 2026
Project for Elimination of Paper Package Inserts for Hospital Medicines in Spain
AEMPS launched a project to progressively eliminate paper package inserts for hospital-only human medicines in Spain, replacing them with electronic versions accessible via CIMA and DataMatrix codes, aiming to reduce environmental impact, improve information access, and maintain safety through controlled digital transition.
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January 8, 2026
National Registers of Medical Devices and IVDs in Spain – AEMPS Overview
AEMPS maintains national registers for medical devices and in vitro diagnostic medical devices (IVDs) in Spain, including the Registry of Medical Devices (RPS), to ensure traceability, compliance with EU MDR/IVDR, and effective market surveillance during transitional periods and beyond.
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January 7, 2026
Verification of Legality of Suppliers and Customers in Pharmaceutical Distribution – AEMPS Guidance
AEMPS requires wholesale distributors in Spain to verify the legitimacy and authorisation status of suppliers and customers before transactions, using the public AEMPS catalogue and other registers, to prevent falsified medicines from entering the legitimate supply chain and ensure compliance with EU Falsified Medicines Directive obligations.
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January 7, 2026
Marketing and Placing on the Market of Medical Devices and IVDs in Spain
In Spain, medical devices and in vitro diagnostic medical devices (IVDs) must comply with EU MDR/IVDR requirements for marketing and placing on the market, including CE marking, registration in EUDAMED, Spanish national registration obligations during transitional periods, and vigilance reporting to AEMPS to ensure traceability and safety.
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January 6, 2026
Allergen-Based Medicines in Spain – AEMPS Regulatory Framework
AEMPS regulates allergen-based medicines in Spain as a special category of human medicines used for diagnosis and specific immunotherapy of IgE-mediated allergies, requiring strict compliance with quality, safety, and efficacy standards, including individualised production, batch release, and pharmacovigilance obligations.
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January 6, 2026
AEMPS Guidance on Medicines and Safe Driving in Spain
AEMPS informs about medicines that may impair driving due to side effects like drowsiness or reduced reflexes, requiring warnings in package leaflets and a specific pictogram on packaging for affected medicines.
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January 6, 2026
Export and Free Sale Certificates for Medical Devices Issued by AEMPS in Spain
AEMPS issues Certificates of Export/Free Sale (CERTPS-CLV) to Spanish companies for medical devices, active implantables, and IVDs to facilitate exports to non-EU countries by certifying regulatory compliance, with online applications and specific rules for non-CE marked products.
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January 6, 2026
Breast Implants Regulation and Vigilance in Spain – AEMPS Guidance
AEMPS maintains strict oversight of breast implants in Spain under EU MDR, requiring CE marking, manufacturer vigilance, annual reporting of ruptures and complications, patient registries, and rapid response to safety signals such as BIA-ALCL and other adverse events.
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January 5, 2026
Frequently Asked Questions on Pharmaceutical Laboratories Authorization and Operations by AEMPS in Spain
AEMPS addresses common queries on pharmaceutical laboratory authorization in Spain, covering importation requirements, technical director qualifications, subcontracting limits, and responsibilities under EU and national GMP standards.
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January 5, 2026
Modification Procedure for Pharmaceutical Laboratory Authorizations by AEMPS in Spain
Modifications to authorized pharmaceutical laboratories in Spain require prior AEMPS approval, submitted electronically via LABOFAR, with evaluation potentially including inspections and a resolution timeline of 30 days (extendable to 90 days).
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January 4, 2026
AEMPS Circular 1/2011 on Mandatory Information in Medicine Package Leaflets in Spain
AEMPS Circular 1/2011 requires specific phrases in package leaflets for nationally authorized medicines in Spain, including links to updated information on the AEMPS website and proper medicine disposal instructions.
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January 3, 2026
Pharmaceutical Distribution and Laboratory Authorisations in Spain – AEMPS Requirements
AEMPS regulates pharmaceutical distribution and laboratory activities in Spain, requiring specific authorisations for wholesale distribution, manufacturing laboratories, and control laboratories to ensure traceability, quality, and compliance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) standards across the supply chain.
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January 2, 2026
Authorization Procedure for Pharmaceutical Manufacturing Laboratories by AEMPS in Spain
AEMPS requires prior authorization for pharmaceutical laboratories manufacturing or importing medicines in Spain, including export-only facilities and importers performing control analyses, with applications submitted electronically and involving GMP-compliant facilities, qualified personnel, and inspections.
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November 2, 2025
Commercializing Medical Devices: AEMPS Notification
Commercial success in Spain relies on meeting both the **EU MDR** and specific national requirements set by the **AEMPS**. Key steps include mandatory **AEMPS notification** for all devices, utilizing an **EU Authorized Representative**, and ensuring all documentation is compliant with the **Spanish language** mandate.
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August 21, 2025
Spanish Medical Device Market Entry: AEMPS Registration and Language Mandates
Entering the Spanish market requires **CE Marking compliance**, mandatory national registration with the **AEMPS** (Spanish Agency for Medicines and Medical Devices), and strict adherence to **Spanish-language requirements** for all user and patient documentation. The process involves an **Initial Submission** and a regulatory review period (30–90 days).
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