Technical and Document Preparation
Obtaining a prior operating license for medical devices does not start simply by submitting an application. It begins with thorough technical and organizational preparation. The health authority evaluates whether the company has the necessary structure, resources, and systems to ensure product compliance throughout all stages of its lifecycle. This includes internal procedures, process controls, manufacturing records, and storage protocols, all designed to meet regulatory standards and maintain product quality. Proper preparation of documentation and internal processes significantly reduces evaluation time by the AEMPS and prevents issues during inspections.
Quality System and Technical Responsible Person
Having a quality system aligned with ISO, preferably ISO 13485, is essential to structure processes coherently and maintain control. In addition, every company must appoint a Technical Responsible Person, mandatory under Royal Decree 192/2023, who oversees compliance with the quality system, manages product documentation, and serves as the liaison with health authorities. This person can be internal or contracted externally, as long as they meet the legal requirements and dedicate their time exclusively to ensuring product compliance.
Technical File and Post-Market Surveillance
Every medical device must have a complete and updated Technical File, documenting the product’s history and containing detailed information on design, manufacturing, labeling, instructions for use, risk management, and verification and validation activities. In addition, a post-market surveillance system allows companies to monitor product safety and quality throughout its lifecycle, ensuring that any changes or incidents are managed transparently and in compliance with regulations. This ongoing surveillance is particularly important for high-risk or implantable devices.
License Application and Maintenance
Once all requirements are met, the license is requested through the AEMPS IPS application, which allows companies to register their activities, declare responsibilities, and keep information updated for the health authority. The license is granted for a period of five years and requires active maintenance, reflecting any relevant changes in facilities, processes, or activities. Proper management of the license not only ensures regulatory compliance but also guarantees operational continuity, patient confidence, and stability in daily operations.
A Continuous Regulatory Obligation
Obtaining the health product license is not a one-time milestone but the start of a continuous compliance obligation. It requires ongoing documentation updates, process controls, and monitoring of product safety throughout its lifecycle. Proper management ensures that the company operates legally, responsibly, and reliably, strengthening its reputation and meeting the highest standards in the healthcare sector.
