The First Regulatory Check
Before a medical device reaches the market, there is a first regulatory check that determines all subsequent activities. The prior operating license allows companies to manufacture, import, or handle medical devices in Spain and establishes the beginning of their relationship with the health authority. This is not merely a formal permit: it is the tool through which authorities ensure that products meet minimum safety, efficacy, and traceability standards before reaching patients. Holding this license allows companies to demonstrate to regulators that their processes, facilities, and personnel comply with current legal and regulatory requirements.
Scope and Importance
The health product license is far from being just an administrative procedure. It covers activities such as manufacturing, importing, distribution, grouping, and contract manufacturing, with special attention to subcontracted critical processes. It is a living document that must be updated whenever relevant changes occur in the company, from modifications to facilities to adjustments in production processes or organizational structure.
Through this license, the Spanish Agency for Medicines and Health Products (AEMPS) evaluates facilities, processes, equipment, quality systems, and responsible personnel, ensuring that all products are manufactured and managed under controlled and traceable conditions. This guarantees that the products reaching the market are not only compliant with regulations but also safe and effective for their intended use.
Critical Activities Under License
Companies must hold a prior operating license if they carry out the manufacturing of medical devices, sterilization of critical products, importing products into the European market, grouping CE-marked products from different manufacturers, or contract manufacturing of all or part of production processes.
Manufacturing and sterilization are especially critical stages, as any failure could compromise patient safety. Importing, grouping, and subcontracting, while not directly affecting the initial process, involve additional responsibilities that must be clearly controlled and documented before the health authority. Each of these activities requires specific procedures, documentation controls, and traceability systems to maintain a consistent level of safety and quality throughout the product lifecycle.
Safety, Traceability, and Quality
Beyond its mandatory nature, the license ensures patient safety, product traceability, and the existence of an adequate quality system, usually aligned with ISO 13485. It serves as a pillar of trust for patients, healthcare professionals, and authorities and ensures that only companies that comply with regulations can operate responsibly in the market. Ultimately, the license protects both patients and the companies that operate in compliance, reducing legal risks, sanctions, and reputational issues.
A Key Requirement for Operating with Assurance
In such a highly regulated sector, holding a prior operating license is essential. It represents the first step in guaranteeing product compliance and serves as the foundation for the company’s quality assurance, traceability, and patient safety system. Operating without it is not only illegal but also exposes patients to risk and undermines the company’s credibility in the market.
