Omologarea

Omologarea is a formal recognition by an authorised authority that a product, process, or service complies with applicable standards, regulations, and safety requirements, enabling its sale, registration, or use within a jurisdiction. The term derives from the French homologation and is widely used in Romania and other Romanian-speaking contexts to describe conformity assessment and market access procedures.

The omologare process varies by country and sector, but typically involves the preparation of technical documentation, testing by accredited laboratories, evaluation of performance and safety, and, in many cases, factory inspections or production audits. Successful evaluation is followed by the issuance of a certificate of conformity or a regulatory decision authorizing market access, with potential ongoing surveillance.

Common domains include automotive (type approval for vehicles and components), pharmaceuticals and medical devices (market authorization and compliance), electrical equipment and construction products, and environmental or safety regimes. The aim is to ensure that products meet defined specifications before they can be sold or used.

Competent authorities, standardization bodies, and notified or accredited laboratories carry out omologarea, depending on the jurisdiction. In practice, it serves as a bridge between technical compliance and legal market access, and may interact with other conformity schemes such as certification marks or CE marking.

See also: homologation, type approval, conformity assessment, certification.