Glossary Term
Labeling Compliance
Definition
Labeling Compliance refers to adherence to regulatory requirements and industry standards for the content, format, and presentation of labels on medical devices, pharmaceuticals, or packaging. This includes ensuring that all information, such as usage instructions, safety warnings, regulatory markings, and identification codes, is accurate, clear, and legible for users, patients, and regulatory authorities.
Relevance to the MedTech Industry
Labeling compliance is essential to ensure safe and effective use of medical devices and pharmaceuticals. It supports regulatory approval, enhances product traceability, and prevents misuse or adverse events due to incorrect or incomplete information.
Additional Information & Related Terms
Related Terms
Unique Device Identification (UDI): A system for marking medical devices with a unique identifier for tracking and traceability.
Regulatory Submissions: Documentation that includes labeling information as part of approval applications.
Post-Market Surveillance: Processes that monitor label effectiveness and compliance after product release.
Label Integrity Testing: Ensures labels remain durable and legible under real-world conditions.
Translation Compliance: Accurate translation of labels into required languages for international markets.