GLGlossary
Labeling and advertising.
The rules that apply to the information written on a product's container, packaging, and instructions, and to the advertising that promotes the product.
There are standards to follow for labeling content and advertising expressions, so we review them together during the preparation stage. The range of permissible expressions can vary depending on the product type and the intended purpose claimed. The appropriateness of specific wording can be confirmed through review.
Related work & timing
Labeling requirements and advertising expressions are reviewed together during the approval preparation stage and adjusted so that they do not conflict with the applicable standards.
Basis
- Medical Devices Act — Articles 20 to 24 (Labeling Requirements and Advertising)View source →
- Enforcement Rule of the Medical Devices Act — Article 45 (Scope of Advertising)View source →
The references shown are for guidance; confirm the exact, current requirements against the source text and through consultation.
The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.