Our International Standards Information Section performs consulting for manual regulations.
We can provide a variety of services to meet your needs upon request, not only in Japan, but in each country and region around the world.
As with the regulations for products, there are international rules for usage instructions and they are determined in the IEC 82079-1 (Preparation of instructions for use) international standard. Each country adapts their own national standards according to their national characteristics after taking into consideration the knowledge level of consumers and social norms. In addition, international standards are revised and changed.
Usage instructions include not just user guides and service manuals, they also include catalogs, carton boxes, product labeling, and all information that explains usage at all stages of the product life cycle from initial purchase to disposal.
Confirm the required laws, bylaws, and regulations applicable to the product, and then extract the related items to be written in the manual.
Propose safety and precaution text based on the results of the product risk analysis.
In order to distribute or use Japanese products in the EU market, the products must comply with the CE marking.
Before products are placed on the market, the CE marking requires that a conformity assessment is carried out according to the directives of the European Commission. Products that satisfy the directives, as well as the packaging, owner's manual, and other related materials, must display the CE marking.
Specifically, the manufacturer must select the directives and standards that apply to the product, and create and translate the related conformity assessments, technical documents, owner's manuals, and service manuals, etc.
Determining which directives are applied to a product is the responsibility of the manufacturer. Which directives are applied is determined by checking the product's intended use, structure, etc. against the scope of each directive. Although there are cases where multiple directives are applied to a single product, only one CE mark is applied to the product.
The authorized representative works on behalf of manufacturers located outside the EU. The representative in the EU serves as the contact point for the CE marking to comply with the market monitoring activities of the applicable competent authorities. Clients who do not have an office located in the EU can use our International Standards Information Section authorized representative service to respond quickly to inquiries from the competent authorities by concluding an authorized representative agreement with our European office.
