Japan Import Regulations & Other Laws
Quasi-Drugs under the PMD Act
Quasi-drugs are products regulated under Japan’s PMD Act that have milder effects than pharmaceuticals but are used for certain approved purposes, often seen in medicated cosmetics, oral care, hair care and hygiene products.
Medicinal Claims under the PMD Act
Medicinal claims are expressions that suggest treatment, prevention, improvement of disease or effects on the structure or function of the body, and may create PMD Act risks for foods, supplements, cosmetics and general goods sold in Japan.
Medical Device Marketing Authorization Holder Licence
A Medical Device Marketing Authorization Holder Licence is the PMD Act licence required for the Japan-side party responsible for placing medical devices on the Japanese market.
Medical Devices under the PMD Act
Medical devices imported into Japan may require PMD Act classification, licensing, registration, approval, certification or notification depending on their intended use, risk class and marketing claims.
Cosmetics Import and Marketing Licences in Japan
Cosmetics Import and Marketing Licences in Japan refer to the practical set of PMD Act licences, notifications and responsible-party requirements needed when overseas cosmetic products are imported and sold in Japan.
Cosmetics in Japan
Cosmetics in Japan are products used to clean, beautify, increase attractiveness, alter appearance, or keep the skin or hair in good condition, with mild action on the human body. For import sale, overseas cosmetic products must be checked under the PMD Act, including classification, ingredients, notifications, labelling and advertising claims.
Health Foods and the PMD Act in Japan
Health foods are products consumed for health maintenance, nutrition, beauty or wellness purposes. In Japan, imported health foods may be handled as foods, but their ingredients, labels, advertising claims and sales purpose must also be checked under the PMD Act and other related laws.
In Vitro Diagnostics
In vitro diagnostics are regulated products used to examine specimens taken from the human body, such as blood, urine, tissue or secretions, for diagnosis, testing or measurement. In Japan, importers should check whether the product falls under the PMD Act before sale, distribution or diagnostic use.
Gas Appliances Safety Regulations in Japan
Gas Appliances Safety Regulations in Japan refer to the safety control system for certain city gas appliances, including technical standards, notification, inspection and PSTG mark requirements before domestic sale.