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Cosmetics as defined in Japan (PMDA)

As defined in Japan (PMDA), 'cosmetics' means 'things intended to be applied to the body, sprayed or other similar methods to clean and beautify a person's body, increase attractiveness, change appearance, or protect skin or hair' no see. It means that the action on the human body is alleviated. (Pharmaceuticals Act Article 2, Paragraph 3)

• Items that are considered cosmetics by law

All makeup cosmetics, basic cosmetics, hair tonic, perfume

All toiletries including toothpaste, shampoo, conditioner, soap, and bath products

• Classification of quasi-drugs

All medicated cosmetics that emphasize preventive effects are classified as quasi-drugs, not cosmetics, according to the Pharmaceutical Affairs Act.

Cosmetics export license system to Japan stipulated by Japan (PMDA)

It is classified as cosmetics or quasi-drugs according to the regulations of the Pharmaceutical Affairs Act [Cosmetics Standards].

Only those who have obtained a manufacturing business or manufacturing and sales business license can register and manufacture and sell in Japan.

Flow chart of permission to export cosmetics to Japan as stipulated by Japan (PMDA)

• STEP 1 Analysis of sample components

According to the "Cosmetics Standards" in the Pharmaceutical Affairs Act of Japan, the ingredients of cosmetics are checked. For official export to Japan, you must analyze the ingredients to see if they meet the Japanese domestic cosmetics standards, and prove the test report issued by the Japanese Food Analysis Center. Main items to be checked: formaldehyde, arsenic, lead, cadmium, mercury, general bacteria quantity, mold quantity, methanol

• STEP 2 Administrative agency sales application

classification administrative agency Documents to be submitted
Cosmetics manufacturing and sales application Office location, prefectural governor Original application + 1 copy
Cosmetics (foreign manufacturer / distributor / foreign manufacturer) application Foreign manufacturers and distributors: competent provincial government Foreign manufacturer : PMDA Original application + 2 copys
Application for import of cosmetics for manufacturing and sale Jurisdiction Welfare Bureau (affiliated with the Ministry of Health, Labor and Welfare) Original application + 1 copy

• STEP 3 Import customs clearance

No. process Contents
1 customs import declaration Requires AWB (Air Way Bill), B/L, Invoice, Packing List, etc.
2 customs inspection A copy of the application form for importation of cosmetics for manufacturing and sales must be attached.
3 tax payment - Review the contents of the report and conduct actual inspections as necessary
- When customs duties and import consumption tax are paid, an import permit is issued.
4 Issuance of import permit Issuance of import permit

• STEP 4 Quality Control

GQP quality management work: name of rules stipulated in accordance with quality management standards

Manufacturers and distributors need to prepare quality control standards in accordance with the GQP ordinance, and must manage manufacturing records and test inspection records by conducting inspections on every lot of products. (Only items that pass inspection must be shipped)

GVP safety management task: name of rules stipulated in accordance with safety management standards

In-house regulations must be established from receipt of product adverse effect information to countermeasures, review methods, and final processing. It is necessary to establish and implement countermeasures to minimize the damage caused by adverse effects. The label of the product must be written and attached to the product in accordance with the Pharmaceutical Affairs Act and then sold.
Labeling contents: product name, capacity, ingredient, production number, manufacturer and salesperson, container and packaging labeling method, barcode, etc.

• STEP 5 Product storage and delivery to the designated location

The imported products are stored in the warehouse and delivered to the location designated by the customer.

美国 CERT 可以通过与相关组织合作，提供专业的技术支持，以满足客户在日本（PMDA）医疗器械制造和进口许可方面的需求和法律要求。此外，我坚信，企业通过获得产品制造和进口许可证，将获得成长为全球性公司的动力。