Navigating Japan’s Cosmetics Registration: A Comprehensive Regulatory Overview

Regulatory Overview

In the “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices” (2023 revision) implemented in Japan since 1960 by the Cabinet Office, Chapter 4 Production and Sales of Pharmaceuticals, Quasi-drugs, and Cosmetics and Chapter 13 stipulates that Japanese manufacturers or distributors intending to import and sell cosmetics manufactured or sold outside Japan must obtain a cosmetic manufacturing license for foreign manufacturers (Article 13-3 of the Act). Foreign manufacturers are required to submit relevant applications to the Pharmaceutical and Medical Device Agency (PMDA) of Japan, before exporting to Japan.

The definitions of foreign cosmetics production distributor and foreign cosmetics manufacturer in Japan are as follows:

Foreign cosmetic production distributors refer to companies registered outside Japan that engage in the production and sale of cosmetics outside Japan and distribute them to end customers.
Foreign cosmetic manufacturers refer to companies registered outside Japan that engage in the production and sale of cosmetics outside Japan.

Manufacturer/Distributor Registration (For Cosmetic Enterprises)

Prior to exporting cosmetics to Japan, in accordance with Japanese regulations, assistance is provided to companies in completing the registration process for foreign cosmetic manufacturers/distributors and obtaining the registration license.

Service Process

Initial consultation, gather relevant company information and translate it into Japanese.
Submit the application to the independent corporation, the Pharmaceutical and Medical Device Agency (PMDA) of Japan, either by mail or in person.
The application process is expected to be completed within approximately 7 days, provided that all necessary documents are provided.

Required Application Documents

Applicant information (company name, contact person, address, phone number, etc.).
Foreign manufacturer information (country, company name, address, phone number, etc.).
List of products for the intended sales (matching the products on the production and sales notification).
If the foreign manufacturer does not designate an applicant, REACH24H can act as the applicant for the foreign manufacturer.

Manufacturing and Sales License (For Cosmetic Products)

Service Process

Initial consultation, gather relevant company information and translate it into Japanese.

Obtain basic information about the product such as raw material information, etc., and evaluate its compliance.
Submit the application to the independent corporation, the Pharmaceutical and Medical Device Agency (PMDA) of Japan, either by mail or in person.
The application process is expected to be completed within approximately 7 days, provided that all necessary documents are provided.

Required Application Documents

Applicant information (company name, contact person, address, phone number, etc.).
Foreign manufacturer information (country, company name, address, phone number, etc.).
Basic product information (including the import cosmetic product’s name, formula, manufacturing methods, dosage and usage instructions, indications and effects, storage method and expiration date, specifications and inspection methods and any other necessary details.)
Make Japanese labels.

Why Choose REACH24H?

Extensive Expertise: Our team of technical and legal professionals in Japan brings years of experience and industry qualifications to ensure your compliance with Japanese beauty industry standards.
Strong Collaborations: Benefit from our vast network and partnerships with key organizations like the Japan Cosmetic Industry Association, Japan Association for Nail and Skin Care, and Japanese testing institutions.
Regulatory Information Platform: Access our independent platform for real-time regulatory tracking, in-depth analysis, and reliable database support, keeping you up-to-date with the latest requirements.
Trusted by Global Brands: We have successfully served over 1000 cosmetic companies worldwide, including renowned Fortune Global 500 companies.
Global Reach: With our global branches and multilingual capabilities, we provide efficient international services, ensuring effective communication and support throughout the process.