How to Start Your Import Business in Japan: Regulations Overview
Wondering how to start your import business in Japan? Before you invest in inventory for your import business, your first step is to find out Japan's regulations governing the goods you wish to sell.
The first thing to know is this: Depending on the product category, there may be import applications, procedures, and other matters to deal with before listing your items for sale in Japan.
Here are 5 categories of regulated goods and what to know about them before starting your import business.
1. Radio-wave emitting products
Mobile phones, Bluetooth devices, Wi-Fi devices, and any item you wish to sell that emits radio waves must meet Japanese radio wave standards and have a designated mark that indicates it complies with Japan's import regulations concerning this category. Products in this category also include the following:
IH cooking devices
To learn about the Radio Act of 1950, go here for the English translation of this Japanese law. For details on the application process and how to get an imported product approved and a mark affixed to your imported goods, the Japan Quality Assurance (JQA) site has a comprehensive English summary of the pathway to approval.
2. Electronic goods and batteries
Whether imported or made in Japan, all electronic goods must display a PSE mark verifying that it has met Japan’s safety standards. Batteries are also included within this category.
If you wish to sell an electronic product, you must submit an official notification to the Ministry of Economy, Trade and Industry (METI) before listing the electrical goods for sale. This applies to goods in the following categories:
Small power transformers
Discharge lamp ballasts
To read the act governing the sale of electronic goods, see this PDF (English) from METI. For a full list of goods that require a PSE mark and how to get a PSE mark for the electric goods you wish to import, JQA’s page (English) on the topic is an excellent resource.
3. Pharmaceuticals and medical devices
This category is a highly regulated one. Importers who wish to sell a medical device or pharmaceutical must first either qualify as a Marketing Authorization Holder or contract with a designated Marketing Authorization Holder to apply to import and sell this category of goods in Japan. The government developed this regulation so that a local company takes on full regulatory and liability responsibility for the product being sold.
To qualify as a Marketing Authorization Holder, you must have an office in Japan and full-time employees who fill the roles of General Manager, Quality Manager, and a Safety Manager, among other stipulations.
In recent years, the government revised the Pharmaceuticals and Medical Device Act to ease import restrictions. However, entry into this market is still complex, and experts suggest you use a designated Marketing Authorization Holder to handle your applications for approving any product in this category you wish to import and sell.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) handles this category of goods’ approval process, under the Ministry of Health, Labour and Welfare’s (MHLW) jurisdiction. The PMDA site is in English here and provides a list of FAQs that give further insight into the application and approval process.
4. Cosmetic products
Cosmetics are also regulated by the PMDA (mentioned above) and must comply with the Pharmaceutical Affairs Act. This applies to products in the following categories:
Perfumes and colognes
Special purpose cosmetics
Steps to approval include a Primary Distributor’s License. Additionally, you will likely need a Cosmetic Manufacturer’s License, required for any product where you—as the primary distributor—engage in the packaging, Japanese labeling, or storing of the imported items. Cosmetic ingredients, labeling, and marketing text must meet a regulated standard to receive importation approval.
If the ingredients in the cosmetic product you wish to import do not violate Japan’s Cosmetics Standards and all the ingredients are indicated on the labeling, the product item’s approval for primary distribution is not required. However, caveats to this and authoritative sources suggest using a Japan-based distributor who can help ensure you are abiding by all regulations as you take your imported goods to market.
The Japan External Trade Organization (JETRO), under the jurisdiction of METI, published a PDF guidebook for importing cosmetics to Japan, available in English here.
5. Food and certain products
This category is regulated by Japan’s Food Sanitation Law, which applies to all imported foods and certain products that are likely to touch a person’s mouth, such as tableware and baby toys. You will be required to submit a Food Import Notification Form to the port’s quarantine station, where your food product cargo is temporarily being stored.
The Ministry of Health, Labour, and Welfare, which handles regulations and inspections, provides this flow chart showing the procedures involved with importing food to Japan.
A summary of guidelines from MHLW on import procedures is available in English here. For a comprehensive explanation of all that you might want to know about importing food to Japan, refer to JETRO’s English Handbook for Imported Foods (PDF).
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This article provided general summaries of the regulations for how to start your import business in Japan. For further detailed information, upfront costs associated with the application process, or research on a category not covered here, ask a TokyoMate Assistant for help!
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