Although not meant to be all-inclusive, this can give you an introduction to some of the details you need to be aware of for specific markets.

More country-specific information is available from the Trade Information Center's Regional Databases here!

Standards and Documentation

Product Standards

The "voluntary" Japanese Industrial Standards (JIS) mark, administered by Japan's Ministry of Economy, Trade, and Industry (METI) applies to nearly 600 different industrial products, and consists of over 8,500 standards.

The setting of standards in Japan is the responsibility of the Japanese Industrial Standards Committee (JISC), a grouping of national committees, under the Ministry of Economy, Trade and Industry (METI). The various product standards requirements then flow down through various accreditation bodies, some of the principal ones being:

• JASC -- The Japan Accreditation System for Product Certification Bodies of JIS Mark
• IAJapan – International Accreditation Japan
• JAB – Japan Accreditation Board for Conformity Assessment
• AIST – National Institute of Advanced Industrial Science and Technology
• NMIJ – National Measurement Institute of Japan – operates as part of the National Institute of Advanced industrial Science and Technology (AIST).
• The Japan Agricultural Standards (JAS) mark is another "voluntary" but widely-used product quality and labeling mark for agricultural products.

There is a general trend in Japan of aligning its products standards with prevailing international standards.

* Medical Device Regulations

A Japanese company that intends to market a foreign medical device needs to receive a "license for manufacturing/marketing business" (seizo hanbai gyo kyoka). The company holding this license is called a "Marketing Authorization Holder (MAH)." A MAH must be physically located in Japan. The MAH must obtain a marketing approval (hanbai shonin) for each product. To obtain this shonin, the MAH has to guarantee the quality, safety and efficacy of the product, and ensure compliance with other requirements such as GMP (Good Manufacturing Practice) for the manufacturing establishment, the production control system and quality control system. The quality and manufacturing system of the subject product shall be assessed either on-site or through document review. 

The MAH must also comply with GQP (Good Quality Practice), which governs product quality and also GVP (Good Vigilance Practice), which gives guidance on monitoring post-market sales in the markets where the products are being and have been sold, and on taking immediate action to minimize any public health hazards. In short, the MAH is responsible not only for the product but also for all the processes related to quality and safety. In addition, a foreign manufacturer intending to manufacture medical devices in foreign countries and export them to Japan, is required to be accredited by the Minister of Health, Labor, and Welfare (MHLW) as an "Accredited Foreign Manufacturer" in the same way that a Japanese manufacturer is licensed. Typically, a MAH can make an accreditation application on behalf of a foreign manufacturer and a product approval status can be transferred if a MAH agrees to do so.  The MAH is responsible for the products and all the processes related to quality and safety and the MAH can only import products for which they have obtained a marketing approval. Therefore, it is critical that the MAH and manufacturer establish good communications channels with each other.

Shipping Documentation

When shipping U.S.-made products to Japan, the U.S. exporter should include the following documents along with the shipment, and, in some cases, provide them to the importer/buyer.

International Commercial Invoice: An invoice is required when exporting a product sold to a buyer in Japan. Some key information that should be listed on the invoice includes:

• A description of the good(s)
• The monetary value of the good(s)
• The net and gross weight (and unit weight if pertinent)
• Information on the country of manufacture (i.e. country of origin)
• Freight and insurance costs, and any other charges or discounts as individual line items
• A unique invoice number - this must be assigned to each invoice issued

*It is still necessary to check for additional information which might be requested on specific transactions

Certificate of Origin: To ensure that U.S. goods receive the WTO-duty rate upon entry into Japan, a certificate of origin should be provided. The original certificate of origin should be in the possession of the importer at the time of entry as copies are not acceptable. The country of origin of the goods must also be shown on the commercial invoice. 

Air Waybill or Bill of Lading: In general, the shipper/carrier will generate/provide this document. 

Packing lists, freight accounts, insurance certificates: Documents such as these should be provided when deemed necessary. Talk to the importer to determine whether such documents may be needed. 

Additional Information 

Japan's Ministry of Finance maintains a website: www.customs.go.jp/english/index.htm which describes import clearance and customs procedures, and provides contact information and other detailed information in English.