JAPANESE TESTING, STANDARDS, AND CERTIFICATION One of the most important areas of concern for your company is meeting the requirements of Japanese testing, standards, and certification procedures which cover a wide range of product sectors. Unfortunately, obtaining information in these areas from outside of Japan is difficult. Japanese approval procedures are often slow and cumbersome and can be discouraging to those unwilling to make a major commitment of their time and energy. However, significant progress has been made in specific product areas in the last few years, and steps to simplify the system continue. Problems with Japanese standards and certification systems generally have fallen into one of three categories: Lack of Transparency: Some of the committees that draft Japanese standards have shown reluctance to allow foreign participation. As a result, foreign firms whose products could be affected by new standards have had no meaningful input into the development of those standards. Furthermore, in many cases foreign firms do not learn the details of the new standards until after Japanese firms represented on the committees have, and thus the foreign firms lose critical lead time retooling to comply with the new standards. This situation is beginning to improve as more drafting standards committees are opened to participation by qualified foreigners. Lack of Acceptance of Foreign Test Data: In the past, Japanese authorities refused to accept the results of tests conducted by manufacturers or independent U.S. test laboratories. Companies seeking certification had no choice but to submit to testing and inspection by Japanese authorities, exposing certain proprietary information. The Ministry of International Trade and Industry (MITI) now accepts test results from U.S. testing laboratories for certification of electrical appliances. A handful of U.S. labs have received Japanese Government approval to inspect factories and give type approval to U.S. products. MITI has designated the following U.S. testing laboratories to certify products as meeting Japanese safety and quality requirements: DSET Laboratories, Inc. Applied Research Laboratories Box 1850 of Florida, Inc. Black Canyon Stage 1 5371 N.W. 161st Street Phoenix, AZ 85029 Miami, FL 33014 Phone: (602) 465-7356 Phone: (305) 624-4800 ETL Testing Laboratories, Inc. Hazelton Laboratories, Corp. Route 11 9200-T Leesburg Pike Industrial Park Vienna, VA 22180 P.O. Box 2040 Phone: (703) 893-5400 Cortland, NY 13045 Phone: (607) 753-6711 Underwriters Laboratories, Inc. 1285 Walt Whitman Road Melville, NY 11747 Phone: (516) 271-6200 ext. 877 or 614 Underwriters Laboratories (UL) is the only U.S. testing facility that has received MITI designation to conduct product testing for type approval and to approve products under the voluntary Japan Industrial Standards (JIS) system, allowing the product to be marked with a JIS symbol. Progress also has been made in the acceptance of foreign-generated test data for health care products. Japan now accepts the results of all pre-clinical tests conducted outside of Japan, if those tests are conducted according to Japanese test protocols. However, the Ministry of Health and Welfare (MHW) is still reluctant to approve products based on clinical tests performed outside of Japan, even if these tests are conducted on Japanese people. Test data developed in Japan is required for medical implantable or invasive products or devices and pharmaceuticals. Lack of Harmonization with International Standards: Japanese standards often differ from international standards or from standards prevalent elsewhere. While some changes have been implemented, Japanese standards continue to deviate from international standards in many instances. The U.S. Government continues to raise discriminatory standards cases with the Japanese authorities. Japan also has a system of voluntary government and industry marks with specific standards requirements. Japan Industrial Standards (JIS), Japan Agricultural Standards (JAS), and other quality marks are important for winning consumer acceptance for a product and are highly recommended, but can create difficulties for foreign suppliers in those cases where they deviate from international standards. A JIS mark on your product is a quality certification mark in Japan. It means that products with JIS marks satisfy the quality level set by corresponding Japanese Industrial Standards. Although a JIS mark is not mandatory, it is recognized by Japanese consumers as signifying good product quality. JIS mark approval is conducted by the Japanese Government on a factory-by-factory basis. Thus, the quality is indirectly guaranteed by the Japanese Government. Complying with Japanese standards and obtaining import certification can be arduous at times. Your company should work closely with your agent/representative/importer in Japan in order to facilitate this process. Much information on Japanese standards is only available through the appropriate Japanese governmental ministry and/or only exists in written form in the Japanese language. Therefore, it is often up to your representative in Japan to supply your firm with this type of information. Your agent/representative/distributor should carefully study the products to be imported and all regulations concerned. All relevant information should be passed onto your company since goods not conforming to regulations will not be certified to enter Japan. Furthermore, there are cases where a product is controlled by more than one law, or different laws apply to products of the same group, since each law has its legislative objective. Technical regulations are concerned not only with technical specifications of a product itself but also with packaging, marking or labeling requirements, testing, transportation and storage, installation, etc. Your company needs to identify certification requirements for your product if appropriate. Some Japanese standards and certification information is available in the United States and is in English. To determine whether or not Japanese standards on your product exist in the United States, please contact the following organization: U.S. Department of Commerce National Center for Standards and Certification Information National Institute of Standards and Technology Administrative Building, Room A629 Gaithersburg, MD 20899 Phone: (301) 975-4040 The National Center for Standards and Certification Information (NCSCI) provides information on U.S., foreign, and international voluntary standards; government regulations; and rules of certification for nonagricultural products. The NCSCI serves as a referral service and focal point in the United States for information about standards and standards-related information. It responds to requests for information by identifying relevant standards and/or regulations. Searches are made with the aid of various indexes, by contacting professional and standards-developing organizations, and through communicating directly with foreign standards bodies. The requester is referred to the appropriate standards-developing organization for additional (technical) information and/or copies of the document in question. NCSCI does not provide copies of standards. The following is one private sector organization in the United States that has English translations of many Japanese standards for purchase: The American National Standards Institute 11 West 42nd Street, 13th Floor New York, NY 10036 Phone: (212) 642-4900 Your product must be adapted to metric standards. The Office of Metric Programs of the U.S. Department of Commerce provides exporters with guidance and assistance on foreign metric import regulations and on matters relating to U.S. transition to the metric system. It can also give referrals to state metric contacts. For information, call (202) 377-3754. Another source of information on various Japanese standards and regulations is the publication Standards and Certification Systems in Japan -- Measures for Improving Market Access, which is produced by the Japanese Intra-Governmental Council on Standards and Certification Systems (Printing Bureau, Ministry of Finance). This publication is available in the United States from: OCS America, Inc. 5 East 44th Street New York, NY 10017 Phone: (212) 599-4502 The Japan Standards Association (JSA) has established Kikaku Net, an on-line database which was put into operation in October 1989. The system includes two comprehensive files, one for domestic and one for international/overseas standards which have cross reference fields for each other. Many of the fields are supported both in Japanese and English so retrieval is possible in both languages. This system is a convenient tool for your business in identifying existing Japanese standards and the over 200 Japanese manufacturer's associations responsible for drafting specific industry standards. Inquiries on Kikaku Net should be directed to: Overseas Standards Center Japan Standards Association 4-1-24 Akasaka Minato-ku, Tokyo 107 Japan Phone: 011-81-3-3583-8001 (ext. 245) Fax: 011-81-3-3584-5159 Questions on access to Kikaku Net should be directed to: Customer Service Manager Database Business Department Japan Information Processing Service Co., Ltd. 2-4-24 Toyo, Koto-ku, Tokyo 135 Japan Phone: 011-81-3-35690-3202 The Building Center of Japan is a Japanese quasi-government organization which deals with Japanese construction standard issues. If your firm wishes clarification regarding Japanese construction standards, contact: The Building Center of Japan 3-2-2 Toranomon Minato-ku, Tokyo 105 Japan Phone: 011-81-3-3434-7155 (International Section) Fax: 011-81-3-3431-3302 The following two organizations have been designated the General Agreement on Tariffs and Trade (GATT) national inquiry points in Japan for standards information: Standards Information Service First International Organizations Division Economic Affairs Bureau Ministry of Foreign Affairs 2-2-1 Kasumigaseki, Chiyoda-ku, Tokyo 100 Japan The Standards Information Service at the Ministry of Foreign Affairs mainly handles inquiries in the fields of drugs, cosmetics, medical devices, foodstuffs, food additives, telecommunications facilities, motor vehicles, ships, aircraft, and railway equipment. It does not answer inquiries concerning Japanese Industrial Standards (JIS) which are handled by the Japan External Trade Organization (JETRO). Standards Information Service Information Service Department Japan External Trade Organization 2-2-5 Toranomon, Minato-ku 107 Tokyo, Japan The Standards Information Service at the Japan External Trade Organization mainly handles inquiries in the fields of electric equipment, gas appliances, measurement scales, foodstuffs, food additives, etc. Those inquiries concerning JIS on medical devices, motor vehicles, ships, aircraft, and railway equipment are also handled by JETRO.