Taiwan - Standards for TradeTaiwan - Trade Standards
Overview
The Bureau of Standards, Metrology and Inspection (BSMI) under the Ministry of Economic Affairs (MOEA) is the authority responsible for the development, compilation, and publication of the National Standards of the Republic of China (CNS), as well as for conformity assessment. BSMI also implements commodity inspection measures as stipulated in Taiwan’s Commodity Inspection Law.Taiwan’s national standards are based primarily on international standards such as those developed under the International Standards Organization (ISO), the International Electro-technical Commission (IEC), and the International Telecommunications Union (ITU). As a member of the WTO, Taiwan’s national standards also comply with the Agreement on Technical Barriers to Trade (TBT) and other WTO agreements.
BSMI has imposed 13,273 national standards under 26 categories. Of these standards, 3,942 correspond to international standards and 3,902 have been completely harmonized with international standards as of 2018. Under the CNS Market Certification System, complying products may carry the CNS seal of approval.
Taiwan’s sanitary and phytosanitary (SPS) standards, administered by the Taiwan Food and Drug Administration (TFDA) in conjunction with the Bureau of Animal and Plant Health Inspection and Quarantine (BAPHIQ), are generally different from United States standards or those established by international regulatory bodies such as the Office of International Epizootic (OIE) or the Codex Alimentarius. In some cases, these differences – especially the absence of maximum residue level (MRL) standards for many agricultural chemicals in common use internationally – have resulted in market disruptions and created trade uncertainty.
Standards
The Standards Division (First Division) of the BSMI is responsible for general standardization activities including the drafting of regulations, guidance, harmonization planning, administration of the CNS mark, compilation of the standards gazette, and promotion of national standards. The remaining three divisions each oversee standards in specific industry sectors. BSMI issues plans for standards development semi-annually. Updates are published in the standards gazette and notified to the WTO as required under the Agreement on Technical Barriers to Trade.Also under BSMI are the National Standards Review Council, the Information and Communication National Standards Promotion Committee, the National Standards Technology Committees, and the Electronic Information Exchange Committee, all of which work to jointly oversee the development and implementation of CNS.
BSMI has established an online system for the public to obtain CNS Information. The website also provides access to updated standards gazettes.
Testing, Inspection and Certification
The Sixth Division of the BSMI oversees testing and inspection methods. This division currently conducts product testing including electromagnetic compatibility (EMC); biochemistry; chemistry, polymers, and materials; electrical engineering; and mechanical engineering. All 1,065 goods under the Chinese Commercial Code (CCC), including industrial, chemical, mechanical, and electronics products, and more than 1,800 agricultural, food, and fishery products, are subject to inspection. Testing of commodities can only be done by the BSMI or by testing laboratories recognized by the BSMI.Taiwan’s testing system is called the “Registration of Product Certification” (RPC). Under the RPC system, products are subject to conformity assessments that inspect both the design and production phases of product manufacturing. The Declaration of Conformity (DoC) is a least-trade-restrictive conformity assessment procedure that is currently applied only to low-risk products with stable manufacturing technology and few concerns of risk or danger. Under the Declaration of Conformity scheme, manufacturers may have testing done by BSMI-designated laboratories, prepare their own technical documents, and draft the DoC form themselves. As of April 2017, a total of 48 product categories are covered by the DoC system. These products include digital cameras and video cameras, typewriters, cash registers, electronic calculators, card-punching machines, optical disc devices, data storage units, class B main boards of computers, add-on cards with I/O devices, and vulcanized rubber tubes. A complete list of national testing organizations or conformity assessment bodies is available on BSMI’s website.
Products specified by the Ministry of Economic Affairs (MOEA) must comply with inspection requirements before they are shipped from the manufacturing premises or imported and placed on the market. Manufacturers or importers of these products must apply to BSMI for inspection before shipment or importation. BSMI has a dual-track approach to allow manufacturers or importers to choose the “Registration of Product Certification” (RPC) scheme or a Batch-by-Batch Inspection (BBI) with Type Approval.
The RPC scheme encompasses requirements for the product design stage (type testing) and manufacturing stage (quality management system). In other words, while applying for the RPC both the product design and manufacturing processes must still conform to the requirements specified by BSMI. With the RPC certificate, domestic manufacturers may ship their products, and importers may proceed directly with customs clearance.
Importers or firms selling products in the domestic market at low volumes may find the BBI with Type Approval approach easier. According to BSMI, upon approval of the sample product the random inspection rate is about 10 percent. Taiwan’s safety regulations follow International Electrotechnical Commission (IEC) and CNS standards. All safety testing for end products must be done in Taiwan by Taiwan accredited laboratories. The Underwriters Laboratories (UL) safety certification alone is not considered sufficient to meet Taiwan requirements for end product safety certification. Home appliances, certain fire-fighting products, electrical power distribution devices (including cables and switches), lighting products for indoor use, and motors all require safety testing or inspection in Taiwan.
To enhance consumer protection from hazards posed by telecommunications, electrical, and electronics products, and to meet international requirements for electromagnetic compatibility (EMC), BSMI has promulgated “Regulations Governing Electromagnetic Compatibility of Commodities.” Manufacturers or importers must obtain Type Approval of their products from BSMI and all products must submit applications for inspection based on the EMC Type Approval certificate. Currently 253 products are subject to EMC inspection, of which 133 are electrical items, and 120 are electronic products.
Under the March 1999 “Mutual Recognition Agreement for Equipment subject to Electro-Magnetic Compatibility (EMC) Regulations between Taipei Economic and Cultural Representative Office and American Institute in Taiwan,” NIST may designate testing laboratories in accordance with the general provisions and Appendix A of the Asia Pacific Economic Cooperation Telecom Mutual Recognition Agreement for recognition as Conformity Assessment Bodies (CABs) with respect to the EMC regulations of the BSMI. In accordance with the terms of this MRA, BSMI accepts EMC testing by any laboratory located in the United States and accredited by the National Institute of Standards and Technology (NIST) under the National Voluntary Laboratory Accreditation Program (NAVLAP). NIST-accredited labs outside the U.S. are not accepted by BSMI. As of September 2019, BSMI recognizes 171 EMC testing laboratories in the United States Still, except for EMC testing, all other kinds of testing required by BSMI must be conducted in Taiwan.
The Taiwan Accreditation Foundation (TAF) is Taiwan’s sole body authorized to issue accreditation of conformity assessment against international standards. Under the TAF, the Department of Certification Body Accreditation is responsible for executing and managing the assessment and accreditation of domestic certification bodies for quality, product, and personnel management. The Department of Laboratory Accreditation executes and manages the assessment and accreditation of laboratory inspection bodies and proficiency test providers.
Laboratory accreditation is conducted on a voluntary basis. At present, TAF provides laboratory accreditation in four major categories – calibration, testing, civil engineering, and media – with a total of 32 fields. So far, TAF has accredited over 1,931 laboratories in Taiwan. There are about 47 accredited bodies under TAF engaged in the accreditation of management systems which include quality, environmental, occupational health and safety, information security, food safety, and green product management systems – and about 39 for accreditation for commodities.
Detailed information about accreditation in Taiwan and a list of accreditation bodies are available on The Taiwan Accreditation Foundation (TAF) website.
Publication of Technical Regulations
Before publication, proposed and final technical regulations are submitted to the MOEA by the BSMI. This information is then published in the National Standards Gazette. In addition to the Gazette, BSMI also publishes several pamphlets, including the Catalogue of National Standards Categories, the List of CNS Mark Product Items and Directory of CNS Mark Companies, the Compilation of Laws and Regulations for Applying for CNS Mark, the Q&A on Standards and the CNS Mark, and the Q&A on Technical Barriers to Trade. BSMI’s website also provides updated information from standards gazettes and on standards regulations.United States entities can comment on local technical regulations or related issues by contacting the BSMI directly or through the National Enquiry Point for TBT-related issues.
Contact Information
For more information about standards related issues, please contact the following relevant organizations:Bureau of Standards, Metrology, and Inspection (BSMI)
No. 4, Sec. 1, Jinan Rd., Taipei 100, Taiwan
Tel: 886-2-2343-1700
Fax: 886-2-2356-0998
Ministry of Economic Affairs (MOEA)
No. 15, Fuzhou St., Taipei 10015, Taiwan
Tel: 886-2-2321-2200
Fax: 886-2-2391-9973
Members of the World Trade Organization (WTO) are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to notify to the WTO proposed technical regulations and conformity assessment procedures that could affect trade. Notify U.S. (www.nist.gov/notifyus) is a free, web-based e-mail registration service that captures and makes available for review and comment key information on draft regulations and conformity assessment procedures. Users receive customized e-mail alerts when new notifications are added by selected country or countries and industry sector(s) of interest and can also request full texts of regulations. This service and its associated web site are managed and operated by the USA WTO TBT Inquiry Point housed within the National Institute of Standards and Technology, part of the U.S. Department of Commerce.
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