Product Compliance in Taiwan

The Bureau of Standards, Metrology and Inspection (BSMI) operating under the Taiwanese Ministry of Economic Affairs (MOEA) is the public body in charge of national standardization and product conformity assessment in Taiwan.  On one hand, it develops and publishes the so-called National Standards of the Republic of China (CNS).  On the other hand, it runs the Taiwanese conformity assessment scheme and adopts commodity inspection measures in accordance with the Commodity Inspection Act.

The CNS standards are mostly based on those developed by international standardization organizations such as the International Standards Organization (ISO), the International Electro-technical Commission (IEC), and the International Telecommunications Union (ITU).

Taiwan is also a member of the WTO and its standards must comply with the WTO Agreement on Technical Barriers to Trade (TBT).

The BSMI certification is a product conformity assessment and certification system established already in 1951 to promote the use of local CNS standards and regulations.  Its main legal basis is the Commodity Inspection Act.

The BSMI oversees testing and inspection methods for different product categories.  Product groups or product aspects in scope are: electromagnetic compatibility (EMC), chemistry, polymers, and materials, electrical and mechanical engineering.  In total, over 1000 industrial products mentioned in the Chinese Commercial Code (CCC) are subject to inspection. Testing of commodities can only be carried out by the BSMI itself or by testing laboratories recognized by it.

For example, in terms of the EMC, the BSMI published the “Regulations Governing Electromagnetic Compatibility of Commodities” to meet international requirements for electromagnetic compatibility (EMC) and better protect consumers from different type of risk posed by telecommunications, electrical, and electronics products.  Currently, over 250 products are subject to the EMC inspection.

Products covered by the BSMI conformity assessment must meet the inspection requirements before their shipment to Taiwan.  Therefore, local manufacturers or importers of these products should launch their certification process before they are shipped or imported.  Manufacturers or importers can choose between three inspection approaches:

• Registration of Product Certification (RPC) scheme
• Batch-by-Batch Inspection (BBI) with Type Approval
• Declaration of Conformity (DOC)

The Registration of Product Certification covers both product design and quality management system requirements.  This means that in order to pass the certification process, not only the product itself but also the manufacturing process must comply with the BSMI requirements.  Thanks to the RPC certificate, manufacturers are allowed to place their product on the market and importers may obtain a customs clearance.

The batch-by-batch inspection is quite complicated and time-consuming and it involves testing of every batch of imported products.  However, importers or companies selling products in the domestic market at low volumes may find the BBI with Type Approval approach easier.

The Declaration of Conformity (DoC) is the least restrictive conformity assessment procedure.  It is currently applied only to low-risk products with stable manufacturing technology and few concerns of risk or danger.  Under the DoC, manufacturers may have testing done by BSMI-designated laboratories, prepare their own technical documents, and draft the DoC form themselves. Only few product categories are covered by the DoC system. These are mostly products belonging to the ICT devices such as: digital cameras and video cameras, typewriters, cash registers, electronic calculators, card-punching machines, optical disc devices, data storage units but also vulcanized rubber tubes.

Products specified by the Ministry of Economic Affairs (MOEA) must comply with inspection requirements before they are shipped to Taiwan.  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.

According to the Taiwanese law, only a domestic manufacturer or a person who entrusts others to manufacture the products can submit the application for the BSMI conformity assessment.  For imported products the applicant may be a sales representative or an importer with place of residence or business located in Taiwan.

The product certificate is valid for three years but one time can be extended for an additional three years. To prolong the certificate after the extension a new application is needed. To maintain the validity of the certificate an annual fee has to be paid.

In July 2013 BSMI published (CNS 15663) Guidance on the reduction of the restricted chemical substances in electrical and electronic equipment (EEE) which is the base for Taiwan’s RoHS implementation. The RoHS has MCV’s compatible with European Union’s (EU) RoHS, but it does not cover phthalates (included in EU regulations). The maximum concentration values (MCV) has been established for six dangerous substances found in nine types of EEE: Lead (Pb), Mercury (Hg), Cadmium (Cd), Hexavalent Chromium (Cr6+), Polybrominated Biphenyls (PBB) and Polybrominated Diphenyl Ethers (PBDE).

According to RoHS standard, suppliers of EEE have to use CNS 15050 or IEC 62321 methods to check for those hazardous substances. Moreover, the proper labeling on the product, packaging, stickers, and/or the manuals for the product is demanding.

The RoHS is an additional product inspections standard set by the BSMI for EEE importers which completes safety regulations, electromagnetic compatibility and related tests.

The RoHS requirements for listed products are included into the BSMI certification process which demands that restricted dangerous substances in the product are determined. The enterprise has to fulfill certain requirements like for example:

• Carry out conformity assessment (by Registration of Product Certification (RPC) Scheme or Type-approved Batch Inspection (TABI) Scheme)
• Define the amount of hazardous substance (according to test method CNS 15050 or IEC 62321)
• Apply the Commodity Inspection Mark and RoHS label in packages

Taiwan established the National Communications Commission (NCC) which is mainly responsible for frequency management, radio wave detection, network domain names and websites, and also related international exchange and cooperation. NCC certification is needed for the circulation and use of communications and information equipment in Taiwan.

The NCC radio type approval is based on the following rules:

• Testing process is performed only by a NCC approved laboratory.
• NCC approved CB issues type approval certificate.
• The NCC Certification Mark should be placed on the product after approval.
• Where applicable EMC compliance might be also required.

Taiwanese regulations require a local representative for the NCC certification.

Test reports prepared by foreign laboratories are not accepted since the majority of the NCC-approved test laboratories are in-country (unless there are recognition agreements in place).

The NCC label should be affixed or printed in the proper position of the equipment body with an appropriate ratio and the principle of clarity (there are no maximum or minimum size requirements).

NCC Certification Mark should be attached to the product together with the inspection qualification number followed the regulations.