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Taiwan

Capitalise on the market opportunities in Taiwan

TaiwanMost products entering the Taiwanese market must meet the relevant requirements of the authorities depending on the product scope. Product safety requirements and regulations are put in place to reduce risks, improve quality of life and ensure safety during use. 

These regulations and compliance requirements can however pose challenges to companies who are looking to explore new markets in Taiwan. You can ensure that your products successfully meet the Taiwanese standards by working with a market leader, TÜV SÜD. 

TÜV SÜD fully understands the local requirements and procedures applicable in Taiwan. You can rely on our expertise and knowledge to help you access key markets efficiently while at the same time, be assured of our objectivity, integrity and professionalism.

CLICK ON THE RESPECTIVE CATEGORIES BELOW TO GET MARKET ACCESS INFORMATION TO EACH CATEGORY

  • Plug Types

    Type A

    Plug A 

    Type B

    Plug B

  • Electrical Safety

    Regulatory agency

    • Bureau of Standards, Metrology and Inspection (BSMI), Ministry of Economic Affairs (MOEA)

    Regulations

    • The BSMI Safety Mark is mandatory for electrical and electronic products under the Commodity Inspection Act.
    • There are 4 inspection schemes which require compliance with product inspection requirements:
      • Type approval batch inspection (TABI)
      • Monitoring inspection (MI)
      • Registration of product certification (RPC)*
      • DoC
    • The choice of the appropriate conformity assessment procedure depends on the product characteristics as well as other factors.
    • Compliance with Chinese National Standards (CNS).
    • Testing should be done by BSMI or designated test laboratories.
    • EMC compliance is required for the above, where applicable.

    * The RPC scheme is broken down into 7 modules of assessment and requires manufacturers to comply with any one or a combination of these modules. 3C secondary lithium cells/batteries and power banks are mandatory to be included under the RPC scheme from 1 May 2014.

    Guidelines

    • Applicants must be a registered company in Taiwan.
    GENERAL GUIDE
    • TABI – Application with documentation and test reports are submitted to BSMI.
    • MI – A simplified batch-by-batch inspection system.
    • RPC – Application with documentation and test reports are submitted to a designated Certification Body (CB).
    • DoC – Application with DoC are submitted to BSMI; applicant maintains technical file.

    Applicable product categories

    • Audio/video products
    • Home appliances
    • Information Technology Equipment
    • Power tools, etc.

    To determine if a particular product is subject to the above regulations, please contact us.

    Our services at a glance

    • TÜV SÜD is a designated CB able to perform testing and issue Certification of Conformity (CoC) for a wide scope, supporting manufacturers in the applicable BSMI conformity assessment procedures.
       
  • Energy efficiency

    Regulatory agency

    Bureau of Energy (BOE), Ministry of Economic Affairs (MOEA)

    Regulations

    • Minimum Energy Performance Standards (MEPS) and Energy Efficiency Rating Labelling are required for many products.
    • Voluntary government-backed labelling through Energy Conservation Label.

    Guidelines

    • After passing testing for compliance with certain standards, applicants may attach Energy Labels to products.

    Applicable product categories

    • A full list of product categories may be found here. To determine if a particular product is subject to the above regulations, please contact us.

    Our services at a glance

    TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Taiwanese requirements and obtaining the necessary approval. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels.

  • Medical Devices

    Regulatory agency

    • Food and Drug Administration, Ministry of Health and Welfare

    Regulations

    • Since 1 January 2010, the original Bureau of Pharmaceutical Affairs (BPA) has been replaced by the Division of Medical Devices and Cosmetics.
    • The Pharmaceutical Affairs Law (PAL) regulates all medical devices.
    • Most devices need to meet the Good Manufacturing Practice (GMP) requirement based on the ISO 13485.
    • Pre-Market Approval* (PMA) is required for all devices prior to Taiwanese market entry.

    * The DOH is gradually simplifying requirements and actively seeking to harmonise domestic regulations with international practices on pre-market approval of medical devices.

    Guidelines

    • A local representative is required.
    • Companies dealing with medical devices are required to submit the application for GMP and product registration.  
    • Inspection may be conducted on-site or through Quality System Documentation (QSD) review.
    • Device classification is similar to that of US FDA.

    Applicable product categories

    • To determine if a particular product is subject to the above regulations, please contact us 
    • Telecom & Wireless

      Regulatory agency

      • National Communications Commission (NCC)

      Regulations

      • A type approval scheme is to be followed.
      • The NCC Certification Mark should be affixed on the product after approval is granted.
      • Testing must be conducted by a NCC-approved test laboratory.
      • Type approval certificate is issued by a NCC-approved CB.
      • EMC compliance is required for the above, where applicable.
      • From 6 September 2017, those who sell approved Compliance Approval Regulations on Controlled Telecommunications Radio-Frequency Devices (CTRFD) on the internet shall provide approval or a Declaration of Conformity (DoC) label on the webpage.

      Guidelines

      • A local representative is required.
      • Most NCC-approved test laboratories are in-country, thus, test reports generated by foreign test laboratories will not be accepted unless there are recognition agreements in place.

      Applicable product categories

      • To determine if a particular product is subject to the above regulations, please contact us.

      Our services at a glance

      • As a NCC-approved test laboratory, TÜV SÜD is able to perform the required testing to compliance and support manufacturers in obtaining the NCC certification mark.

    EXPLORE

    E-book

    Market access for electrical goods

    Overview of compliance requirements worldwide for electrical and electronic goods.

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