Taiwan has a highly developed and well-structured product compliance framework focused on consumer safety, public health, telecommunications regulation, and environmental protection. While Taiwan is not part of the EU, its regulations often align with international standards such as ISO, IEC, Codex Alimentarius, and in some sectors, EU CE and US FCC standards. Taiwan enforces its own mandatory BSMI, NCC, and TFDA certifications depending on product categories.

Key Authorities:

• Bureau of Standards, Metrology, and Inspection (BSMI) – Manages product safety standards, conformity assessment, and mandatory certification schemes.

• Taiwan Food and Drug Administration (TFDA) – Regulates pharmaceuticals, medical devices, cosmetics, and food supplements.

• National Communications Commission (NCC) – Oversees telecom and RF equipment compliance, including type approval and spectrum regulation.

• Taiwan Customs Administration – Verifies import compliance and enforces border control measures.

• Environmental Protection Administration (EPA) – Enforces environmental regulations, including e-waste management and hazardous substances control.

Key Compliance Elements:

• Mandatory Certification (BSMI):

  • Products requiring BSMI Certification include:

    • Electrical and electronic devices

    • Household appliances

    • Toys and automotive products

  • Certification Types:

    • Type Approval Certification

    • Declaration of Conformity (DoC)

    • Registration of Product Certification (RPC)

  • Products must bear the BSMI Mark before import and sale.

• Product Registration (TFDA):

  • Required for:

    • Medicines and vaccines

    • Medical devices (classified into Class I, II, III)

    • Cosmetics and dietary supplements

  • Process involves:

    • Submission through the TFDA online platform

    • Clinical and safety documentation

    • GMP and ISO 13485 certification (for medical devices)

    • Appointment of a Taiwan Responsible Person (TRP) for foreign manufacturers

    • Labeling must include Traditional Chinese, with English allowed as supplementary.

• Telecom Type Approval (NCC):

  • All telecom and RF devices must obtain NCC Type Approval before import or sale.

  • Requires:

    • CE or FCC certificates as supporting documents (if available)

    • Local compliance testing may be required

    • Applications submitted by a local authorized representative

  • Approved devices must display the NCC Approval Label.

• Labeling Requirements:

  • Labels must be in Traditional Chinese, and include:

    • Product name

    • Manufacturer/importer contact details

    • Country of origin

    • Usage instructions and safety warnings

    • Expiry or batch number (for health-related goods)

    • BSMI and NCC certification marks (if applicable)

• Environmental Compliance (EPA):

  • Taiwan enforces strict environmental regulations:

    • RoHS-like restrictions for hazardous substances in electronics

    • E-Waste Management Act for recycling of electrical products and batteries

    • Energy efficiency labeling for appliances

• Import Oversight:

  • Importers must provide:

    • BSMI Certification (if applicable)

    • TFDA registration certificates (for health-related goods)

    • NCC type approval certificate (for telecom equipment)

    • Invoice, packing list, and certificate of origin

    • Customs declaration through Taiwan’s Customs Automated System

• Market Surveillance:

Conducted by BSMI, TFDA, NCC, and Customs. Focus areas include product safety, labeling compliance, and environmental standards. Non-compliant goods may face fines, recalls, or bans from sale.