Strategic Regulatory Partner for Success in Taiwan

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

Greetings from
Freyr Taiwan

With an extremely diverse business opportunities, Taiwan boasts a beneficial investment scenario for foreign medicine and medical device manufacturers. Taiwan Food and Drug Administration (TFDA) under the guidance of Department of Health (DOH) oversees the regulatory activities in the region. Though the region seems to be lucrative, constantly evolving Regulatory landscape might challenge the manufacturers with region-specific Regulatory obligations.

Freyr as an exclusive global Regulatory partner understands the Taiwan Regulatory environment and assists manufacturers to impeccably carry out compliant Regulatory procedures for successful market authorizations and registrations. Freyr’s Regulatory services in Taiwan span across:

Industries We Serve in Taiwan

Taiwan has a growing demand for Medical Devices. The Taiwan Food & Drug Administration (TFDA) under Ministry of Health and Welfare (MOHW) regulates Medical Devices through Pharmaceutical Affairs Act (PAA). Foreign manufacturers with no physical office in Taiwan require Taiwan agent representation as a pre-requisite for Taiwan Medical Device Registration process.

Freyr Offerings

  • Strategic Regulatory consulting
  • Regulatory Consulting
  • Regulatory Submission: NDA, ANDA, PMF, DMF submissions
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services

Freyr Advantages

  • Strategic local Health Authority contacts – with TFDA
  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines

Looking for Regulatory Support in Taiwan

Contact us now for Expert Guidance and Support