Product Registration in Taiwan for Life Sciences

Entering the Taiwan market? We help with every step of product registration in Taiwan—from preparing your dossier to getting final approval from TFDA.

Services We Offer

Product Registration & Approval in Taiwan

Artixio supports life sciences companies with product registration in Taiwan. We handle all stages from document preparation to submission, ensuring compliance with TFDA regulations. Our team customizes the process for pharmaceutical, medical device, cosmetic, nutrition, biologic, and veterinary products to meet local requirements and facilitate market entry.

Regulatory Authority – TFDA, Taiwan

The Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare (MOHW) is the primary regulatory body responsible for the registration and approval of products in the life sciences sector.

If you are looking for TFDA product registration for life sciences, we help you make sense of the rules and manage your product registration smoothly across all steps.

Product Registration Process in Taiwan

Getting your product approved in Taiwan means working closely with TFDA. We guide you through the registration process, so you can launch without delays.

Product Classification
Appoint Local Agent
Document Preparation
Dossier Submission to TFDA
Review & Clarifications
Local Testing (if applicable)
TFDA Approval
Import License Issuance
Post-Approval Compliance

Why Choose Artixio for Product Registration in Taiwan

15+ regulatory experts dedicated to Taiwan-specific product registrations
4-step tracking system for clear progress visibility at each stage
300+ regulatory questions resolved during consultation for Taiwan-based filings
2x faster turnaround for classification and document gap checks
Local knowledge of TFDA registration practices

FAQs

Is a local representative required for registration in Taiwan?

Yes, foreign companies must appoint a Taiwan-based local agent authorized to liaise with the Taiwan Food and Drug Administration (TFDA).

Do we need to conduct local testing for product approval?

Depending on the product category and classification, local testing or certification from designated labs in Taiwan may be required.

What are the common reasons for registration delays in Taiwan?

Frequent issues include incomplete documentation, incorrect translations, missing certificates (like FSC), and delays in product classification confirmation.

Does Taiwan accept approvals from the US FDA or EU authorities?

While international approvals are beneficial, Taiwan has its own regulatory review process. Existing approvals can sometimes support technical dossier assessments but won’t replace TFDA evaluation.

Can we register multiple products under one application in Taiwan?

No, each product variant or strength generally requires a separate application with full supporting documents.

How often do licenses or registrations need renewal?

Most product registrations in Taiwan are valid for 5 years and must be renewed before expiry to maintain market access.