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Life Science Compliance Services in Taiwan

Turn your concept into commercialization with our end-to-end streamlined regulatory services.
Taiwan

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We provide overarching regulatory services across all life science products. Leverage Artixio’s strong regulatory compliance and solution services for smooth transition from product development to registration and market authorization. Partner with us for expedited regulatory approvals.

Regulatory Authorities in Taiwan

The Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare (MoHW) is responsible for the regulation and inspection of health products including pharmaceuticals, medical devices, cosmetics, biologics and food. The regulation of veterinary products is governed by the Animal Health Inspection Division of the Animal and Plant Health Inspection Agency (APIHA) under the Ministry of Agriculture.

Initially it was the Bureau of Pharmaceutical Affairs, the Bureau of Food Safety, the Bureau of Food and Drug Analysis and the Bureau of Controlled Drugs. All these were consolidated on January 1, 2010, into the current TFDA. The goal of both the regulators is to ensure the safe and quality reach of the products to the consumers so as to safeguard the public as well as animal health.

What We Do at Artixio?

Artixio is an ISO 9001:2015 certified company that provides quality and reliable services to our clients. We have region-based experts with 15-35 years of experience in guiding our clients through Pharmaceutical, Medtech, Beauty and Wellness, Food and in Animal health & Welfare sectors. Even Though we are still expanding our network and services across the globe, we have a well-established network in Taiwan. Our local Subject Matter Experts have produced a 95% of success rate for all the projects with their well-versed regulatory knowledge.

Where does our expertise come from?

With major adulteration and problems rising with substandard products, it is required by the health authorities to revise and form stringent laws and guidelines for market entry. Staying abreast of the rapidly evolving regulations is very crucial and Artixio’s expert professionals manage it well. Our expertise comes from uncompromised regulatory compliance, tech assisted regulatory intelligence services, strategized, clear, direct solution structuring, accurately executing the solutions, and regulatory gap assessment. We guide you through product development, product registration, post market entry services and product lifecycle management as well.

Post-registration

Market entry services, Post market Surveillance, Product lifecycle management services, performance evaluation reports, Advertisement and promotional material review, Digital marketing and other ongoing support services.

Services through all phases

Regulatory solutions and strategies, Response to regulatory queries, Market access, Gap assessment, Pharmacovigilance, Quality services.

Registration

Product registration (IND, NDA), Artwork and labeling, Publishing and submission services, Taiwan Agent and TFDA liaison services, testing, TFDA audit support, product approval services, and all other registration associated services.

Pre-registration

Market research, Regulatory intelligence and strategy, Technical due diligence, Product development services, Technical and medical writing and other pre-registration services.

Our Services

Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
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Why Artixio?

Successful approvals and ongoing product lifecycle maintenance for 200+ products.
Diverse products experience across complex products categories and therapeutic areas.
Strong regional expertise, experts with 15-35 years of experience.
Proven experience in end-to-end product value chain from concept to commercialization.
TFDA experience in navigating through complex, often ambiguous regulations.
Intelligence driven, global regulatory services supported by Dvarka.
ISO 9001:2015 quality standards governed services.
Customer focused, flexible services and solutions.
Flexible business model including project based, managed services and FTE staffing model.
Hybrid-Local-Centralized support across all PMDA functions.

Industries We Serve in Taiwan

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

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FAQs

What are some common challenges faced by foreign manufacturers in Taiwan?
TFDA has put in place strict regulatory standards to guarantee the safety and quality of any product reaching the Taiwan market. TFDA demands strict regulatory compliance to these regulations as well which is a challenge. Understanding the local market, language and cultural barrier, navigating through Taiwan specific quality standards, management of the product supply chain and competence with already established brands in Taiwan are some of the other challenges faced by manufacturers in Taiwan.
The Taiwanese government introduced the Refusal to File (RTF) procedure in 2017 to avoid the unnecessary review of dossiers submitted that were incomplete. Since 2017, applications that are not in CTD format, incomplete administrative or technical documents are subjected to Refusal to File decision. The applicants themselves can evaluate their application by the RTF checklists announced by TFDA. Within 14 days after submission, a decision for RTF or non-RTF is made.
Product registration and examination record keeping, audit and certificate issue, manufacturers chain monitoring and correlated training, product of laboratory testing, research and technological development, product of risk assessment and management, product monitoring outbreaks investigation and resolution and promotion of consumer protection are the functions carried out by TFDA.

For an application to undergo priority review process, it must meet any 2 of the following criteria: i) It must be new chemical entity, combination, indication or must have a new administration route, ii) Must meet the unmet medical needs (in the treatment of serious conditions) and should have a significant clinical advance if approved, iii) Addresses an unmet medical need and is under the special national scientific research and development programs.

PIC/S, the Pharmaceutical Inspection Co-operation Scheme is an international official organization which consists of 49 participating authorities in the GMP field of medicinal products from all over the world. It focuses on the developing, implementing and maintaining harmonized GMP standards and quality system of inspectators globally and other international affairs as well. Yes, TFDA is a member of PIC/S.
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