Artixio

Regulatory Affairs Services in Taiwan

Market ready compliance regulatory affairs solutions in Taiwan for product approvals across the pharmaceuticals, MedTech, nutrition, cosmetics, biologics, and veterinary industries.

Register your Product in Taiwan’s Regulated Sectors

Taiwan’s life sciences sector is progressively growing, driven by a public health ecosystem with increasing healthcare investments, enhanced demand for innovative healthcare products, and growing aging population. As of 2025, Taiwan’s pharmaceutical industry is projected to grow by US $4.09 billion market, and is forecasted to reach US $4.92 bn.

The Taiwan Food and Drug Administration (TFDA), under the Ministry of Health and Welfare (MOHW), operates the regulatory framework for pharmaceuticals, medical devices, cosmetics, nutraceuticals, and veterinary products.

Taiwan is a key entry point into the Asia-Pacific market due to its regulatory affairs system following international standards like ICH, PIC/S, and GHTF. Entering this market requires proper documentation, compliance with local requirements, and working closely with a Taiwan-based license holder. A trusted regulatory affairs consultant in Taiwan can guide you through the process and help manage local regulatory needs effectively.

Regulatory Affairs Process In Taiwan

To legally market regulated products in Taiwan, companies must follow a structured approval process. While the process varies by product type, it generally involves the following steps:
regulatory affairs consultant

Step 1 - Product Classification

Classifying a product is necessary to determine the required documentation and regulatory approval pathway. A regulatory affairs consultant or regulatory affairs consulting company can help assess the correct product category and guide you through the appropriate regulatory steps. Examples include:

Step 2 - Appoint a Taiwan Responsible Person (TRP)

A local entity in Taiwan is appointed as Taiwan Responsible Person (TRP) on behalf of overseas manufacturers. The TRP handles submissions, approvals, communication with TFDA, and post-marketing obligations.

Step 3 - Dossier Compilation

The registration dossier must comply with TFDA formats, including:

Step 4 - TFDA Submission and Review

Product submission is done via the TFDA e-Platform. Certain devices and generics may be eligible for priority or simplified review. Review timelines vary depending on the product categories:

Step 5 - Labeling and Packaging Compliance

Step 6 - Product Approval & Post-Market Obligations

The TFDA reviews the application and may request additional information, if required. Once approved, the license holder must:

Core Documents Required for Regulatory Affairs Process In Taiwan

A structured dossier that meets both regulatory and localization standards must be submitted to register a product with the Taiwan Food and Drug Administration (TFDA). The following documents are typically required for product registration and may vary depending on the product category. Partnering with experts offering regulatory affairs consulting services can help ensure all documentation is accurate, complete, and aligned with TFDA expectations.

Documents Preparation Tips

Why Artixio As Your Regulatory Affairs Consultant In Taiwan?

5000+ licenses approved & maintained for international clients in Taiwan
End to End product lifecycle support and renewals
Established TRP partnerships
Trusted by top 10 global healthcare companies
ISO 9001: 2015 Certified company for quality-driven services
Are you launching your product in Taiwan and looking for a seamless, end-to-end regulatory strategic product registration in Taiwan?

Artixio supports end-to-end product registration in Taiwan with local insights, regulatory accuracy, and full-cycle support—helping your products reach the market without delays or compliance risks. We offer expert regulatory affairs and compliance consulting services to guide you through every step. Connect with our Taiwan regulatory affairs consultant today for a smooth and timely approval process.

FAQs

1. Can the clinical data from other countries be reused for product registration in Taiwan ?
Yes, it can be used in many cases. However, for new drugs or Class III medical devices, local trials or bridging studies may be requested.
The timeline varies based on product classification, but on average, it takes 6–12 months for Class II and Class III medical devices, and 9–18 months for pharmaceuticals.
No, each product can be registered under only one license holder in Taiwan. Changing the license holder requires a new registration.
Yes, TFDA provides priority review pathways for breakthrough, orphan, and pandemic-related products, subject to eligibility.
Such changes must be notified and may require supplemental applications or approvals, depending on their impact.

Still Have Questions ?

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Specialized Regulatory Affairs Services Across Multiple Industries

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

Expert Regulatory Services To Streamline Compliance

Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review

Regulatory Affairs Across Multiple Countries

India

Singapore

Mexico

Brazil

Vietnam

Malaysia

Argentina

Colombia

Taiwan

China

European

Thailand

Indonesia

Philippines

USA

Japan

Qatar

South Korea

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