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.

Services We Offer

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:

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.

Completed TFDA Application form with accurate product classification
Product formula /composition with detailed ingredients and their percentage
Manufacturing process and flowchart with GMP-aligned documentation explaining the product production, control and packaging process
GMP certificate for drugs/health foods or Quality System Documents (QSD) for medical devices
Free Sale Certificate (FSC)
Product labels and packaging in traditional Chinese including the product details (such as name, dosage, ingredients, usage, warnings, manufacturer/importer information)
Clinical efficacy data, if applicable (for new drugs, high risk devices or products with health claims)
Power of Attorney to represent the applicant locally by appointing a Taiwan Registered Agent (TRP)
Product samples or pictures reflecting the labelling and packaging clearly

Documents Preparation Tips

Why Artixio As Your Regulatory Affairs Consultant In Taiwan?

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.

2. How long does it take to get product registration approval in Taiwan?

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.