Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
June 16, 2025
Approximately 5 minutes
Taiwan Medical Device Registration: Local Agent, Classification, and QSD Compliance
Taiwan Medical Device Registration: Local Agent, Classification, and QSD Compliance
Medical device regulations in Taiwan are overseen by the Taiwan Food and Drug Administration (TFDA), a division of the Ministry of Health and Welfare. The regulatory system is governed by the comprehensive Medical Devices Act, enacted in May 2021. For imported products, manufacturers must appoint a Local Agent or Importer to act as their regulatory representative.
Classification and Regulatory Pathway
The registration pathway, required documentation, and associated fees depend on the device’s classification:
- Class I (Low Risk): Requires only an Administrative Review. Most devices in this class have the shortest timeline (1–2 months).
- Class II (Medium Risk) & Class III (High Risk): Require both Administrative and Technical Reviews, leading to longer timelines (8–12 months and 9–14 months, respectively).
- New Device (No Predicate): A new category for devices without a previously approved predicate by the TFDA. These have the longest review timelines (10–15 months) and may require additional clinical data.
A key aspect of the process is identifying a predicate device (similar products previously approved by the TFDA) to support the application. Taiwan generally does not require approvals from reference countries (like the US or EU) as long as the device is registered in its country of origin and a Free Sale Certificate is provided.
Quality System Documentation (QSD)
Before a Class I (Sterile/Measuring), Class II, Class III, or New device can be marketed in Taiwan, manufacturers must demonstrate compliance with Taiwan Good Manufacturing Practice (GMP) standards through Quality System Documentation (QSD).
- Mandatory Scope: QSD approval is mandatory for all products except non-measuring, non-sterile Class I devices.
- Process: The QSD review can take 6–8 months and is often run concurrently with the device application review. Final registration approval is contingent on QSD approval.
- Expedited Pathway: Manufacturers can expedite the QSD process by utilizing an ISO 13485 certificate issued by one of the TFDA-approved Notified Bodies under the TFDA-EU Technical Cooperation Program (TCP III).
Key Registration Requirements
Required documents typically include:
- Application form and Authorization letter from the manufacturer.
- Copy of Chinese labeling, Instructions for Use (IFU), and packaging inserts.
- Free Sale Certificate (FSC) from the country of origin's health authority.
- Product structure, materials, specifications, and intended use documentation.
- Preclinical test reports and quality control procedures.
- Clinical Data: Required only for Class III In Vitro Diagnostic Devices (IVDs) and New products.
Once issued, a medical device license is valid for 5 years and is transferable between local agents with the joint execution of a transfer application.
| Category | Application Timeline | QSD Timeline | TFDA Application Fee (NT$) |
|---|---|---|---|
| Class I | 1–2 Months | N/A | NT$15,000 |
| Class I (Sterile/Measuring) | 7–8 Months | 6 Months | NT$15,000 |
| Class II | 8–12 Months | 6–8 Months | NT$60,000 |
| Class III | 9–14 Months | 6–8 Months | NT$100,000 |
| New (No Predicate) | 10–15 Months | 6–8 Months | NT$130,000 |