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.
July 16, 2025
Approximately 5 minutes
Taiwan IVD Product Registration: High-Risk Classification and Mandatory QSD Compliance
Taiwan IVD Product Registration: High-Risk Classification and Mandatory QSD Compliance
In Taiwan, the regulation of In Vitro Diagnostic (IVD) products falls under the Taiwan Food and Drug Administration (TFDA), adhering to the new Medical Devices Act enacted in May 2021. For imported IVDs, manufacturers must appoint a Local Agent to serve as the official regulatory representative.
IVD Classification and Registration
IVD products are classified based on risk from Class I (Low Risk) to Class III (High Risk), plus a New category for devices without a predicate.
A critical distinction for IVDs in Taiwan is the registration requirement:
- Class I and Class II IVDs: These low to medium-risk devices do not require product registration with the TFDA.
- Class III and New IVDs: These high-risk products require mandatory registration and are subject to both Administrative and Technical Reviews by the TFDA.
The registration process requires key documentation, including an application form, a Free Sale Certificate from the country of origin, the manufacturer's authorization letter, Chinese labeling, preclinical test reports, and quality control procedures. Clinical Investigation Reports and a Literature Review are specifically required for Class III and New IVD products.
Quality System Documentation (QSD)
Before a registrable IVD can be legally marketed, the manufacturer must obtain approval for its Quality System Documentation (QSD). This documentation verifies the manufacturer’s compliance with Taiwan’s Good Manufacturing Practice (GMP) standards.
- Mandatory Requirement: QSD approval is mandatory for all registrable IVDs (Class III and New).
- Timeline: The QSD review process typically takes between 6 to 8 months and runs concurrently with the product application review. Final license issuance is contingent upon QSD approval.
The TFDA license, once approved, is valid for 5 years.
Fees and Timelines for Registrable IVDs
| Category | Application Timeline | QSD Timeline | TFDA Application Fee (NT$) | QSD Application Fee (NT$) |
|---|---|---|---|---|
| Class III | 9–14 Months | 6–8 Months | NT$100,000 | NT$39,000 |
| New (No Predicate) | 10–15 Months | 6–8 Months | NT$70,000 | NT$39,000 |