On March 17, 2026, the Taiwan Food and Drug Administration (TFDA) held its latest industrial communication meeting, signaling a major shift toward digital transformation and streamlined approvals across the product lifecycle.
The regulatory landscape for medical devices in Taiwan continues to evolve rapidly, with a clear emphasis on digitalization, regulatory efficiency, and alignment with international standards.
Read to learn more:
Medical Device Regulations and Management Communication Discussion Meeting Slides
(Traditional Chinese only) [PDF]
Purpose of the Meeting
To communicate upcoming regulatory developments and ongoing initiatives in medical device regulation, covering pre-market review, post-market surveillance, and international cooperation.
Key Developments
1. Digitalized Submission System
TFDA is transitioning to a paperless system.
The implementation of mandatory electronic submissions for specific application categories, along with the extension of the 90-day temporary file storage period, is designed to reduce administrative friction.
Expect more efficient submission workflows and a more predictable registration timeline.
2. PCCP: Streamlining Software Updates
Software-as-a-Medical-Device (SaMD) remains a priority area.
TFDA is promoting the Predetermined Change Control Plan (PCCP), allowing AI/ML-enabled devices to undergo post-market modifications without constant re-filing.
TFDA is also considering expanding PCCP to general medical device software, potentially reducing regulatory burden for frequent software updates.
3. Clarity in Pre-Clinical Requirements
New technical/reference guidelines have been issued for certain categories, including:
- Bone Anchor
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Liquid Chemical Sterilants / High Level Disinfectants
- Animal-Derived Materials
Clearer criteria and testing requirements aim to ensure submission data integrity, minimize supplementary requests, and accelerate approval timelines.
4. Expanding Market Opportunities & Regulatory Incentives
TFDA is reviewing the expansion of online sales channels for certain Class II medical devices.
This may create new opportunities for digital commerce and direct-to-consumer distribution.
Discussions are also underway to:
- Optimize Class I registration fees
- Extend listing validity periods
These measures aim to improve business efficiency for the medical device industry in Taiwan.
2025 Achievements
Pre-market Review Management
- Announced the “2025 List of Recognized Medical Device Standards”.
- Released 10 pre-clinical guidelines (including diagnostic imaging, IVD products, clinical trials, assisted reproduction, etc.).
- Announced amendments to the “Regulations Governing Border Inspection and Examination of Imported Medical Devices,” including “Quality Acceptance Criteria of Border Inspection and Examination of Imported COVID-19 Antigen Home/Self-Test”.
Post-market Surveillance Management
- Launched the “Medical Device Shortage Online Reporting” platform, implementing a daily reporting mechanism to ensure supply stability.
International Regulatory Cooperation
- Re-elected as the Chair of GHWP WG3.
- Maintained active participation in IMDRF working group meetings as an affiliate member.
- Engaged in bilateral exchanges with Australia, Japan, APEC, and APACMed to share experiences regarding UDI, PCCP, and joint reviews.
Implications to Client
- Manufacturers seeking to enter or expand in Taiwan should align regulatory strategies with TFDA’s digital transformation initiatives and evolving software oversight framework.
- Particular attention should be given to PCCP implementation, updated pre-clinical guidelines, and potential changes affecting online sales and listing validity.
- Early planning and proactive compliance will be key to leveraging these regulatory developments effectively.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Taiwan, please contact info@nordpacificmed.com.