Taiwan Market Update: Electronic Submissions, AI Guidance, Fee Revisions

Medical device regulators in Taiwan have recently announced several updates impacting market access requirements, including electronic market access submissions, devices with artificial intelligence (AI) components and administrative fees.

E-submissions for low-risk medical devices

First, the Taiwan Food and Drug Administration (TFDA) has begun accepting low-risk Class I medical device registration applications via the regulator’s Medical Device Premarket E-submission System (link in Chinese).

TFDA does not require any additional hard-copy documentation for qualifying registrants. However, the TFDA electronic submission system does not accept Class I device registrations subject to standard regulatory listing requirements, Class I device registration change applications or renewal applications.

Development principles for AI-enabled medical devices

Second, TFDA has published new guidance for development and management of AI-enabled devices based on best practices established by the International Medical Device Regulators Forum (IMDRF).

The TFDA document, Good Machine Learning Practices for Artificial Intelligence Medical Devices: Development and Management Principles, covers issues such as product design, software quality, data management and post-market performance monitoring for medical devices with AI components.

Draft revisions to medical device registration fees

Third, Taiwan’s Ministry of Health and Welfare (MOHW) has issued draft revisions to administrative fees for medical device market applicants. 

The MOHW’s proposed changes include updated fees for Class I and Class II device registration applications, registration renewal applications, listings and annual declarations. The MOHW revisions also include proposed fees for regulatory reviews of clinical trial changes pertaining to safety.

Public consultation for the proposed fee revisions is open through Aug. 28, 2026. 

Emergo by UL will provide updates on these and related medical device regulatory developments as they become available.