Taiwan Medical Device Registration

Unlock the Taiwanese market with expert regulatory guidance, quality system oversight, and an independent Taiwan agent, with Cisema.

We help foreign manufacturers of Taiwan medical devices and IVDs in Taiwan successfully register their products with the Taiwan Food and Drug Administration (TFDA), meet all documentation and quality system documentation requirements, and maintain compliance across the device lifecycle. As your Taiwan Registration Holder (TRH), we manage your Taiwan medical device registration process from initial classification strategy through post-market surveillance.

With a presence in Taipei and a deep understanding of Taiwan’s Medical Devices Act, Cisema acts as your trusted in country regulatory representative. We provide complete support for device classification, technical reviews, quality system documentation QSD, and registration submission for Class I, Class II, and III devices.

Whether registering a new product, seeking amendments to your medical device permit license, or managing post-market obligations, Cisema gives you clarity, speed, and control.

From risk assessment and QMS alignment to TFDA application support and labeling compliance, we simplify your path to market. We also assist with documentation aligned to the Good Manufacturing Practice requirements and ISO 13485, ensuring conformity with Taiwan medical device expectations.