About Us
Your Regulatory Partner in Taiwan
PENGSYUAN is a regulatory affairs consulting firm specializing in Taiwan's medical device regulations. Our experienced team guides you through every step of the registration process, ensuring full compliance while identifying the most appropriate pathway to market approval for your devices.
Medical Device Registration
We provide comprehensive registration services, guiding manufacturers through device classification, pathway selection, and professional submission preparation. With our expertise, you can bring your medical devices to the Taiwan market with confidence and efficiency.
Local Agent Representation
As your local agent and license holder, we protect your ownership of registrations while providing comprehensive support, including license management, post-market surveillance, and ongoing compliance assistance.