About Us
SINCE
2004
—
Your trusted partner
Elite RA Consultancy Co., established in 2004, is one of Taiwan's leading professional regulatory consulting companies specializing in medical device registrations. We provide a full range of services for both domestic and international medical device manufacturers, including medical device registration in TFDA, regulatory consulting, and product license management.
Upholding our mission of professionalism and integrity, we offer comprehensive, strategic, and timely regulatory guidance to help you navigate increasingly complex regulatory requirements. Acting as your regulatory representative in Taiwan, we facilitate communication with overseas manufacturers and proactively engage with the TFDA and relevant regulatory authorities on your behalf. Our goal is to ensure smooth progress of your applications and expedite approval for market launch.
With extensive experience in successful medical device registrations, we are committed to delivering reliable, professional, flexible, and highly efficient services. Our goal is to provide customized solutions that minimize unnecessary time and costs, ensuring your medical devices enter the target market smoothly — making us your most dependable partner.
Four Key
Advantages of
Choosing Us
20+ Years of Professional Experience
Proven track record in product registration for ophthalmology, cardiovascular, general surgery, IVD, and more.
Successful Registration of NEW Medical Devices
Expert guidance on clinical and technical documentation.
Professional Regulatory Consulting Services
In-depth support on QSD, product registration, marketing materials, and advertising compliance review.
QSD and License Holder Management
Acting as a neutral third-party license holder to ensure product accessibility and distribution continuity.