We aid manufacturers in the initial classification of their medical devices, gathering all necessary registration materials, and submitting them in a
professional manner.
We provide assistance to foreign manufacturers in obtaining QSD certification to ensure compliance with industry standards.
We offer regulatory strategic planning services based on our extensive understanding of the TFDA regulatory system.
We assist domestic distributors in setting up a quality management system that meets the standards required to obtain a GDP certificate.
We serve as your liaison with regulatory authorities and assist with product registration, vigilance, and reporting adverse events.
We assist in applying for NHIA reimbursement and help you secure a higher price than the reimbursement amount.
Why Choose Us?
>100
Obtained more than 100 TFDA registrations for “New Medical Device”
>60
Obtained more than 60 TFDA registrations for “High-Risk
Medical Devices”
>400
Obtained more than 400 Class III medical device registrations
>1700
Obtained more than 1700 Class II medical device registrations
>800
Completed more than 800
QSD registration /license renewal
Solid Experience
Having over 18 years of experience, we have managed to fulfill the needs of over 350 clients and have effectively registered over 2500 medical devices.
Expert Representative
Our group of experts will assist you in navigating through all the stages involved in TFDA registration procedures and rules.
Post-market Support
We provide assistance with post-market surveillance, which involves reporting Serious Adverse Events (SAEs) and device recalls as needed.
Regulatory Radar
Our team will keep you updated on any potential regulatory changes in Taiwan that may affect your devices.
Trustworthy
We protect your intellectual property and ensure your business interests are safeguarded.
Global Perspective
Our global perspective enables us to create effective strategies that meet the diverse needs of our foreign clients.
Contact
10F., No.221, Sec. 3, Beixin Rd.
Xindian District, New Taipei City
231 Taiwan
+886 2 29108777