Under the Taiwan Department of Health (DOH), Medical devices are regulated by the Bureau of Pharmaceutical Affairs (BOPA). The Taiwanese medical device classification system follows the United States FDA 21 Code of Federal Regulations for Class I, II and III Medical devices depending on the intended use and the indications for use.

Products are divided into Medical Devices and In Vitro Diagnostic Devices (IVD). Some IVDs are also considered medical devices and are subjected to both regulations. All devices require Quality System Documentation (QSD) registration with DOH. Local representative must be assigned for the registration process. Our country specific (*) regulatory services in Taiwan include:

Medical Device specific regulation strategy reports in Taiwan, Medical Device Registration with BOPA, BOPA Technical documents Preparation, license holder and local Authorized Representative in Taiwan, QSD registration and Arazy Group unique line of GlobaR - Global Regulatory Hub™ products. 

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

Please fill in the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Taiwan!

(*) Taiwanese Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.