With a solid business foundation dating back to 1968, TÜV SÜD Japan was established in 1993 to meet the increasing demand for enhanced quality and safety testing and certification in the Japanese market. TÜV SÜD Japan is representing TÜV SÜD Product Service, the Notified Body for most European Directives and also accredited by Ministry of Health, Labor and Welfare (MHLW) as registered certification body for medical devices in Japan. Qualtech was invited by TÜV SÜD Japan to give the seminar of regulatory registration in Taiwan on May 28. In this seminar, our senior regulatory manager (Juliana Chang)has honor to introduce the framework and current situation of TFDA, how to apply the Quality System Documentation and product, clinical trial, new regulation and so on.

After the conference, all of the participants responded so enthusiastically. It created a good opportunity for the Japanese manufacturers, distributors, or anyone who is interested in Taiwan market in medical sector. Furthermore, We would like to held more conference about regulation in the future. We hope that information will be helpful for you.