‧Our mission is:” Profession . Trust ” ‧TEBC Regulatory Affairs Department is focusing on importing every
innovative product for all the manufacturers and importers. Also, TEBC’s
professional teams can conduct clinical trials and PreMarketing Approval
in every phase.
TEBC offers a wide range of services to help sponsors whether in Taiwan or
overseas from design phase to approval and other needs. Our services include: .Preclinical study services
.Clinical trial design & management
.Quality System & Certificationn
.Preparation of medical device clinical trial submission documents
.Application for medical device clinical trial
.Application for qualification of medical device GMP
.Application for Quality System Document (QSD)
.Application for Medicine/ Medical device/ Cosmetics registration
.Other regulatory affairs
.How to apply for Medical Device License in Taiwan .Examples of applying for medical device license in Taiwan
Regulatory Affairs Department
Taiwan Eastsound Biotechnology Co., Ltd. TEL:+886-2-2314-1630 E-mail:ra@tebc.com.tw ADD: 4F.-3, No.2, Sec. 1, Zhongshan N. Rd., Zhongzheng Dist., Taipei City 100, Taiwan (R.O.C.)