The Taiwan Food and Drug Administration (TFDA) recently announced plans to change the country’s medical device marketing authorization approval system starting July 1, 2015. Applicants will need to submit Quality System Documentation (QSD) Approval letters as part of the initial marketing authorization application package. Currently, the TFDA sometimes allows applicants to submit these QSD letters several months after the initial application package.
After an initial review of the administrative documentation, the TFDA will assess preclinical testing documents and factory quality control documents for higher risk medical devices. Safety, quality, and performance will be particularly scrutinized. Registration fees will also be raised.