In an effort to accelerate the medical device registration process, the Taiwan Food and Drug Administration (TFDA) has launched in January the TFDA Medical Device Pre-Market E-Submission System, which enables manufacturers to submit documents for their pre-market applications and renew licenses digitally. The new online platform had been developed since 2018, and due to increasing demand for electronic applications instead of paper applications, the TFDA officially launched the paperless platform earlier this year. This development is in line with TFDA’s commitment to optimize the pre-market review of medical device products according to international standards, which was also reflected in the implementation of the Medical Device Act in May 2021.
Currently, the digital submission platform is still in its pilot stage, so it is not mandatory to use this platform except for license renewals starting this July. There are no advantages at this time for paper verse electronic submissions with respect to the documents that need to be submitted and the processing time. Please note that sometimes the reviewer has trouble seeing uploaded documents, and thus it is best to always confirm receipt with the reviewer.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article:https://www.mohw.gov.tw/cp-5277-67863-2.html