Taiwan’s TFDA Announces New Device Regulations

On November 27, 2023, Taiwan issued an amendment to the – Regulations Governing Issuance of Medical Device License, Listing, and Annual Declaration. Medical device registration in Taiwan includes two separate applications – 1. a dossier on the product and 2. a Quality System Documentation (QSD) submission for the manufacturing facility. Now, going forward all Taiwanese medical device product licenses must also include the QSD number too – except for 125 non-sterile Class I products. The QSD number was not required on the product approval in the past. Device products approved before the new regulation will not need to do this, but when prior device approvals need to be renewed, or a change notification is submitted, the QSD number will be required on all new registration certificates.

In Taiwan, device registration is done in a two-step process. First, the TFDA will do a preliminary review to see if the appropriate documents have been submitted, and then a substantial review will be done.

Also, under the new regulation, if documents are missing during the preliminary review, or there are other deficiencies, applicants will only have one month to fix such problems, whereas in the past, they had 4 months to do so. During the substantial review, applicants will continue to still have 3 months to respond to supplementary requests – similar to before. In addition, there are 140 device categories that can now be registered via a simplified pathway if they can submit a conformity statement. However, the simplified pathway for these 140 device categories only applies to similar products registered with the TFDA from the same device manufacturers.