Frequently Asked Questions
Does my Taiwan Agent need to appear on the labeling?
Yes, as the Taiwan Agent’s information must be included on the Chinese label, along with the registration number. The distributor will also usually add their information with a sticker. the Taiwan Agent’s name and address must be listed on the label and packaging (in Chinese language).
Is ISO 13485 required?
Technically, no. However, for non-US and non-Japanese manufacturers, an on-site audit by the TFDA is the only alternative to providing an ISO 13485 certificate for the QSD Letter Application (which is applicable to some Class I, and all Class II and III devices, including high risk and new devices). US companies can alternatively submit a Certificate to Foreign Government (CFG) issued by the FDA. Japanese manufacturers can alternatively submit their Japanese QMS audit report and certification issued by the PMDA or RCB, as applicable.
Can registration certificates be transferred?
Yes, the Taiwan Agent responsibility can be transferred as long as the original Agent cooperates, as the request must be submitted by both agents. Additionally, the registration letter can be transferred simultaneously with the QSD Approval Letter.