Fees to register and obtain licenses for the sale of medical devices in Taiwan will increase next year, the country’s Food and Drug Administration (TFDA) announced in August. Under the new fee structure, registration fees for Class I devices will increase from US$410 to US$590, and fees for Class II devices from US$950 to US$2,200. The cost of obtaining a Quality System Documentation (QSD) registration certificate will rise from US$1,360 to US$2,145. License renewals, which currently cost US$220, will rise to US$290, and license transfers and amendment fees will increase from US$540 to US$895. Direct import authorizations, currently assessed a fee of US$90, will cost US$145. The precise date the new fees go into effect has not yet been determined.
