By Stewart Eisenhart, Emergo Group
Taiwan’s medical device market regulator has published significant new fee increases for various aspects of their device review and approval process. The increases are set to take effect July 1, 2015.
The Taiwan Food and Drug Administration’s (TFDA) fee increases apply across new and modified device registrations, registration renewals and importation authorization; they will occur alongside anticipated changes to the TFDA review and approval process that will also be implemented July 1.
Fees for new device and quality system registrations
TFDA fees for registration of medical device manufacturers’ quality systems, known as Quality System Documentation (QSD) requirements, will nearly double, from USD 750 now to $1360 in July.
Registration costs for device classes will change as follows:
- Class I: from $375 to $360 (a decrease)
- Class II: from $375 to $900
- Class III: from $375 to $1370
- New/novel device: from $1125 to $2340
Fees for modifications to existing TFDA registrations
Registration modifications will also begin incurring higher fees starting July 1, according to the TFDA.
Making a manufacturer name change on a QSD approval letter, which currently costs $200, will cost $290.
Various product license changes will also cost more:
- Change to product indications: from $300 currently to $1080
- Change of registration due to new models or specification changes: from $300 to $900
- Adding new models to a registration: from $300 to $540
- Change of manufacturing site: from $300 to $540
- Transfer of registration: from $300 to $540
- Other changes: from $200 to $290
Renewal fee increases
The TFDA also plans to increase fees for renewals of QSD approval letters (from $750 currently to $1360) and product licenses (from $100 to $220). In addition, Taiwanese regulators will introduce a $90 fee for importation authorizations, which are currently provided at no cost.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.