May 21, 2015
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:
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:
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.
The Taiwan Food and Drug Administration (TFDA) plans to implement significant changes to its registration and approval system for medical devices, according to Emergo consultants in Taipei.
A new study by the Taiwan Industry of Economic Affairs’ Industry and Technology Intelligence Services (ITIS) projects the country’s medical device industry to grow to $2.71 billion in 2013, an increase of more than seven percent.
According to the ITIS and BioSpectrum, the increase in Taiwain’s medical device sector will be driven primarily by demand for contact lenses and blood glucose monitors in the country. These two products will buy the entire medical device sector despite a nearly seven-percent decline between Q4 2012 and Q1 2013. The IT IS expects medical device sector growth of nearly 17% from Q1 to Q2 2013.