Eric Leung

“The Taiwan FDA has announced a price increase for many regulatory items, and this notice has been in effect since May 1st, 2021.”

Eric Leung
General Manager
Asia Actual Taiwan

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Taiwan FDA Increased Regulatory Fees

Published on: May 13th, 2021

The Taiwan FDA has announced a price increase for many regulatory items, with some seeing an increase as much as 163%. This notice went into effect on May 1, 2021 and is the 2nd time the TFDA has raised their fees in the last 6 months. Manufacturers of Class I products can expect to pay less than $600 for market access while new manufacturers with a Class III product will need to budget $6,000 for government fees.

For pricing details, please refer to the table below.

Item Previous Fee Current Fee (From May 1st) % Change
Class I Registration NT$ 10,000

(US$ 357)

NT$ 15,000

(US$ 536)

50%
Class II Registration NT$ 25,000

(US$ 893)

NT$ 58,000

(US$ 2,071)

132%
Class III Registration NT$ 38,000

(US$ 1,357)

NT$ 100,000

(US$ 3,571)

163%
QSD Registration/Renewal NT$ 38,000

(US$ 1,357)

NT$ 60,000

(US$ 2,143)

58%
Indication Change NT$ 30,000

(US$ 1,071)

NT$ 40,000

(US$ 1,429)

33%
Specification Change (with impact on performance & safety) NT$ 25,000

(US$ 893)

NT$ 35,000

(US$ 1,250)

40%
Specification Change (without impact on performance & safety) NT$ 15,000

(US$ 536)

NT$ 25,000

(US$ 893)

67%
Model Addition NT$ 25,000

(US$ 893)

NT$ 35,000

(US$ 1,250)

40%
Manufacturing Site Change NT$ 15,000

(US$ 536)

NT$ 25,000

(US$ 893)

67%
Device Registration Transfer NT$ 15,000

(US$ 536)

NT$ 25,000

(US$ 893)

67%
QSD Registration Transfer NT$ 8,000

(US$ 286)

NT$ 10,000

(US$ 357)

25%
Device Renewal NT$ 6,000

(US$ 214)

NT$ 8,000

(US$ 286)

33%
Copy of Device Certificate NT$ 1,500

(US$ 54)

NT$ 1,500

(US$ 54)

0%

Registration Process Overview in Taiwan

In Taiwan, medical device registration is overseen by the Taiwan Food and Drug Administration (Taiwan FDA), a division of the Ministry of Health and Welfare. Class I devices will go through an Administrative Review, and Class II, III, and New devices (no predicates) will go through both an Administrative and Technical Review, as well as a Quality System Document (QSD) Review. While fees have increased in Taiwan, the review fees are still relatively affordable compared to other markets in the region.

Once issued, licenses are valid for 5 years. Licenses in Taiwan are transferrable and will need to be completed by both the transferor and the transferee jointly. To learn more about the regulatory process in Taiwan, please click here.

Expedited Market Access For US/EU Approved Devices

Clinical data is only required for Class III IVDs and New products. Class II medical devices with approval in the US or EU can usually use existing documentation in place of the preclinical test, quality control procedure and test reports.

Grow with Us

Asia Actual is available to help navigate the medical device registration requirements and regulatory pathway for medical device and IVDs in Taiwan.

Contact Asia Actual for more information discussing the potential for your medical device or IVD in the Taiwanese market.

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