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Medical Device Regulatory Authorities in Taiwan, China

Regulation of medical devices in Taiwan, China is primarily the responsibility of the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare. The TFDA is primarily responsible for the classification of medical devices, registration requirements, review processes, market surveillance, and adverse event monitoring.

Official website link: https://www.fda.gov.tw/TC/index.aspx

Database Link: https://www.fda.gov.tw/TC/siteList.aspx?sid=11683

Regulatory Framework

Medical Devices Act

Good Clinical Practice Guidelines for Medical Devices

Medical Device Risk Classification

Taiwan’s medical device regulations classify medical devices into Class I, Class II, and Class III.

Registration Language

Traditional Chinese.

Registration Process, Timeline, and Official Fees

1.Registration Process

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2.Registration Timeline

Based on Wiselink’s project experience and relevant regulatory guidelines, the registration timeline for QSD applications is approximately:

3.Official Fees

QSD Application: Fee is NT$60,000 × 1.05 / Official Exchange Rate

QSD License Maintenance Fee: Charged every 3 years; fee is NT$60,000 × 1.05 / Official Exchange Rate

Class III Product License Application: NT$100,000 × 1.05 / Official Exchange Rate

Class III Product License Maintenance Fee: Charged every 5 years; NT$9,500 × 1.05 / Official Exchange Rate

Class II Product License Application: Fee is NT$58,000 × 1.05 / published exchange rate

Class II Product License Maintenance Fee: Charged every 5 years; fee is NT$9,500 × 1.05 / published exchange rate

Class I License Registration Application: Fee is NT$16,500 × 1.05 / published exchange rate

Class I Product License Maintenance Fee: Charged once every 5 years; fee is NT$9,500 × 1.05 / published exchange rate

Application for Classification Determination: Fee is NT$3,500 × 1.05 / prevailing exchange rate

Application for Authorization: Fee is NT$4,000 × 1.05 / prevailing exchange rate

Application for Written Inquiry: Fee is NT$4,000 × 1.05 / prevailing exchange rate

CCC Code Inquiry: No fee

Chapter 3 FAQ

Q: Does the medical device need a QMS certificate for TFDA registration?

A: QMS is required for TFDA registration, but TFDA does not directly recognize ISO 13485 certificates, and TFDA needs to confirm that the manufacturer's QMS complies with the manufacturing license requirements of China Taiwan region authority (Quality System Document, QSD).

Q: Can medical device products make a registration change after the completion of registration?

A: If the change of the medical device product meets the scope allowed by TFDA, the change application can be submitted by the local representative in China Taiwan region, and after approval by TFDA, it can be put into the China Taiwan region market.

Q: How long is the medical device registration certificate and QSD certificate valid?

A: Product registration certificate is valid for 5 years, QSD certificate is valid for 3 years.

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