Chapter 1 Taiwan TFDA administration information abstract

1. Administration and Abstract

Medical devices in Taiwan are mainly administrated by the Taiwan Food and Drug Administration (TFDA). It is mainly responsible for the classification of registration, registration requirements, audit process, market surveillance and adverse event monitoring of medical device.

2. Administrative Regulation

Medical Devices Act.

Regulations on Good Clinical Practice for Medical Devices.

3. Risk Level Classification

Taiwan administrative regulation divide medical devices into Class I, Class II and Class III.

4. Registration Language

Traditional Chinese.

Chapter 2 Registration Flow

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 Taiwan 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 Taiwan, and after approval by TFDA, it can be put into the Taiwan 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.