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TFDA Regulations

Regulations for Reporting Serious Adverse Events of Medical Devices

Regulations for Reporting Serious Adverse Events of Medical Devices
TaiwanTaiwan Food and Drug AdministrationVigilance
What this code is

Regulations for Reporting Serious Adverse Events of Medical Devices is the official TFDA identifier for “Regulations for Reporting Serious Adverse Events of Medical Devices”. Regulations for Reporting Serious Adverse Events of Medical Devices is the official identifier TFDA uses for this instrument.

Instrument
Regulations
Full name
Regulations for Reporting Serious Adverse Events of Medical Devices
Category
Vigilance
Source links
Authority source
Chinese
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
11 articles · 2 language versions
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
April 28, 2021
Effective
Readable full text

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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

About this regulation

Regulations for Reporting Serious Adverse Events of Medical Devices

Authorized subordinate pcode L0030124, announced 28 April 2021. 11 articles. Chinese controlling text plus authority English translation.

Regulations for Reporting Serious Adverse Events of Medical Devices is the official identifier TFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.