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TFDA Regulations

Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration

Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration
TaiwanTaiwan Food and Drug AdministrationRegistration
What this code is

Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration is the official TFDA identifier for “Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration”. Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration is the official identifier TFDA uses for this instrument.

Instrument
Regulations
Full name
Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration
Category
Registration
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Chinese
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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27 articles · 2 language versions
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
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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 Governing Issuance of Medical Device License, Listing and Annual Declaration

Authorized subordinate pcode L0030128, last amended 27 November 2023. 27 numbered articles including official Article 13-1 in both Chinese and the authority English translation.

Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration is the official identifier TFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.