Taiwan Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for Taiwan.

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Major Regulations
Document Number Published Language
Log in Medical Devices Act English
Log in Enforcement Rules of the Medical Devices Act English
Log in Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration English
Log in Regulations for Medical Device Quality Management System Inspection and Manufacturing License Issuance English
General Guidance Documents
Document Number Published Language
Log in Regulations for Medical Device Recalls
Log in UDI Requirements for Medical Device Labeling
Log in Regulations for Reporting Serious Adverse Events of Medical Devices
Log in Guidelines for In Vitro Diagnostic Medical Device Inspection and Registration
Log in Regulations Governing the Classification of Medical Devices
Log in Medical Device Quality Management System Guidelines English