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	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	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