Taiwan FDA published new law on Electronic Manuals replacing Chinese Manuals for Medical Devices.
The Taiwan Medical Equipment and Cosmetics Group released an announcement that certain medical devices can replace their Chinese manuals with electronic manuals. This announcement is based on Article 33 of the Medical Device Management Law.
These electronic manuals can be provided through built-in Help systems, portable electronic storage devices, or manufacturer websites.
The labeling and packaging of the devices should include information about how to obtain a paper manual and contact information for the manufacturer.
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