Taiwan: Guidance document for medical device usability engineering and contact lenses

Guidance document for evaluation of medical device human factors/usability engineering

Usability engineering has gained focus in recent times as an important part of risk management to minimise potential use errors of a medical device that may cause harm to users. Understanding the interaction between user and medical device. To help medical device manufacturers better understand the regulatory requirements for Taiwan, the Taiwan Food and Drug Administration has released ‘Guidelines for the Evaluation of Human Factors/ Usability Engineering of Medical Devices’.

Source: FDA Taiwan

Guidance document for pre-clinical testing of soft contact lenses

The Taiwan Food and Drug Administration has announced an amendment to pre-clinical benchmarks for soft contact lenses. A guidance document has also been provided as a reference for product development.

Source: FDA Taiwan

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