FDA
The new article provides a brief overview of the human factors validation testing and also addresses certain specific aspects associated thereto, including the ones related to the test participants. Table of Contents The Food and Drug...
FDA
The new article addresses specific factors related to empirical analysis (formative evaluation). Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
Asia
The first article provides an overview of the general provisions of a new draft regulation on clinical trials for medical devices. Table of Contents The Turkish regulating authority has published a draft regulation on clinical trials for medical devices....
Asia
The present article describes in detail a new resolution issued in Jordan, by the virtue of which the authority describes the medical device license renewal procedure. Table of Contents Jordan has adopted a new circular resolution establishing the...
China
Under the general rule, combination products constitute a specific group of products consisting of both medicine (drug) and medical device. In such a case, both products (medicine drug and medical device) are supplied together and intended to be used together for a...
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