The article reports on a guidance for classification of in-vitro diagnostics (IVD) for those who want to market internationally published by the Global Harmonization Task Force (GHTF). The guidance, which describes four categories...
document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in ...
The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in ...
This document providesguidance in relation to: i)the circumstances where a post-market clinical follow-up study is indicated; ii)the general principles of post-market clinical follow-up studies involving medical devices; and iii)the use of study information, including, for example, to provide info...
The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in ...