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...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the principles of software validation. The scope of the document covers, inter alia, the aspects...
FDA
The present article details FDA guidance on software testing, including tests performed by the manufacturer (software developer) regarding potential changes to the software. The basics of software testing are described in the initial article. The Food and Drug...
FDA
The Food And Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the Global Unique Device Identification Database (GUDID). The document highlights the most important...
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the classification of general medical devices. The document describes in detail the applicable classification rules...
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