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Your particular UK MDR conformity assessment basis (e.g., MDD-based, EU MDR-based, or direct UK MDR-based) needs to be known in order to answer definitively. But generally, when an economic operator like an importer or any other person (such as a healthcare organization) independently performs manufacturing ...

This is a very broad topic, and much can be said about it. But in a nutshell for purposes of this thread, my firm's training curriculum for our foreign clients highlights things like: Proactive early preparation and preplanning for a foreign FDA inspection FDA's legal authority FDA announcement ...

Your particular UK MDR conformity assessment basis (e.g., MDD-based, EU MDR-based, or direct UK MDR-based) needs to be known in order to answer definitively. But generally, when an economic operator like an importer or any other economic operator independently performs manufacturing operations like incorporating ...

IEC 62366-1 / EN 62366-1 (as amended, hereinafter "62366-1") represents the generally recognized state of the art; thus, conformity is often required (yet this ultimately depends on the particular jurisdictions in which the subject device will be marketed). 62366-1 normatively requires a certain approach ...

The presiding "District Office" in today's terms will either be your local District Office or, for medical devices, one of the three OMDRHO offices (see attached maps). But I'm not sure what the OMDRHO-equivalent is for pharma or veterinary. FOIA: Freedom of Information Act OAI: Official Action Indicated ...