Goodmorning all, I have a question about the use of the IVD symbol on in vitro diagnostic products in USA. The IVD symbol as defined in ISO 15223 standard should be used to indicate "a medical device that is intended to be used as an in vitro diagnos...
Director, International Sales & Marketing at MorTan, Inc.
Is anyone aware of the FDA guidance documents to say what medical devices require specialized instructions for disposal? I’m not talking about ones with obvious hazards such as implantables or ones with sharps, but simple Class I single-use devices. ...
Dear all, I have a question about RUO and IUO labeling in US market.According to FDA guidance "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only": RUO product is an IVD product that is in the labor...
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Global medical device and life sciences product labeling is a complex subject and an integral part of the supply chain. The landscape is varied in terms of the systems and processes employed in designing, populating and printing labels (including boo...
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Consider the following: device OEM is in Germany, contract sterilisation is done in the UK, the OBL owner (and therefore Legal Manufacturer) is also in the UK. For labeling in the US market, which is the correct country of origin: Germany or the UK?s...