Hi everyone,
Ive been having trouble finding information about labeling requirements for IVDs that will be marketed in Ukraine, Turkey, and Russia. Our current CE IVD products general self-certified IVDS and FDA Class I exempt IVDS in USA. We are a manufacturer located in the United States and we have an authorized Rep for the EEA along with a few others for the other markets. I know for a fact that according to Directive 98/79/EC In Vitro Diagnostic Device requires a Authorized Rep's Information to be placed on labels, packaging and IFUs. Is this also the case for devices that will marketed in the countries that I have listed? Can someone show me a link for: (Decree of CMU №754) for Ukraine?
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Ramanjot Bhatia
Regulatory Affairs Specialist
SF Bay Area, CA
United States
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