Z
zippyoh
Dear all,
I hope you can help?
We are an Importer of OB Self-Test IVD Pregnancy Test Kits, OEM in China. As this IVD is not listed in Annex II, are we able to take the Annex III conformity assessment route? We don't need Annex IV full QA - right?
Many thanks
I hope you can help?
We are an Importer of OB Self-Test IVD Pregnancy Test Kits, OEM in China. As this IVD is not listed in Annex II, are we able to take the Annex III conformity assessment route? We don't need Annex IV full QA - right?
Many thanks