change registration

Can Changes for New Standards Be Combined with Renewal Registration for In Vitro Diagnostic Instruments?

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01 / Question/ Can changes for new standards be combined with renewal registration for in vitro diagnostic instruments? 02 / Answer/ No. If the implementation of new standards involves substantial revisions to the technical requirements of the product, a separate change registration must be processed. WeChat Official Account Mass Spectrometry Medical Devices END Disclaimer: The … Read more