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From GxPlex
Unit number this reference belongs to.
E
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIII Part A Section 2.3 +
1.2.8 +
I
E
1.3.0 +
1.3.0 +
G
1.3.0 +
U
USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 - +
1.3.0 +
USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 - +
1.3.0 +
W
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - 1.5 Regulatory requirements +
1.3.0 +
D
F