CGA M-21
- Guideline for Determining Pharmacovigilance Reporting Requirements in North America (for the U.S. & Reference for Canada)
- standard by Compressed Gas Association, 11/01/2017
- Category: CGA
$27.00
$14.00
Although both reporting for drugs and devices is required, this publication only addresses medical gases classified as drugs (pharmacovigilance) and does not address reporting requirements for gases or medical gas equipment classified as medical devices (materiovigilance).
In the United States, this publication should be used as a guideline for companies to comply with 21 CFR Part 314. In Canada this publication may only be used for a reference.
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