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REGISTRATION CERTIFICATE in vitro TESTING WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSESection 31.11 of 10 CFR Part 31 establishes a general license authorizing physicians, clinical laboratories,
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Registration certificate in vitro is a document required by regulatory authorities for manufacturers of in vitro diagnostic medical devices to legally market their products.
Manufacturers of in vitro diagnostic medical devices are required to file registration certificate in vitro.
Registration certificate in vitro can be filled out by providing detailed information about the medical device, its intended use, manufacturing process, and quality control procedures.
The purpose of registration certificate in vitro is to ensure the safety, efficacy, and quality of in vitro diagnostic medical devices marketed in a particular region.
Information such as device classification, risk assessment, labeling, clinical evaluation, and post-market surveillance data must be reported on registration certificate in vitro.
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