Pharmaceutical Manufacturer's obligations - Laboratory Test instruments

Avraham Harris

Involved In Discussions
A manufacturer of a device that will be used for QC testing during pharmaceutical manufacture, is asking whether FDA or FTC have any demands from the manufacturer of such equipment prior to import and commercialization.

Specifically, what else must be considered other than IEC 61010-1 compliance, FCC conformity/testing, USP <1058> conformity in terms of qualification (if required of the device manufacturer), Software validation (who checks this upon import?)?

Does the label have any particulars other than FCC?

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