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General Device Labeling Requirements | FDA
- https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements
- The label of a device shall contain the name and place of business of manufacturer, packer, or distributor including the street address, city, state, and zip code. If the firm's street...
Importing Medical Devices | FDA
- https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices
- Registration and listing. Establishments that are involved in the production and distribution of …
Which MDR requirements apply to distributors of medical devices?
- https://decomplix.com/mdr-requirements-medical-device-distributors/
- Distributors have a verifying and ensuring function under the MDR (and IVDR) with regard to the medical devices that they make available on the market. This …
Symbols to be used on labelling (ISO 15223) …
- https://www.bsigroup.com/globalassets/meddev/localfiles/en-gb/webinars/bsi-md-symbols-and-information-to-be-provided-by-the-manufacturer-webinar-presentation-25-feb-2020.pdf
- Distributor Indicates the entity distributing the medical device into the localeThis symbol shall be accompanied by the name and address of the importing entity, …
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