Define Medical Device Distributor

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Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

What is a medical device? The FDA defines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article,...

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=807.3

(t) Wholesale distributor means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the …

Who Must Register, List and Pay the Fee | FDA

https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee

Remanufacturer - Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's …

Medical Supply Distribution: How to become a medical …

https://www.medilexonline.com/medical-supply-distribution/

A medical device distributor is an enterprise or individual dedicated to creating connections with medical equipment brands to later offer their products to the final …

What are the Distributor Requirements under EU MDR and IVDR?

https://www.greenlight.guru/blog/distributor-requirements-eu-mdr-ivdr

MDR defines a distributor as ”any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the …

MDR - Distributor Requirements (that also …

https://www.johner-institute.com/articles/regulatory-affairs/and-more/distributor-requirements/

Definition: Distributors “Distributors” are any natural or legal person in the delivery chain, who provide a product on the market up to the time of commissioning, …

FDA definitions - Repackager vs. Domestic Distributor

https://elsmar.com/elsmarqualityforum/threads/fda-definitions-repackager-vs-domestic-distributor.63677/

(h) Distributor means any person who furthers the distribution of a device from the original place of manufacture to the person who makes delivery or sale to …

Which MDR requirements apply to distributors of medical devices?

https://decomplix.com/mdr-requirements-medical-device-distributors/

A QMS ensures that only medical devices are distributed that achieve conformity and that non-compliant, faulty or unsuitable medical devices are …

Medical Device Distributors for the Medical Device Industry

https://www.medicaldevice-network.com/buyers-guide/medical-device-distributors/

Medical device network has listed the top medical device distributors based on its intel, insights, and decades-long experience in the sector. The list includes companies that …

Medical device distributor Definition | Law Insider

https://www.lawinsider.com/dictionary/medical-device-distributor

Related to Medical device distributor. means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to …

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