Initial Distributor Medical Devices

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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

Initial Importer - Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user ...

Establishment Registration and Medical Device Listing …

https://www.fda.gov/medical-devices/device-registration-and-listing/establishment-registration-and-medical-device-listing-files-download

Sterilize Medical Device for Another Party (Contract Sterilizer) 3: Export Device to the United States But Perform No Other Operation on Device: 4: Initial …

US Importer and Distributor Requirements - Donawa

https://www.donawa.com/wp-content/uploads/2019/06/5-US-Importer-Distributors-June2005-MDT-issue.pdf

A medical device manufacturer who exports products to the United States (US) may risk ... Device Listing for Manufacturers and Initial Importers of Devices, FDA defines “initial …

Device Registration and Listing | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at: Phone: 301-796-7400. Email: …

Distributor Registration - FDA Registration Requirements for a …

https://elsmar.com/elsmarqualityforum/threads/distributor-registration-fda-registration-requirements-for-a-distributor.47796/

Medical Device License as Distributor: Canada Medical Device Regulations: 12: Nov 5, 2021: M: MDSAP required for Device Initial Importer/Distributor …

Private Labeled Devices with FDA Approval

https://medicaldeviceacademy.com/private-labeled-devices-with-fda-approval/

Answer to the fourth question about private labeled devices. If the distribution company is the initial importer of a device into the USA, then the distributor …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling …

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 …

Importing Medical Devices | FDA

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

The following is an example of a medical device classification search for a manual toothbrush. Depending on the Class of the medical device you are importing, the …

MDR - Distributor Requirements (that also affect the manufacturers)

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

The requirements set for the distributor by the Medical Device Regulations MDR are derived from a superordinate framework for marketing of products. This is also …

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