Relabeler Medical Device

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

A relabeler does not include establishments that do not change the original labeling but merely add their own name. Remanufacturer - Any person who processes, conditions, renovates, repackages,...

MDCG Q&A on Repackaging and Relabeling Activities

https://www.regdesk.co/mdcg-qa-on-repackaging-and-relabelling-activities/

Nov 9, 2021. The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has …

FAQs about the New Device Registration and Listing …

https://www.fda.gov/medical-devices/device-registration-and-listing/frequently-asked-questions-about-new-device-registration-and-listing-requirements

FDA relabeler and repacker requirements for Medical devices

https://elsmar.com/elsmarqualityforum/threads/fda-relabeler-and-repacker-requirements-for-medical-devices.59627/

Repackaging and relabeling of a device and specification development are defined as manufacturing in 21 CFR Part 807, Establishment Registration and Device …

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=207.1

Relabeler means a person who owns or operates an establishment that relabels a drug. When not modified by "domestic" or "foreign," the term includes both …

Private label process for FDA - Medical Devices Group

https://www.medicaldevicesgroup.net/medical-devices/private-label-process-for-fda/

It appears the OEM medical device is imported into the U.S. and then relabeled with the private labeler’s name. As mentioned above, the private labeler is considered a …

EU MDR / IVDR for Medical Device Repackaging and Relabeling

https://www.healthecity.org/eu-mdr-ivdr-requirements-for-medical-device-repackaging-and-relabeling/

EU MDR / IVDR Requirements for Medical Device Repackaging and Relabeling. This post discusses the basics of the European Union (EU) Medical Device Regulation (MDR) and …

The UDI Rule: Are Private Label Distributors …

https://www.thefdalawblog.com/2016/08/the-udi-rule-are-private-label-distributors-to-be-considered-labelers/

The UDI regulation defines a “labeler” as a person who “causes” a label to be applied to a device. FDA notes that the labeler is usually the manufacturer, but …

Private Labeled Devices with FDA Approval

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

The relabeler will be responsible for maintaining records of each lot of product that is relabeled for the US subsidiary, and the relabeler must maintain …

Manufacturer, Wholesaler, Distributor, Broker | NH Office of ...

https://www.oplc.nh.gov/manufacturer-wholesaler-distributor-broker

Apply for a Prescription Drug/Device Manufacturer, Wholesaler, Distributor, Repacker/Relabeler, or Broker license (including Virtual Manufacturers/Distributors and …