FDA relabeler and repacker requirements for Medical devices

Please any one can help me on FDA relabeler and repacker requirements for Medical devices ? If you have any check list please provide us.

Thank you
Sherley13

Requirements for what? A checklist for what?

Medical device companies are subject to many requirements. What is your specific concern or issue?

Thank you for your response.

Distributor or wholesaler what documents should maintain as relabler?

As the FDA states in http://www.fda.gov/MedicalDevices/D...dicalDeviceQualitySystemsManual/ucm122391.htm

Repackaging and relabeling of a device and specification development are defined as manufacturing in 21 CFR Part 807, Establishment Registration and Device Listing for Manufacturers of Devices.

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To sort out all the applicable requirements, you could start here:

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/default.htm

Cheers,
Ronen.

sherley13 said:

Distributor or wholesaler what documents should maintain as relabler?

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At least in common USA/Canada/EU practice, distributors and wholesalers don't normally apply/change device regulatory labeling.

Normally US FDA does not regulate distributors and wholesalers, except for their possible roles in tracking; field actions (recall/correction etc.); complaint/adverse-event-report passthrough; radiation device reporting if their products are subject to those rules; and/or if they also have an Initial Importer role.

Thank you .

Sherley13