Requirements for Importing Hydrocolloid Bandages into the US from China

P

private label

#1
Hello everyone,
Thanks for taking the time to read this, and hopefully for your valuable insight.
I am currently negotiating with a Chinese manufacturer who will produce hydrocolloid and adhesive bandages for me. Im planning to bulk ship the bandages in printed wrappers to the US to my warehouse where they will be assembled into retail packaging and sell them through a convenience store distributor.

These will be branded products - ie the wrappers are printed with a logo as is the secondary packaging.

My questions are:
1: Do i need to register as a manufacturer with the FDA and obtain 510K?
2: Do i need to submit the bandages for testing upon receipt?

I would really appreciate some advice regarding this issue, and any other issues which i may be facing and not realize :whip:

:thanx:
Thanks
D
 
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P

private label

#3
i couldnt post the links - so i copied the text to the FDA's product classification page for class 1 medical devices - it appears our bandages.are exempt from 510K submission

Based on the above discription of what we are trying to do am i reading this correctly?


Device dressing, compression
Regulation Description
Elastic bandage. Regulation Medical Specialty
General Hospital
Review Panel General & Plastic Surgery
Product Code MHW
Submission Type 510(K) Exempt
Regulation Number 880.50756
Device Class 1
Total Product Life Cycle (TPLC)
TPLC Product Code Report7
GMP Exempt?No
Note: FDA has exempted almost all class I devices (with the exception of reserved devices8) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16,
1996. It is important to confirm the exempt status and any limitations that
apply with 21 CFR Parts 862-8929. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892
If a manufacturer's device falls into a generic category of exempted class I devices as defined in
21 CFR Parts 862-89210, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment.

Thank you
 
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