"Your product falls under our Prohibited Products Policy." on TikTok Shop: what it means

TikTok Shop's public guide presents this as a product rejection reason and lists medical devices among the possible policy areas. It doesn't identify which area applies to your listing. If your product makes medical claims, the following checks address its device paperwork.

The things you must have

• FDA device registration and listing: Your factory registers and lists devices with FDA; you'll ask for those records.

• Country of origin marking: Your factory supplies English markings.

• Importer registration and customs bond: Your broker files CBP Form 5106; they'll arrange bonds for formal entries.

Check these first

If your product is a medical device, you'll need to check the FDA establishment registration when asking your factory for the paperwork covering its manufacture. If your product is a medical device, check its FDA product listing with your factory when reviewing the device documentation supplied for the finished product. If your product is an electronic thermometer, you'll need the manufacturer's existing FDA clearance information when checking the authorization paperwork supplied for that thermometer model. If your product's device testing needs checking, ask for further verification because the mandatory laboratory tests haven't been verified for this group of medical products. If your product's medical device labeling needs checking, seek further verification because the labeling requirements haven't been verified for this group of medical claim products.