AI-generated from the captured TikTok policy text. Verify against the TikTok source before acting.
TikTok Shop requires extra documentation for selling medical devices and medical supplies. Requirements depend on whether you are a manufacturer, importer, repacker, or reseller, and some products are invite-only or prohibited. Sellers must also follow the Restricted Products Policy and submit documents through the correct TikTok flow.
Key points
Medical devices and medical supplies may require category qualification in the Qualification Center.
Requirements vary by seller type: manufacturer/importer/repacker vs reseller.
Class III medical devices and prescription-required products are not permitted.
Class I and II products can require FDA registration/listing, 510(k) or exemption proof, label images, and invoice/proof of purchase.
Some products are invite-only or need product-specific documents during listing, not in Category Qualification.
Say / show
Submit documentation through the Qualification Center when required.
Use original, unmodified, clear, legible documents and images.
Make sure product photos, labels, and documents match the exact listed product.
Provide product instructions, manuals, safety info, labels, and warnings in the language of the intended country of sale.
Verify details against the TikTok source before acting.
Do not say / show
Do not list Class III medical devices.
Do not list products that require a prescription from a licensed healthcare provider.
Do not submit retail order confirmations or retail invoices as reseller proof.
Do not submit designated-product documents in the Category Qualification Center when TikTok says to upload them during product listing.
Do not claim electrical safety without approved testing or certification.
Violation risks
Category qualification rejection.
Removal of ability to sell in the category.
Account health point deductions.
Removal of product listings.
Enforcement action for inaccurate or fraudulent labeling or unsupported safety claims.
Who it affects
Manufacturers of medical devices and medical supplies.
Importers of medical devices and medical supplies.
Repackers of medical devices and medical supplies.
Resellers of medical devices and medical supplies.
Sellers of invite-only or designated products such as certain health devices, baby products, nebulizers, and hearing aids.
Source notes
This summary is based only on the provided TikTok source text.
TikTok says requirements vary by seller type and product category.
For category qualification rejections, TikTok directs sellers to review the rejection message and resubmit with updated documentation.
For designated products, TikTok says to upload required documents directly during Product Listing, not in Category Qualification.
Verify all requirements against the TikTok source before taking action.
Confidence: high · Model: gpt-5.4-mini · Prompt: creator-policy-summary-v1
Readable Policy Copy
Captured policy content rendered without TikTok navigation, scripts, tracking markup, or page chrome. Source: raw-html.
Key Points:
To sell Medical Devices and Medical Supplies, you may need to submit documentation through the Qualification Center.Requirements vary depending on your role as a seller.
This document outlines the requirements for selling Medical Devices and Medical Supplies on TikTok Shop. These rules are in place to ensure all products comply with applicable regulations and to protect customer safety. Medical devices and medical supplies are also subject to our Restricted Products Policy. Sellers must comply with both this document and the Restricted Products Policy when listing medical devices and medical supplies.
Medical Devices and Medical Supplies
Medical devices are regulated by the U.S. Food and Drug Administration (FDA). They are also classified based on their intended use. Click here to check if your product is a medical device and view its classification. The categories include products that are considered medical devices. The list is not limited to these examples.
Baby & Maternity
Pacifiers, teethers, teething relief, and dental care
Medical and PPE masks (including respiratory masks)
Ointments and antiseptics
Bandages, dressings, and liquid bandages
Heating pads, heating patches, and heating wraps
Saline sprays
Nicotine replacement products
Gums
Lozenges
Patches
Inhalers
Wheelchairs
The following health medical devices can be offered by invite-only sellers:
Glucose Monitors
Electric/manual blood pressure monitors
Cholesterol monitors
Glucose control solutions
Glucose kits
These products are only available to invite-only sellers and have additional requirements/best practices. See Promoting Sexual Wellness Products for more information.
Fertility thermometers
Ovulation and fertility test kits
Pregnancy tests
Male and female fertility tests
Male and female condoms
Lubricants
Prohibited Products
The following products are not permitted on TikTok Shop:
Class III medical devices
Products that require a prescription issued by a licensed healthcare provider
Requirements To Sell Medical Devices and Medical Supplies Class I and II
You may be required to pass category qualification to sell Medical Devices and Medical Supplies. This process requires submitting documents proving you are qualified to sell these products. Detailed requirements are listed in the sections below. Open each section to view what is needed.
Manufacturers, Importers, And Repackers
If you are applying to sell Medical Devices and Medical Supplies Class I and II you manufactured, imported, or repacked, you are required to submit the following documents:
Proof of FDA Establishment Registration & Device Listing
Manufacturers, importers, and repackers are required to submit proof of FDA Establishment Registration and proof of Device Listing. You can get this information from the FDA's Unified Registration and Listing System (FURLS). The following documents must be provided:
A screenshot of the FDA Establishment Registration number (21 CFR Part 807) from the FURLS
A screenshot of the FDA Device Listing (21 CFR Part 807) from FURLS
Each document must include:
The name and physical address of the registered establishment
The operation type of the establishment
Confirmation that the registration is valid at the time of submission
Additional requirements:
Screenshots must show that they were taken from the official FDA FURLS website
All documents must be authentic and remain in their original (unmodified) format
510(K) Pre-Market Notification or Proof of Exemption (Class II only)
Manufacturers, importers, and repackers selling Class II medical devices must submit one of the following:
FDA 510(k) Premarket Notification approval letter (21 CFR 807 Subpart E), or
Proof of 510(k) exemption from the FDA’s Product Classification database
The document must include:
The name of the manufacturer or importer
The product name and category that matches the listing on TikTok Shop. This includes the product description and details
Additional requirements:
All documents must be authentic and remain in their original (unmodified) format
Product Label Images
Class I Medical Devices
Manufacturers, importers, and repackers must provide images of the product and its packaging. The images must meet the following requirements:
Show all sides of the product and packaging
Be clear, legible, complete, unedited, and in color
Have a minimum resolution of 600 × 600 pixels
Avoid black-and-white, angled, blurry, cropped, or edited images
Ensure all information on the product and packaging is visible and legible. This includes product description, warning logos, and any other required information
Class II Medical Devices
Class II medical devices must meet labeling requirements under 21 CFR Part 801 and provide the following in product and/or packaging photos:
Brand name
Device name
Name and place of business of the manufacturer, packer, importer, distributor, or authorized representative, including street address, city, state, and postal code
Compliance markings
Intended use
When submitting images or documents that include images, ensure the following:
Images are clear and legible
Images reflect the product listed on related documents. This may include FDA documentation or invoices
Product instructions, manuals, safety information, labels, and warnings are provided in the language of the intended country of sale
If the product is a set or bundle, include images of each individual item
Resellers
If you are applying to sell Medical Devices and Medical Supplies Class I and II as a reseller, you may be required to submit the following documents:
Purchase Invoice or Proof of Purchase
Resellers must submit a legible purchase invoice or proof of purchase issued by the product’s manufacturer or distributor. The invoice must meet all of the following requirements:
Be dated within the last 180 days
Show the same name and address as the selling account
Include the full name and address of the manufacturer or distributor
Contain products belonging to the applicable category
Reflect a combined purchase of at least 400 units
Be written in English or Chinese
Additional Information:
Pricing information may be omitted (optional)
TikTok Shop reserves the right to verify the submitted documentation by contacting the product vendor listed on the invoice
Retail order confirmations or invoices are not accepted
Product Label Images
Class I Medical Devices
Resellers must provide images of the product and its packaging. The images must meet the following requirements:
Show all sides of the product and packaging
Be clear, legible, complete, unedited, and in color
Have a minimum resolution of 600 × 600 pixels
Avoid black-and-white, angled, blurry, cropped, or edited images
Ensure all information on the product and packaging is visible and legible, including product description, warning logos, and any other required information
Class II Medical Devices
Class II medical devices must meet labeling requirements under 21 CFR Part 801 and provide the following in product and/or packaging photos:
Brand name
Device name
Name and place of business of the manufacturer, packer, importer, distributor, or authorized representative, including street address, city, state, and postal code
Compliance markings
Intended use
When submitting images or documents that include images, ensure the following:
Images are clear and legible
Images reflect the product listed on related documents. This may include FDA documentation or invoices
Product instructions, manuals, safety information, labels, and warnings are provided in the language of the intended country of sale
If the product is a set or bundle, include images of each individual item
Additional Requirements
These requirements are in addition to the documentation required under your seller type above. Open each section below to see the specific requirements for different types of medical devices.
Electrical Medical Devices
For Manufacturers or Importers:
A valid Certification of Compliance/Conformity (COC) accredited by the Occupational Safety and Health Administration (OSHA). The COC must:
Include a clear description and details of the tested product
Match the product being listed on TikTok Shop
List all safety standard tests performed with Pass/Fail indicators
Be issued within the past 2 years
Include the name and address of the accredited laboratory
Correspond to the product photos submitted
Image of a valid Product Electrical Safety Marking
Image of a valid Product FCC Safety Marking (if the product has Bluetooth or Wi-Fi)
For Resellers:
Image of a valid Product Electrical Safety Marking
Image of a valid Product Federal Communications Commission (FCC) Safety Marking (if the product has Bluetooth or Wi-Fi)
Surgical N95 Respirators
Surgical N95 respirators are Class II medical devices and require additional labeling. Required images and information include:
Product Label on Mask:
Approval Holder / Company name
Model or Part number
"Surgical N95 Respirator" text
TC-Approval Number
National Institute for Occupational Safety and Health (NIOSH) (in capital block letters)
Lot number
Packaging Label:
Expiration date / Use by date
Packaging Label and/or Insert:
Full NIOSH surgical N95 respirator approval label, often located on or within the packaging
PPE Masks (Medical masks with liquid barrier protection)
PPE masks are Class II medical devices and require additional labeling. Required information includes:
Due to safety and compliance considerations, only select qualified sellers are permitted to offer these products on TikTok Shop. In addition to the standard documentation required for your seller type, qualified sellers must submit:
Certificate of Analysis (COA)
The COA verifies product quality, safety, and regulatory compliance. It must:
Contain a clear description and relevant details of the tested product
Be issued within the past 2 years
Match the product being listed
List all safety standards tested
Include the name and address of the accredited testing laboratory
Be provided in English
Be clear, unaltered, and legible
Designated Products (Listing-Level Qualification)
Certain designated products require additional compliance documentation to be submitted and approved for each product. This includes:
Pacifiers, Teethers, and Dummies
Baby Sunglasses
Nebulizers
Hearing Aids
Required DocumentationFor the specific products listed above, you must submit the appropriate safety documentation. Make sure all documents match your product exactly.
Children's Product Certificate (CPC) and Lab Test Reports
(For Pacifiers, Teethers, Dummies, and Baby Sunglasses)You must provide a valid CPC and a Consumer Product Safety Commission (CPSC)-accepted Lab Test Report that meets the following rules:
Date: Issued within the last 365 days.
Match: The product name and model on the report must exactly match your product listing.
Results: Must show a "Pass" result for all applicable CPSC safety standards (such as Consumer Product Safety Improvement Act (CPSIA) Section 108 for Phthalates and 16 CFR 1501 for Small Parts). TikTok Shop must not be listed as the importer or responsible party.
Specific Medical Device Testing
(For Nebulizers and Hearing Aids)You must provide the required product-specific safety testing documentation or clearance required by the FDA or relevant governing body for these specific devices. How to SubmitIf you are listing any of the designated products mentioned above, you must upload the required documentation directly during the Product Listing process. This includes the CPC, Lab Test Report, or specific device testing. Your listing will remain under review until the product-specific documents are verified. Do not submit these documents in the Category Qualification Center.
Enforcement Actions and Appeals
Claiming electrical safety without approved testing or certification violates these requirements. Tests and certifications must come from recognized electrical safety or FCC laboratories. Products are also in violation if they have inaccurate or fraudulent labeling. We regularly review your shop’s compliance with this document and our Restricted Products Policy. If any violations are identified, TikTok Shop may take enforcement action at our sole discretion. This may include, but is not limited to:
Rejecting your category qualification application
Removing your ability to sell in this category
Deducting points from your account health
Removing product listings
For more information on enforcement actions, see our Seller Enforcement Policy. If you'd like to appeal an enforcement action, visit the Appeals section.
How to Submit Your Documentation
For categories under category qualification, submit your documentation via the Qualification Center in Seller Center. Click here or follow these steps:
Log into your Seller Center account.
Click your shop icon in the top right corner.
Go to My Account > Account Settings.
Select Qualification Center.
Click on Category Qualification.
Click Add Category Authorization and follow the prompts to submit your application.
Product-Specific Documentation
Submission Some products require additional documentation when being submitted through Seller Center. This includes certain Over-the-Counter (OTC) products. To submit product-specific documentation:
Select Add product. Begin entering your product information, category, images, description, details, and so on.
Fill out the Product Compliance section and submit your documents.
Once all information has been added (including shipping information), select Submit for review.
How To Address A Category Qualification Rejection
If your application is rejected, you will receive a message explaining the reason. Most rejections are due to missing documentation. Review this document to make sure you have met all requirements. You can view your rejection message by:
Clicking the bell icon at the top of your Seller Center homepage to go to your inbox