Key Points:

• To sell Medical Devices and Medical Supplies, you may be required to submit documentation for review through the Qualification Center. Requirements vary depending on whether you are the product’s manufacturer, importer, repacker, or reseller.
• To better understand the category review process and how to respond to rejections, refer to Your Guide to Category Qualification.

This document outlines the requirements for selling Medical Devices and Medical Supplies on TikTok Shop. 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.

1. Baby & Maternity
   • Pacifiers, teethers, teething relief, and dental care
   • Ear and nose care
   • Sunglasses
   • Breast pumps and accessories

• These products require additional documentation. For more information, see Baby and Maternity Products Requirements.

2. Beauty & Personal Care
   • Ice packs
   • Heat patches
   • Facial beauty devices
   • Hair removal devices
   • Earwax removal tools
   • Massage tools
   • Toothbrushes
   • Teeth whitening devices
   • Denture care
   • Dental floss and picks
   • Tampons
   • Menstrual cups and pads
   • Sanitary tools
   • Reading glasses
   • Glasses Cases
   • Contact lens applicators
3. Fashion Accessories
   • Sunglasses
   • Replacement lenses
   • Non-prescription glasses
4. Sports & Outdoor
   • Hiking sticks
   • Walking poles
   • Cycling and fishing glasses
   • Sunglasses
   • Golf and skiing sunglasses
   • Sports eyewear
   • Sports sleeves and support
   • First aid kits
5. Health
   • Thermometers
   • Pressure monitors
   • Home test kits
   • 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

• A valid Certification of Compliance/Conformity (COC) accredited by 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)

• Image of a valid Product Electrical Safety Marking
• Image of a valid Product 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
  • 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:

• Packaging Label:
  • ASTM F2100 or EN 14683 standard on the box label
  • Expiration date / Use by date

Ear Drops, Eye Drops, Contact Lens Solutions, and Contact Lens Conditioning Kits

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.

1. Children's Product Certificate (CPC) and Lab Test Reports

(For Pacifiers, Teethers, Dummies, and Baby Sunglasses)You must provide a valid CPC and a 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 CPSIA Section 108 for Phthalates and 16 CFR 1501 for Small Parts). TikTok Shop must not be listed as the importer or responsible party.

2. 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 CPC, Lab Test Report, or specific device testing directly during the Product Listing process. 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.

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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:

1. Log into your Seller Center account.
2. Click your shop icon in the top right corner.
3. Go to My Account > Account Settings.
4. Select Qualification Center.
5. Click on Category Qualification.
6. 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 OTC products. To submit product-specific documentation:

1. Log into Seller Center.
2. Select Products > Add Products.
3. Select Add product. Begin entering your product information, category, images, description, details, etc.
4. Fill out the Product Compliance section and submit your documents.
5. 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’ll receive a message explaining the reason. Most rejections are due to missing documentation. Review this document to make sure you’ve 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
• Opening the rejected application in the Qualification Center.

To re-apply:

1. Go to the Qualification Center, then click Category Qualification.
2. Click the rejected category to view the rejection reason.
3. Review the related category requirements to confirm what’s needed
4. Update or replace your documentation to meet the category’s requirements.
5. Click Resubmit to submit your revised application.