Medical Devices and Medical Supplies Policy

12/30/2025

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 policy outlines the requirements you may need to meet in order to sell Medical Devices and Medical Supplies on TikTok Shop.

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. 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
- Ear and nose care
- Sunglasses
- Breast pumps and accessories

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

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
Fashion Accessories
- Sunglasses
- Replacement lenses
- Non-prescription glasses
Sports & Outdoor
- Hiking sticks
- Walking poles
- Cycling and fishing glasses
- Sunglasses
- Golf and skiing sunglasses
- Sports eyewear
- Sports sleeves and support
- First aid kits
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:

1. 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

2. 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

3. Product Label Images

Class I Medical DevicesManufacturers, 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 DevicesClass 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:

1. 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

2. Product Label Images

Class I Medical DevicesResellers 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 DevicesClass 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 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 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

Over the Counter (OTC) Medication Requirements (Invite Only)

This section details the requirements that invite-only sellers must follow when selling Over-the-Counter (OTC) medications on TikTok Shop. Sellers who are not invited to sell OTC medication are prohibited from selling them.

The following products may be offered by invited sellers:

Antifungals
- Yeast infection treatments
- Thrush treatments
- Acne treatments
- Nasal treatments
- Nail fungus treatments
- Jock itch treatments
- Dandruff treatments
- Athlete’s foot treatments
Scars & Stretchmarks
- Stretchmark removal creams, gels, lotions, and oils
- Scar tapes or patches
Allergies, Sinus & Asthma
- Allergy relief products
- Sinus congestion treatments
- Asthma management products
Pain Relief
- Acetaminophen and ibuprofen
- Muscle stimulators and accessories
- Joint or muscle pain relief rubs or medications
- Homeopathic remedies
Eczema, Psoriasis & Rosacea Care
- Topical creams or treatments for eczema, psoriasis, or rosacea
Cuts & Wounds
- Products that support healing for cuts and wounds
Digestion & Nausea
- Products that relieve digestive discomfort or nausea
Coughs & Colds
- Products that relieve cough or cold symptoms

Manufacturers, Importers, and Repackers

General Certificate of Conformity (GCC)

Manufacturers, importers, and repackers must provide a General Certificate of Conformity (GCC) that includes:

Product description: A clear and specific description of the product covered by the GCC.
Applicable product safety rules: List all relevant safety rules, including:
- Compliance with 21 CFR Part 73 Subpart B – Drugs (approved color additives permitted in OTC medications)
Testing details: Date(s) and location where the product was tested for each consumer product safety rule listed.
Certifying party information: Name, full mailing address, and telephone number of the U.S. domestic manufacturer or importer certifying the product.
Record keeper information: Name, full mailing address, email address, and telephone number of the person responsible for maintaining test records.
Manufacturing details:
- Month and year of manufacture
- Country, and if applicable, state and city/administrative region where the product was manufactured or assembled
- If multiple facilities are in the same city, include the specific street address of the manufacturing location

Product Lab Test Report

Manufacturers, importers, and repackers must submit at least one valid product lab test report from an approved laboratory.

Accepted Test Report TypesThe test report must be one of the following:

A valid test report from TikTok Shop Accredited Partner Laboratories (listed below); or
A valid test report from an in-house ISO/IEC 17025–accredited laboratory, plus a valid ISO certificate; or
A valid test report from an in-house laboratory, plus a valid cGMP certificate compliant with 21 CFR 111 or 21 CFR 117.

TikTok Shop Accredited Partner LaboratoriesAccepted partner laboratories include:

Test Report RequirementsAll submitted test reports must meet all of the following:

Issued within the last 180 days
Cover products that match the purchase invoice, including brand and manufacturer details
Display the same company name and address as the selling account
- If the seller is the manufacturer, the manufacturer listed on the report must match the selling account

Required Test ContentA valid test report must include:

Microbiological testing
Heavy metals testing
Contaminant testing, such as pesticides or residual solvents (as labeled on the report)
Content claims / potency / label claim verification
- The reported amount of each active ingredient per dosage unit must fall within the permitted tolerance range

Resellers

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 Lab Test Report

Resellers must submit at least one valid product lab test report from an approved laboratory.Accepted Test Report TypesThe test report must be issued by a TikTok Shop Accredited Partner Laboratory, including:

Test Report RequirementsAll submitted test reports must meet all of the following:

Issued within the last 180 days
Cover products that match the purchase invoice, including brand and manufacturer details
Display the same company name and address as the selling account
- If the seller is the manufacturer, the manufacturer listed on the report must match the selling account

Required Test ContentA valid test report must include:

Microbiological testing
Heavy metals testing
Contaminant testing, such as pesticides or residual solvents (as labeled on the report)
Content claims / potency / label claim verification
- The reported amount of each active ingredient per dosage unit must fall within the permitted tolerance range

Enforcement Actions and Appeals

Claiming electrical safety without approved testing or certification violates this policy. 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 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 . If you'd like to appeal an enforcement action, visit the section.

How to Submit Your Documentation

For categories under category qualification, submit your documentation via the Qualification Center in Seller Center. Click 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 OTC products. To submit product-specific documentation:

Log into Seller Center.
Select Products > Add Products.
Select Add product. Begin entering your product information, category, images, description, details, etc.
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’ll receive a message explaining the reason. Most rejections are due to missing documentation. Review this policy 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:

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

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