Tiktok Shop Academy

Medical Devices and Medical Supplies Policy

11/12/2025

image
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 FDA-regulated and classified based on their intended use. To determine if your product qualifies as a medical device and to identify its classification, click here. The following categories may include products considered medical devices:
  1. Baby & Maternity
(Pacifiers, teethers, teething relief, sunglasses, dental care, ear and nose care, breast pumps and accessories, etc.)
These products require additional documentation, including a Children’s Product Certificate (CPC), a test report from a Consumer Product Safety Commission (CPSC) accredited laboratory, and a sample tracking label. For more information, refer to the Baby and Maternity Products Policy.
  1. Beauty & Personal Care
(Ice packs, heat patches, facial beauty devices, hair removal devices, toothbrushes, teeth whitening devices, denture care, dental floss and picks, tampons, menstrual cups, sanitary towels, earwax removal products, glasses cases, contact lens handlers (applicators), reading glasses, massage tools, etc.)
  1. Fashion Accessories
(Sunglasses, replacement lenses, non-prescription glasses, etc.)
  1. Health
(Thermometers, medical masks, PPE masks, pressure monitors, home test kits, etc.)
  • Certain high-risk health products are only permitted on TikTok Shop through an invite-only process, including glucose monitors, electric and manual blood pressure monitors, cholesterol monitors, glucose control solutions, and glucose kits.
  1. Sports & Outdoor
(Hiking sticks, cycling glasses, fishing glasses, walking poles, sports eyewear, sports sleeves and support, golf sunglasses, First Aid Kits, skiing sunglasses, etc.)

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 a category qualification process to sell Medical Devices and Medical Supplies on our platform. This process involves submitting documentation that shows you are qualified to sell in this category.
Detailed requirements are outlined in collapsible sections below. Please expand each section to view the necessary information.

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 Listingimage
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 FDA Unified Registration and Listing System (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 clearly 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, including product description and details
Additional requirements:
  • All documents must be authentic and remain in their original (unmodified) format
3. Product Label Imagesimage
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, 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 accurately reflect the product listed on related documents such as 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 Purchaseimage
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 Imagesimage
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 accurately reflect the product listed on related documents such as 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 (Manufacturers, Importers, and Repackers OR Resellers).
Open each section below to see the specific requirements for different types of medical devices.

Electrical Medical Devices

image
image
For Manufacturers or Importers:
For Resellers:
  • 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

image
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)

image
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)
image
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 — products used for yeast infections, thrush, acne treatment, nasal treatment, nail fungus, jock itch, dandruff, and athlete’s foot
  • Scars & Stretchmarks — including stretchmark removal creams, gels, lotions, oils, and scar tapes or patches
  • Allergies, Sinus & Asthma — products used for allergy relief, sinus congestion, or asthma management
  • Eczema, Psoriasis & Rosacea Care — topical treatments or creams formulated for eczema, psoriasis, or rosacea
  • Pain Relief — such as acetaminophen, ibuprofen, muscle stimulators and accessories, and joint or muscle pain relief rubs or medications (including homeopathic remedies)
  • Cuts & Wounds — products that support cut and wound healing
  • Digestion & Nausea — products used to relieve digestive discomfort and nausea symptoms
  • Coughs & Colds — products used to relieve cough and cold symptoms

Manufacturers, Importers, and Repackers

  1. General Certificate of Conformity (GCC)
image
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
  1. Product Lab Test Report
Manufacturers, importers, and repackers must submit at least one lab test report from a pre-approved laboratory.
The report must meet all of the following requirements:
  • Be issued within the last 180 days
  • Show products that match those listed on the purchase invoice, including brand and manufacturer information
  • Show the same name and address as the selling account
    • If the seller is the product manufacturer, the manufacturer listed on the test report must match the selling account
  • Comply with the following regulations:
    • 16 CFR Part 1700 (Poison Prevention Packaging Act)
    • 21 CFR 207 Subpart C (National Drug Code)

Resellers

  1. Purchase Invoice or Proof of Purchase
image
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
  1. Product Lab Test Report
Resellers must submit at least one lab test report from a pre-approved laboratory.
The report must meet all of the following requirements:
  • Be issued within the last 180 days
  • Show products that match those listed on the purchase invoice, including brand and manufacturer information
  • Show the same name and address as the selling account
    • If the seller is the product manufacturer, the manufacturer listed on the test report must match the selling account
  • Comply with the following regulations:
    • 16 CFR Part 1700 (Poison Prevention Packaging Act)
    • 21 CFR 207 Subpart C (National Drug Code)

Enforcement Actions and Appeals

Products violate this policy if they claim electrical safety without proper testing or certification 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 rejecting your category qualification application, deducting points from your account health, or removing product listings. For more information on enforcement actions, refer to our Seller Enforcement Policy.
If you'd like to appeal an enforcement action, visit the Appeals section of our Seller Enforcement Policy for guidance on how to proceed.

How to Submit Your Documentation

Submit your documentation through the Qualification Center in Seller Center by clicking here or following the steps below:
  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.
image

How To Address A Category Qualification Rejection

image
If your application is rejected, you’ll receive a message explaining the reason. Most rejections are due to missing documentation. It's important to review this policy and ensure you are submitting all documentation and the requirements associated with them.
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 policy 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.
PreviousPre-Owned Products PolicyNext Shelf-Stable Food and Beverage Policy