Policy AdvisorPolicyTikTok Source

Medical Devices and Medical Supplies Requirements

Captured: TikTok page date: Hash: bd09259ee594

Creator TL;DR

AI-generated from the captured TikTok policy text. Verify against the TikTok source before acting.

TikTok Shop says medical devices and medical supplies are tightly controlled. Sellers may need category qualification and additional product-specific documentation, depending on seller type and the item. Some products are prohibited, some are invite-only, and some require documentation uploaded at listing time. Sellers should verify the TikTok source and also check the Restricted Products Policy before listing.

Key points

  • Medical devices are defined by intended use, not by the category the seller selects.
  • Some medical devices and supplies are prohibited from TikTok Shop.
  • Some products are invite-only and only approved invite-only sellers may offer them.
  • Some products require category qualification through the Qualification Center.
  • Some products require product-specific documents uploaded during Product Listing, not through Category Qualification.
  • TikTok may request additional information and may enforce penalties for violations.

Say / show

  • Check whether the product’s claims or intended use make it a medical device.
  • Use the Qualification Center for category qualification when required.
  • Upload authentic, unmodified documents in the required format.
  • Use Seller Center Product Compliance for product-specific documentation when required.
  • Review rejection reasons and resubmit with corrected documents.
  • Verify requirements against the TikTok source before acting.

Do not say / show

  • Do not assume a product is allowed just because it is labeled as beauty, wellness, sports, or consumer gadget.
  • Do not list prohibited medical devices, including the examples named in the source.
  • Do not submit designated-product documents through the Qualification Center when the source says to upload them during Product Listing.
  • Do not use the FDA logo in product images or listings.
  • Do not claim electrical safety without approved testing or certification.

Violation risks

  • Product removal
  • Warning
  • Deducted Account Health Rating points
  • Loss of permission to offer products for sale
  • Customer refunds
  • Account suspension
  • Possible reporting to legal authorities

Who it affects

  • Sellers of medical devices and medical supplies
  • Manufacturers, importers, and repackers
  • Resellers
  • Invite-only sellers
  • Sellers of designated products such as pacifiers, baby sunglasses, nebulizers, and hearing aids

Source notes

  • This summary is based only on the provided TikTok source text.
  • The source says to review the Restricted Products Policy as well.
  • The source says sellers are responsible for compliance with applicable laws and should consult legal counsel for specific obligations.
  • Requirements vary by seller type and product, so verify the TikTok source before listing or submitting documentation.

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: article-html.

Key Points:
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.
This policy is provided for informational purposes to help sellers understand TikTok Shop's requirements. It is not legal advice and does not create any additional legal obligation beyond applicable law. Sellers are solely responsible for complying with all applicable federal, state, and local laws and regulations, including any changes to those laws or regulations after publication of this policy, and should consult their own legal counsel with questions about their specific obligations.

Medical Devices and Medical Supplies

Medical devices are regulated by the US Food and Drug Administration (FDA). Whether a product is a medical device under US law depends on its intended use, including what the product is designed, labeled, advertised, or promoted to do — not the product category selected by the seller.
For example, products marketed as 'beauty tools,' 'wellness products,' 'sports accessories,' or 'consumer gadget' may be treated as a medical device when their claims or intended use indicate that they diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body.
Products intended only for cosmetic appearance, general wellness, or ordinary sporting use may not be medical devices unless their claims or intended use cross this threshold.
Products intended only for cosmetic appearance, general wellness, or ordinary sporting use may not be medical devices unless their claims or intended use cross this threshold. More information about determining what a medical device is may be found here: FDA guidance.

Medical-Device Classifications

ClassificationExamplesTikTok Shop Eligibility
Class ISubject to general controls. Most, but not all, are exempt from 510(k) premarket notification.
Bandages
Tongue depressors
Examination gloves
Eligible with category qualification*
Class IISubject to general and special controls. Most require 510(k) clearance, although some are exempt.
Thermometers
Blood pressure monitors
Surgical masks
Eligible with category qualification*
Class IIIInvolved in life-support and/or life-sustaining efforts, and/or products/devices that are implanted, and typically require Premarket Approval (PMA).
Pacemakers
Implantable defibrillators
Heart valves
Breast implants
Prohibited for sale on TikTok Shop.
*All prescription products and professional-use only products are prohibited. See Prohibited Products Policy.

Prohibited Products

Products that are not permitted on TikTok Shop include, but are not limited to:
  • Class III medical devices
  • Products that require a prescription issued by a licensed healthcare provider
  • Products designed, labeled, or intended for use only by healthcare professionals in a healthcare setting. A device may fall under this prohibition even if it does not require a prescription
  • Accessories to prescription or professional-use-only devices, where the accessory itself requires a prescription or is intended solely for professional healthcare use
  • Class I, II, or III devices that are required to be cleared or approved by the FDA but have not received the required 510(k) clearance, De Novo authorization, or Premarket Approval (PMA), and are not exempt
  • Medical devices that are adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act), or that otherwise fail to comply with the FD&C Act and the FDA's implementing regulations and guidance
  • Devices marketed, described, or listed for a use beyond the FDA-cleared or FDA-approved intended use for the product's classification
  • Devices that are used, refurbished, or not in their original, unopened retail packaging
  • Devices not manufactured in an FDA-registered facility, or not listed with the FDA
  • Devices that are the subject of regulatory action or other FDA enforcement, including devices named in FDA Recalls, Market Withdrawals, & Safety Alerts, and devices identified in — or manufactured at a facility identified in — an FDA Warning Letter
  • Autonomous or robotic systems intended to independently perform clinical care, patient monitoring, rehabilitation, patient transfer, or mobility assistance
  • Devices that are past their labeled expiration or “use by” date, where the device bears such a date
  • Devices labeled “tester,” “demonstration unit,” “not for retail sale,” or “not intended for resale”
  • Unauthorized use of the FDA logo in product images or listings. The FDA logo is reserved for official U.S. government use; use by sellers implies FDA endorsement and is prohibited.
The following are generally permitted for sale on the platform unless their claims, functionality, or intended use make them medical devices:
  • Standard baby pacifiers and teethers
  • Hiking sticks and recreational walking poles
  • General fitness braces, sleeves, and supports
  • Cosmetic facial and hair-removal tools
  • General-wellness massage products
  • Non-prescription eyewear cases and similar accessories
For example, a hiking pole marketed for balance during hiking is sporting equipment. The same product marketed to compensate for impaired mobility or assist rehabilitation may be treated as a medical device.
For more information, please see FDA's website here: FDA guidance.

Invite-Only Medical Devices

Only approved invite-only sellers may offer:
Diagnostics and Home Monitoring
  • Blood glucose monitors and test kits
  • Glucose control solutions
  • Electric or manual blood-pressure monitors
  • Cholesterol monitors
Reproductive and Sexual Health
  • Fertility thermometers
  • Ovulation and fertility test kits
  • Pregnancy tests
  • Male and female fertility tests
  • Male and female condoms
  • Personal lubricants regulated as medical devices
These products are only available to invite-only sellers and have additional requirements/best practices. See Promoting Sexual Wellness Products for more information.
Baby and 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.

Requirements To Sell Medical Devices and Medical Supplies Class I and II

Sellers must pass category qualification to sell Medical Devices and Medical Supplies. This process requires submitting documents proving a seller is qualified to sell these products.
All documents, test reports, and certificates submitted to TikTok Shop must be authentic and provided in their original, unmodified format (for example, PDF or JPEG). TikTok Shop reserves the right to request additional information at any time.

Manufacturers, Importers, And Repackers

To sell Medical Devices and Medical Supplies Class I and II, manufacturers, importers, and repackers are required to submit the following documents:

Proof of FDA Establishment Registration and Device Listing

  • A screenshot of FDA Establishment Registration number (21 CFR Part 807) from FURLS
  • A screenshot of 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)
  • 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

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:
  • Must show all sides of the product and packaging
  • Must be in full color (no black and white)
  • Must NOT be angled, blurry, cropped, or edited/altered
  • Must have a minimum resolution of 600 × 600 pixels
  • Must reflect the product listed on related documents
  • Must be clear, legible, complete, and unedited
  • Where a Unique Device Identifier (UDI) is required, it must be visible on the label; Class I devices sold at retail that already bear a UPC may be excepted from certain UDI requirements (21 CFR Part 830).
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
  • Unique Device Identifier (UDI), in both human-readable and automatic identification and data capture (AIDC) form, as required under 21 CFR Part 830 and 21 CFR Part 801 Subpart B
  • Required on-label markings, including any mandatory caution or warning statements and the prescription-only (“Rx only”) legend under 21 CFR 801.109 where the device is prescription-restricted.
  • Intended use
Images must meet the following requirements:
  • Must show all sides of the product and packaging
  • Must be in full color (no black and white)
  • Must NOT be angled, blurry, cropped, or edited/altered
  • Must have a minimum resolution of 600 × 600 pixels
  • Must reflect the product listed on related documents
  • Must be clear, legible, complete, and unedited
  • Set or bundle: Must include images of each individual item
Documentation must meet the following requirements
  • Must reflect the product listed on related documents (this may include FDA documentation or invoices)
  • Must be clear, legible, complete, and unedited
  • Must be provided in the language of the intended country of sale (including product instructions, manuals, safety information, labels, and warnings)

Resellers

To sell Medical Devices and Medical Supplies Class I and II, resellers must 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 (The 400-unit minimum demonstrates an established supply-chain relationship and sufficient inventory commitment. It applies to the combined purchase shown on the submitted invoice.)
  • 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:
  • Must show all sides of the product and packaging
  • Must clearly and legibly show product description, warning logos, and any other required information
  • Must be in full color (no black and white)
  • Must NOT be angled, blurry, cropped, or edited/altered
  • Must have a minimum resolution of 600 × 600 pixels
  • Must reflect the product listed on related documents
  • Must be clear, legible, complete, and unedited
  • Where a Unique Device Identifier (UDI) is required, it must be visible on the label; Class I devices sold at retail that already bear a UPC may be excepted from certain UDI requirements (21 CFR Part 830).
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
  • Unique Device Identifier (UDI), in both human-readable and automatic identification and data capture (AIDC) form, as required under 21 CFR Part 830 and 21 CFR Part 801 Subpart B
  • Required on-label markings, including any mandatory caution or warning statements and the prescription-only (“Rx only”) legend under 21 CFR 801.109 where the device is prescription-restricted
  • Intended use
Images must meet the following requirements:
  • Must be in full color (no black and white)
  • Must NOT be angled, blurry, cropped, or edited/altered
  • Must reflect the product listed on related documents
  • Must be clear, legible, complete, and unedited
  • Set or bundle: Must include images of each individual item
Documentation must meet the following requirements
  • Must reflect the product listed on related documents (this may include FDA documentation or invoices)
  • Must be clear, legible, complete, and unedited
  • Must be provided in the language of the intended country of sale (including product instructions, manuals, safety information, labels, and warnings)

Additional Requirements

These requirements are in addition to the documentation required for each seller type above.

Electrical Medical Devices

For Manufacturers or Importers
  • A valid Certification of Compliance/Conformity (COC) issued by an Occupational Safety and Health Administration (OSHA) recognized Nationally Recognized Testing Laboratory (NRTL) — for example, UL, Intertek/ETL, CSA, or TÜV Süd. 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:
  • 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 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 Documentation

For the specific products listed above, sellers must submit the appropriate safety documentation. All documentation must match the product exactly.
Children's Product Certificate (CPC) and Lab Test Reports
(For Pacifiers, Teethers, Dummies, and Baby Sunglasses)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)Required product-specific safety testing documentation or clearance required by the FDA or relevant governing body for these specific devices.
    NOTE: Required documentation for these desginated products must be uploaded directly during the Product Listing process. This includes the CPC, Lab Test Report, or specific device testing. The listing will remain under review until the product-specific documents are verified.
    Documentation for these products should not be submitted through the Category Qualification Center.

    Electrical Safety Claims

    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.

    Enforcement Actions and Appeals

    TikTok Shop regularly reviews sellers' shops for compliance with platform policies. If any violations are identified, TikTok Shop may take enforcement action at its sole discretion.
    The severity of the enforcement action may depend on factors such as the type of violation, its impact on user safety, the seller's violation history, and the intent behind non-compliance. For example, a first-time, unintentional listing of a restricted item might result in a warning and product removal, whereas repeated or intentional violations involving unsafe products could lead to account suspension. This may include, but is not limited to:
    • Deducting points from Account Health Rating (a platform metric that measures a seller's performance and policy compliance)
    • Removing product listings
    • Revoking access to offer products for sale
    • Issuing refunds to customers
    TikTok Shop reserves the right to report sellers who violate applicable laws or regulations to the appropriate legal authorities where appropriate.Sellers should note that some products that are legally sold in their local area, state, or country may still be prohibited under TikTok Shop policies.For more information on enforcement actions, see Seller Enforcement Policy. For appeals, see 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:
    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 Over-the-Counter (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, and so on.
    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 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
    • 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 is needed.
    4. Update or replace your documentation to meet the category’s requirements.
    5. Click Resubmit to submit your revised application.

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