Purpose and Scope

This TikTok Shop Medical Devices Policy (the "Policy") outlines the requirements sellers must follow when listing permitted medical devices and medical supplies on TikTok Shop. This policy supplements TikTok's Community Guidelines, Seller Terms of Service, and TikTok Shop Business Partner Code of Conduct (collectively, "TikTok Terms").

This policy is not intended as legal advice. For any questions regarding US laws and regulations, we encourage all users to seek independent legal advice.

This policy is updated periodically. Sellers must check this document regularly to ensure compliance with our current policy. TikTok Shop reserves the right to make changes to any policy at any time without prior notice. Please review our TikTok Shop Policy Center on TikTok Shop Academy for the most up-to-date policies.

Policy Statements

All TikTok Shop sellers are required to comply with this policy. Please note that some products that are legal to sell in their locale, state, or country may still be prohibited under TikTok Shop policies.

Medical Devices

The sale of products that are classified as medical devices is subject to restriction. The FDA regulates medical devices, and certain types of products may also fall into different classifications depending on their intended use. Certain classes (Class III) and types of medical devices are prohibited on TikTok Shop.
Sellers are responsible for identifying if their product is a medical device and the relevant classification, which can be done by clicking here. Sellers should seek independent advice if they have questions about product classification.

Category Qualification Requirements

Sellers must pass a category qualification process before listing permitted medical devices. To pass the category qualification process, sellers must submit documentation based on the type of product and whether the seller is a manufacturer/importer or reseller.
Certain high-risk medical devices are restricted to select qualified sellers and may require product-level documentation. Please review the specific requirements under Product Qualification.

Medical Devices Class I and II

Resellers must submit the following:

• Purchase invoice
• Sample product label
• If the medical device is electrical:
  • Image of valid Product Electrical Safety Marking
  • Image of valid Product FCC Safety Marking (if the product has Bluetooth or Wi-Fi)

Manufacturers and importers must submit the following:

• Proof of FDA Establishment Registration & Device Listing
• 510(K) Pre-Market Notification or Proof of Exemption (Class II only)
• Sample product label
• If the medical device is electrical:
  • Certification or registration of Compliance / Conformity (COC)
  • Image of valid Product Electrical Safety Marking
  • Image of valid Product FCC Safety Marking (if the product has Bluetooth or Wi-Fi)

In addition to the above requirements, manufacturers, resellers, and importers must be invited by TikTok Shop before they can sell certain medical devices. These include Ear Drops, Eye Drops, Contact Lens Solutions, and Contact Lens Conditioning Kits.

Medical Masks (Surgical N95 Respirators and PPE Masks)

Resellers must submit the following:

• Purchase invoice
• Sample product label

Manufacturers and importers must submit the following:

• Proof of FDA Establishment Registration & Device Listing
• 510(K) Pre-Market Notification or Proof of Exemption (Class II only)
• Sample product label

For more details about this product category and the required documents, read our Documents Required To Sell Medical Devices and Medical Supplies article. Sellers who wish to obtain category qualification to sell medical devices are also required to comply with any additional requirements found in the aforementioned article. Please note that certain product categories may have additional product-specific requirements that must be met prior to completing the listing process.
Compliance with TikTok Shop policies is required. TikTok Shop reserves the right to review an approved seller or creator account and any related documents to the account at any time.
TikTok Shop monitors compliance through a wide range of business tools, including but not limited to internal and external audits, in-app reporting, and algorithmic detection. TikTok Shop may review and audit product information at any time. Additional audits may be performed to identify if any change in listing information violates our policy above.

Non-Compliance

It is at the sole discretion of TikTok Shop to determine when sellers are in violation of this policy and subsequently to take appropriate enforcement actions, including but not limited to, rejecting the seller's category qualification application, points and removal of product listings.
Non-compliance with this policy, including but not limited to, attempts to circumvent the stated policy/process by bypassing or knowingly manipulating the process, system, or data, may result in enforcement actions, as set forth in TikTok Shop's Seller Enforcement Policy and/or the TikTok Shop Creator Performance Evaluation Policy. Products that are found to violate our Seller Performance Evaluation Policy and our TikTok Shop Product Listing Policy may be removed from TikTok Shop.
TikTok Shop may temporarily or permanently suspend or remove the selling privileges of sellers who commit severe or repeated violations of this policy. We reserve the right to report sellers who violate local laws and regulations to the necessary legal authorities where appropriate.