TikTok Shop US Updates Medical Device Sales Requirements
TikTok Shop US updated its rules for selling medical devices and medical supplies. Some products require review and qualification documents, while violations may result in listing removal or penalty points.
What are the key facts?
- 1Updated US-store medical device and medical supply sales requirements
- 2Some medical devices require category qualification review
- 3Sellers may need to submit qualifications, test reports, or certificates
- 4Some medical products may be prohibited
- 5Violations may lead to listing removal, penalty points, or withdrawal of selling privileges
What happened?
TikTok Shop US Seller University updated its “Medical Devices and Medical Supplies Requirements.” The requirements apply to sellers offering medical devices and medical supplies on TikTok Shop US, including sellers whose product descriptions, advertising, or usage scenarios could cause beauty tools, health products, or sports-support products to be classified as medical devices.
Class I and Class II medical devices generally require category qualification review and the submission of genuine, complete, and unaltered qualifications, test reports, or certificates. Class III devices, prescription products, products intended solely for use by medical professionals, and products requiring approval but lacking FDA 510(k), De Novo, or PMA approval may be prohibited.
Products subject to recalls or warning letters, as well as expired, refurbished, or non-original-packaging products, may also be prohibited. Certain blood glucose monitors, blood pressure monitors, pregnancy tests, contraceptive products, and breast pumps are invite-only or require additional documents.
The platform may require sellers to provide supplementary documents and may take measures including deducting the Account Health Rating, removing listings, withdrawing selling privileges, issuing refunds, and even reporting sellers to regulatory authorities.
What does this mean for cross-border sellers?
Selling medical devices, medical supplies, or products that may be classified as medical devices based on their descriptions, advertising, or usage scenarios is subject to stricter qualification and document reviews in the US store. Sellers unable to provide genuine, complete qualifications or offering restricted products may face listing removal, penalty points, refunds, and withdrawal of selling privileges.
What should sellers do now?
- 1This week, review US-store medical devices, medical supplies, and beauty tools, health products, and sports-support products with medical claims one by one. Create a risk list and label each product category. Completion standard: every relevant listing has a review conclusion, risk reason, and disposition.Listing character checker
- 2For US-store Class I and Class II medical devices, create a qualification, test-report, or certificate file for each listing and verify that the documents are genuine, complete, and unaltered. Completion standard: every relevant product has a traceable document checklist and missing-item status.
- 3Immediately review US-store Class III devices, prescription products, professional-use products, and products requiring approval but lacking FDA 510(k), De Novo, or PMA approval. Pause high-risk listings and record the results. Completion standard: create a list of listings to remove or hold pending additional documents.
- 4Check listings for blood glucose monitors, blood pressure monitors, pregnancy tests, contraceptive products, and breast pumps to confirm whether they are invite-only and whether additional documents are required. Completion standard: each product has a qualification status, documentation gap, and submission record.