Summary
Updated the Medical Devices and Medical Supplies Requirements document with a new effective date and minor editorial changes; no substantive changes to seller documentation or qualification requirements were made.
Why it matters
Sellers must comply with the updated policy version to maintain eligibility to sell medical devices and supplies, but since requirements remain unchanged, there is minimal new risk or operational impact.
Recommended action
Review the updated policy to confirm continued compliance with documentation and qualification processes; no immediate changes to seller practices are required.
Medical Devices and Medical Supplies Requirements 05/21/2026 Key Points: To sell Medical Devices and Medical Supplies, you may be required to submit documentation for review through the Qualification Center.
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: Proof of FDA Establishment Registration & Device Listing Manufacturers, importers, and repackers are required to submit proof of FDA Establishment
Medical Devices and Medical Supplies Requirements 05/21/2026 Key Points: To sell Medical Devices and Medical Supplies, you may be required to submit documentation for review through the Qualification Center.
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: Proof of FDA Establishment Registration & Device Listing Manufacturers, importers, and repackers are required to submit proof of FDA Establishment Registration and
Affects: Seller, Listing
The following documents must be provided: A screenshot of the FDA Establishment Registration number (21 CFR Part 807) from the FURLSA screenshot of the FDA Device Listing (21 CFR Part 807) from FURLSEach 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) format510(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 Tik Tok Shop.
This includes the 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.
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: 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)Tik Tok 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.
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: 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.
The following documents must be provided: A screenshot of the FDA Establishment Registration number (21 CFR Part 807) from the FURLSA screenshot of the FDA Device Listing (21 CFR Part 807) from FURLSEach 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) format510(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 Tik Tok Shop.
The following documents must be provided: A screenshot of the FDA Establishment Registration number (21 CFR Part 807) from the FURLSA screenshot of the FDA Device Listing (21 CFR Part 807) from FURLSEach 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) format510(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 Tik Tok Shop.
This includes the 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.
This includes the 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.
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: 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)Tik Tok 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.
This includes the 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.
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.