Post-market Compliance

What Should You Do When an E-Commerce Platform Requests Proof That a Product Is Non-Medical?

First identify the exact SKU, model, page and claim being questioned. Submit a package consistent with the product actually sold rather than relying on a single result for another version.

During listing, review or complaint handling, an e-commerce platform may request “proof that the product is not a medical device.” This commercial phrase does not always refer to one statutory document. The company should first understand what the platform is checking.

1. Clarify the exact question

The platform may be concerned about the product name, claims, category, missing licence or a particular complaint. Obtain the complete notice and identify the SKU, model, page and sales period. Do not reduce every issue to “one missing certificate.”

2. Prepare a product evidence package

  • Company and manufacturer identity.
  • Photos and identity of the sold model.
  • Instructions and key output parameters.
  • Classification result or professional status explanation.
  • Test and quality documents.
  • Purpose and claim explanation.
  • Model-difference and version-consistency statement.

3. Match the result to the SKU

If the sold device adds a handpiece, raises a level, changes the App or uses another model, an earlier result may not apply. Check every function displayed on the product page against the assessed product definition.

4. Correct inconsistent claims

If the problem comes from treatment, repair, inflammation, pain or rehabilitation claims, uploading a classification result without correcting the page will not solve the underlying issue. Review livestreams, Q&A, customer-service scripts and distributor materials.

5. Maintain a long-term file

For each SKU, keep a ready package containing model, output, instructions, tests, classification basis, page version and review history. Review new functions and content before release and keep all communications.

Platform requirements can change. Follow the specific notice, preserve the communication record and ensure the evidence corresponds to the product actually sold.
This article provides general compliance information and cannot replace a formal assessment of a specific product. Regulations, classification catalogues, guidance, and enforcement practice may change; each project should rely on the rules then in effect, the actual product, and formal documents.
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