Two Different Questions
A product-status determination addresses whether the product is regulated as a medical device. Advertising law, unfair-competition rules, e-commerce platform policies and consumer protection govern how the product may be promoted and sold.
High-risk Scenarios
- Distributors add treatment or disease-related claims without approval
- Trainers present non-medical aesthetic devices as medical procedures
- E-commerce pages use before-and-after comparisons or unsupported efficacy data
- Livestreams use implications, cases or testimonials to avoid written-content review
Companies need unified materials, review procedures and distributor-responsibility controls.
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.