Class the device, then register/file — ‘wellness gadget’ branding does not defeat NMPA if it is a medical device.
Medical devices in China are classified and generally require filing or registration with NMPA before market entry, with local agents for overseas manufacturers. Distribution and advertising are heavily regulated overlays. This wiki orients registration. Live medical-device distribution/import and advertising guides remain deep links — we. them. Product liability and recalls apply after incidents. Cosmetics is a separate regulated category.
4 questions before you choose the route.
This page identifies the right question and evidence. It does not determine the legal outcome on a reader’s facts.
Is it a medical device under China rules?
Classification.
ClassFiling vs registration path?
Pathway.
PathChina agent appointed?
Local role.
AgentAdvertising planned?
Ads overlay.
AdsWorking rule: Map the regulated role before marketing or launch in China.
The signal ledger.
These facts move the question beyond a label and into a product, money-flow and control analysis.
Bring a compact evidence docket—not a pitch deck.
Give a compliance team or counsel the operating facts that reveal the perimeter.
Questions people ask before they build.
Short answers for orientation. The right result can change with the service model and current rules.
Are software apps devices?
SaMD-style analysis may apply. Classify carefully.
Where is device advertising deep page?
Primary authorities
Reviewed sources support orientation, not a fact-specific assessment.