CHINA — SAMR REGISTRATION & CROSS-BORDER E-COMMERCE
General trade requires a registered or filed health food product with Chinese labelling and in-country testing. Cross-border e-commerce lets a foreign-label product reach Chinese consumers without registration, but only within the positive list and only for personal use. Choosing the wrong door costs a year.
THE TWO ROUTES
Registration and cross-border are different products, not different paperwork.
A product entering China through general trade is a Chinese product. It carries a Chinese label, a Chinese-registered legal agent, in-country testing, and either a health food registration approval — the Blue Hat — or a filing record for a small set of well-characterised nutrients. A product entering through cross-border e-commerce stays a foreign product: it keeps its home label, ships from a bonded warehouse or direct from overseas, and is limited to what appears on the cross-border positive list. Kompete determines which route your formula and commercial plan can actually support, then builds the dossier for that route only.
GENERAL TRADE
The Blue Hat is a licence, not a certificate.
Health food registration with the State Administration for Market Regulation grants a specific product, with a specific formula, a specific claim from the approved function list. Change the excipient, the dose, or the delivery format and you are amending an approval. Timelines run long and the review is technical, so the formula has to be designed for the file rather than adapted to it afterwards.
WHAT EACH ROUTE DEMANDS
Four decisions that set your Chinese timeline.
Health food registration
Required for approved-function claims. Product-specific dossier, in-country testing, and a Chinese legal agent holding the approval.
Filing (record-keeping)
A faster route limited to vitamins, minerals, and other listed raw materials at defined dose ranges. Formula freedom is traded for speed.
Cross-border e-commerce
No registration, foreign label retained, positive-list ingredients only. Sales are personal-use and cannot be supported by domestic retail distribution.
Ingredient eligibility
Novel food status, botanical permissions, and prohibited actives are screened first. An ineligible ingredient ends the route before any dossier work begins.
LABELLING & TESTING
Nothing reaches a shelf without in-country data.
General trade products carry a full Chinese-language label with declared nutrient content, the approved claim wording, a domestic responsible party, and the registration or filing number. Verification testing is performed by accredited Chinese laboratories, and results that disagree with your certificate of analysis stop the file. We align specification, method, and overage before samples are shipped, so the Chinese result matches the one you already hold.
HOW WE HELP
A route decision, then a dossier built only for that route.
Eligibility screen
Every active checked against the health food raw material list, the cross-border positive list, and novel food status.
Dossier and agent
Technical file assembly, testing protocol, Chinese label copy, and coordination with the domestic entity holding your approval.
Cross-market reuse
Documentation structured so the same evidence supports Japan, Korea, and Australian filings without being rebuilt.
Decide the Chinese route before the formula is locked.
We will tell you which door your product can walk through, what it will cost in time, and what has to change in the formula to keep both options open.