Source record
- Jurisdiction
- China
- Issuing authority
- National Medical Products Administration
- Document status
- General guidance on cosmetic market entry
- Source review
- Source checked
Original documents
An overseas brand wants to sell cosmetics in mainland China through a conventional import and retail route. It has a formula, an EU safety file and finished artwork. What must it check before the first shipment?
The starting point is the product’s Chinese classification and the route that applies to it. China distinguishes general cosmetics from special cosmetics, and overseas filers and registrants have specific domestic-responsible-person arrangements.
This article concerns conventional mainland China import and sale of cosmetics; other channels and territories need their own review. Classification and duties depend on the actual product and claims. Sources were checked on 3 November 2026. Read the eight-market comparison for context.
This article was generated with AI and checked against the sources linked below. It has not been independently reviewed by a local regulatory professional.
Determine whether the product is general or special
China’s National Medical Products Administration (NMPA) describes filing for general cosmetics and registration for special cosmetics. The actual formula, function, target users and claims must be assessed. The presence of a particular claim or ingredient can affect the route and evidence required.
Record all names and claims intended for the Chinese label and marketing. Confirm their classification before promising a launch date or assuming that an overseas description can be translated directly. If the brand later adds sun protection or another claim, revisit the decision.
Appoint the domestic responsible person
Under the NMPA’s registration and filing provisions, an overseas registrant or filing person designates an enterprise legal person within China as the domestic responsible person. That party handles registration or filing on the overseas party’s behalf and has other specified responsibilities, including helping with adverse-reaction monitoring and product recalls.
The domestic responsible person must also cooperate with regulatory supervision and inspection and, according to its agreement with the registrant or filing person, assume corresponding quality and safety responsibilities for products released in the domestic market. The registrant or filing person remains responsible for product quality and safety and the authenticity and scientific basis of filing materials. These are related duties, not an automatic transfer of every obligation to one party. NMPA: registration and filing provisions, Articles 7–8.
Agree the role in writing and make sure the responsible person can obtain current product information. The brand, manufacturer, domestic responsible person and importer may be different organisations. Identify who controls the formula, who will supply technical records and who will respond when the authority raises a question. A contractual allocation must be read alongside the legal duties that apply to each entity.
What happens if the product or filing does not comply?
The NMPA’s filing provisions describe different responses for different circumstances. For example, if a filed dossier fails to meet requirements, the filing authority can order corrections. If filed safety information does not meet requirements, it may also order suspension of sale and use. The provisions identify circumstances in which a filing must be cancelled, including false filing documents. These are regulatory actions; whether a party faces additional administrative, civil or other liability depends on the applicable rules and facts. NMPA: filing provisions, Articles 56–59.
The NMPA’s manufacturing and marketing provisions also specify actions for registrants or filing entities when sample-testing results are non-conforming, including stopping manufacture, recalling affected products already on sale, informing marketers and consumers, and conducting an internal review and corrective action. The domestic responsible person’s duties include assisting with recall and monitoring. Agree the reporting and recall contacts before launch rather than assuming that filing alone completes those responsibilities. NMPA: manufacturing and marketing provisions, Articles 4 and 53.
Plan the filing before import
The NMPA’s provisions state that a filing person completes filing for a general cosmetic before it is marketed or imported. Special cosmetics follow a separate registration process. Filing is not the same as registration, and neither removes the company’s responsibility for the product’s quality and safety.
Build the plan around the actual product version. Gather the formula and ingredient identities, supplier specifications, manufacturing information, safety assessment, product standards, testing and proposed label information. The exact documents and testing depend on classification, ingredients, claims and current rules; agree the list with the domestic responsible person rather than copying an old checklist.
The NMPA says cosmetic safety assessment is required before registration or filing. Its 2024 measures describe a route in which certain qualifying general cosmetics can submit basic safety-assessment conclusions while the enterprise keeps the report for reference. Determine whether the product qualifies rather than treating that option as a waiver of the assessment.
Keep the document list current
Filing requirements can change. Before gathering the dossier, agree the current document list with the domestic responsible person and identify which supplier records the business must obtain and retain. The NMPA has described reforms to registration and filing management, including ingredient safety information; a policy description should not be treated as a substitute for the applicable implementing requirements. NMPA: interpretation of cosmetics regulatory reform.
Prepare the label and evidence for claims
The NMPA’s manufacturing and marketing provisions require a Chinese label for the minimum sales unit, consistent with the registered or filed label, subject to the applicable rules. Review the product name, ingredient presentation, warnings and responsible-party details against current requirements. An electronic-label pilot began in selected areas in 2026 for participating enterprises under specified conditions. The NMPA notice says cosmetics using pilot electronic labels may be produced and sold within China. Check whether the pilot applies to the business and product. NMPA: electronic-label pilot.
Claims and their evidence also need review. Decide what each claim actually promises, locate the relevant supporting evidence and check the applicable Chinese requirements. Evidence collected for another market may be useful, but its suitability and the form of the required submission or record need assessment for this product.
Do not assume every imported cosmetic requires an animal test, or that every product qualifies for an exemption. Confirm current testing requirements and any conditions for the actual formulation and applicant.
Keep the filing aligned with the product
Once filed, keep the approved or filed product information, formula, manufacturing records, safety evidence and label versions accessible to the responsible people. The NMPA’s provisions describe annual reporting for filed general cosmetics and restrictions on changes to filed product information. Establish a change-control process before replacing an ingredient or changing a claim.
Agree how complaints, suspected adverse reactions and potential recalls reach the domestic responsible person and manufacturer. A correct launch file is the beginning of the product’s Chinese compliance history.
Sources
- NMPA: provisions for registration and filing of cosmetics and filing provisions.
- NMPA: safety-assessment policy interpretation and 2024 safety-assessment measures.
- NMPA: manufacturing and marketing provisions.
- NMPA: interpretation of cosmetics regulatory reform.
- NMPA: cosmetic electronic-label pilot.
Frequently asked questions
Does every imported cosmetic follow the same route in mainland China?
No. General cosmetics are filed and special cosmetics are registered. The applicable route depends on the actual product and its claims, ingredients and intended users.
Must an overseas filer appoint a domestic responsible person?
The NMPA's provisions require an overseas registrant or filing person to designate an enterprise legal person within China as its domestic responsible person.
Does the domestic responsible person take over all of the brand's responsibilities?
No. The registrant or filing person remains responsible for product quality and safety. The domestic responsible person has its own specified duties and corresponding quality and safety responsibilities under its agreement.
Are animal tests required for every imported cosmetic?
No universal answer applies. Requirements and available exemptions depend on the product, evidence, applicant and current rules, so the actual filing needs a specific assessment.



