China Cosmetics Filing and Registration

As required by regulations, all cosmetics that are sold in the Chinese market from overseas (including Hong Kong, Macao and Taiwan) must be filed and approved by the National Medical Products Administration, to obtain the filing credential for imported ordinary cosmetics and special-use cosmetics must be registered and obtain the registration certificate  before declaring in customs and then marketing. Otherwise, severe penalties will be imposed.

Legal Basis

Regulations on the Supervision and Administration of Cosmetics,

Administrative Measures for Cosmetics Registration and Filing,
Standards for Cosmetics Registration and Filing Materials,
Rules and Catalogues for Cosmetics Classification,
Standards for the Evaluation of Cosmetic Efficacy Claims,
Technical Guidelines for Cosmetic Safety Assessment (2021 edition).

Regulatory Target

All cosmetics imported and sold in the Chinese market. Among them, ordinary cosmetics require a filing certificate, while special cosmetics require a registration certificate. Products with different formulas, brands, or product names must undergo separate filing or registration.

Special cosmetics refer to products used for hair dyeing, hair perming, spot-removal, whitening, sunscreen, anti-hair loss, as well as cosmetics claiming new efficacy.

Cosmetics other than special cosmetics are ordinary cosmetics. For example: products claiming functions such as anti-acne, nourishing, repairing, cleansing, makeup removal, moisturizing, beautifying/modifying appearance, fragrance, deodorizing, anti-wrinkle, firming, soothing, oil control, exfoliating, refreshing, hair care, anti-hair breakage, anti-dandruff, hair color protection, depilatory, and auxiliary shaving.

Filing Procedures
Domestic and overseas authorization and notarization (may be omitted if a domestic company entrusts an overseas company with production) → Pre-filing preparation → Account application → Confirm formula and labels → Product testing → Compile other required documents → Submit documents to the NMPA filing platform → Upload a summary of the basis for efficacy claims on the NMPA-designated website → Complete the filing → Annually report the import status to the NMPA responsible for filing, as well as compliance with relevant laws, regulations, mandatory national standards, and technical specifications.

Registration Procedures
Domestic and overseas authorization and notarization (may be omitted if a domestic company entrusts an overseas company with production) → Pre-registration preparation → Account application → Confirm formula and labels → Product testing → Compile other required documents → Submit documents to the NMPA → Formal review (to determine acceptance) → Technical review and administrative approval (decision on approval) → Issue of registration certificate.

Dossiers Required for Account Application

1. Information sheet of the registrant and résumé of the person in charge of quality and safety;

2. Overview of the registrant’s quality management system;

3. Overview of the registrant’s adverse reaction monitoring and evaluation system;

4. For overseas registrants, information sheet of the responsible person in China;

5. Original power of attorney of the responsible person in China and original notarized certificate;

6. If the registrant manufactures by itself or entrusts an overseas manufacturer, it shall submit the manufacturer’s information form and information of the person in charge of quality and safety, and disclose existing manufacturers and their information in one submission. Where the manufacturer is overseas, original documents certifying compliance with overseas production standards shall be submitted.

Dossiers Required for Filing

1. Cosmetics Registration and Filing Information Form and relevant materials (including overseas sales certificate of the marketed product);

2. Product name information;

3. Product formula (including raw material names and CAS numbers, percentages, intended use, and safety information);

4. Product implementation standard;

5. Product label samples and sales packaging used in the country/region of origin;

6. Product testing reports (including microbiological, physicochemical, toxicological, human safety, and human efficacy test reports, etc.);

7. Product safety assessment.

Additional Requirements

1. Since January 1, 2022, a summary of the basis for efficacy claims must be uploaded to the NMPA-designated website during registration and filing.

2. For ordinary cosmetics, the filing entity must annually report the import status to the competent NMPA authority, and confirm compliance with laws, regulations, mandatory national standards, and technical specifications.

3. The registration certificate for special cosmetics is valid for 5 years. The holder shall apply for renewal between 90 and 30 working days before expiry. Upon expiry, the certificate automatically becomes invalid and a new application is required.

Processing Period (including testing time)

• Imported ordinary cosmetics: approx. 2.5 to 4 months;

• Imported special cosmetics: approx. 6 to 20 months depending on the product’s claimed efficacy.

Other Notes

1. If alteration conditions are met, the registrant may apply for modification or correction of the registration certificate.

2. The registration certificate for imported special cosmetics is valid for 5 years. The holder shall apply for renewal 90–30 working days before expiration. Upon expiry, the certificate automatically becomes invalid and a new application is required.

3. For imported ordinary cosmetics, the responsible person in China must be a legally incorporated enterprise, with business scope covering cosmetics sales and import/export rights.