NMPA Import General Cosmetics Filling Process

Inquiry

China is the second largest cosmetic consumer market in the world. In China, the National Medical Products Administration (NMPA) is responsible for the registration and filing administration of special cosmetics, general cosmetics, and new cosmetic raw materials. The NMPA implements registration administration for special cosmetics and filing administration for general cosmetics. For companies that want to put general cosmetics onto the Chinese market, they must file with the NMPA, unless the cosmetics are sold through cross-border e-commerce channels. In this article, we uncover the basic process of importing ordinary cosmetics from the NMPA.

Definition of General Cosmetics

NMPA defines cosmetic products as chemical industrial products for daily use that are applied to the skin, hair, nails, lips, and other surfaces of the human body for the purpose of cleansing, protecting, beautifying, and modifying by rubbing, spraying, or other similar methods.

The NMPA classifies cosmetics into two categories, general cosmetics and special cosmetics, based on the use, composition, and risk of the product.

General cosmetics

General cosmetics refer to those products used for daily skin care without special functional or medical effects.

Ordinary cosmetics include but are not limited to:

Cleansing products
Skin care creams, lotions
Beauty lotions
Sunscreen products (without UV protection)
Makeup products such as lipsticks, eye shadows, etc.
Shampoos and conditioners

Registration and filing of general cosmetics is relatively simple and does not require the provision of clinical trial data, but they still need to comply with NMPA regulations on product safety and labeling.

Special cosmetics

Special cosmetics mainly refer to cosmetic products with special functions. The use and effect of these products involves human health, so safety requirements are relatively high.

Specialty cosmetics include:

Sunscreen products (containing UV protection)
Hair dyeing and perming products
Whitening products
Hair removal products
Anti-wrinkle products
Anti-pigmentation products

For special cosmetics, the NMPA requires more detailed safety assessment reports and related proof of efficacy, including possible clinical trial data.

Information Required for the First Filing Application

NMPA stipulates that applicants should meet the following conditions:

An enterprise or other organization established by law
A quality management system that is compatible with the application for registration and conducting the filing of cosmetics
The ability to monitor and evaluate adverse reactions

The first filing for the import of ordinary cosmetics, the applicant shall submit the following information:

Overseas filer information sheet and resume of the person in charge of quality and safety
Overview of the quality management system of the overseas filer

(1) Formulation source

(2) Material procurement

(3) Manufacturer selection and management system

(4) Product release

(5) Independent of the production company's quality management measures

(6) Quality self-examination and error correction

Overview of the adverse reaction monitoring and evaluation system for overseas filers
Overseas filers shall submit the information sheet of the responsible person in China.
The overseas filer shall submit the original authorization letter of the responsible person in China and the original notary certificate thereof.
If the overseas filer has entrusted production to overseas enterprises, it shall submit the information sheet of the production enterprise and the resume of the person in charge of quality and safety. If the manufacturer is overseas, it should submit the original certification of an overseas production standard (GMP or ISO).

Basic Information Requirements

Cosmetic registration and filing information form
Product formulation and raw material safety information
Raw material safety information including raw material trade name, composition, recommended additives, use restrictions, shape, physical and chemical properties, description of the type of production process, product quality and safety control.
Brief description of the production process and a sketch
Imported products in the country of origin of the original packaging (including product labels, product instructions) and translations by the NMPA recognized by the licensed inspection agency issued the inspection report and related information
Efficacy evaluation test report
Imported products in the production country (region) or country of origin (region) production and sales documents
Product safety assessment information
Overseas filers and OEM factories commissioned the original processing agreement
Other information that may help with the filling, such as the quality specifications of certain raw materials, etc.

Workflow

The whole filing cycle is estimated to be about half a month. The specific workflow is as follows:

Preparation of an authorization letter, notarization and review of system documents
Packaging and formula review
Registrant user rights application
Obtain user rights, send the product for inspection, carry out inspection
Safety assessment report writing
Efficacy testing of product efficacy claims (if any)
Preparation of other documents during testing
Obtaining test reports, compiling all information, and submitting ‍documents

Proregulations provides a full range of services for companies to file and register cosmetic products with the NMPA, ensuring compliance with the latest regulatory requirements. Please feel free to contact us if you need to file your imported general cosmetic products with the NMPA.