Imported Cosmetics Licensing

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 Accordance

Regulations on the Supervision and Administration of Cosmetics,Administration for cosmetics registration and Record-filing ,Standards for cosmetics registration and Record-filing materials,,Classification Rules and Catalogues of Cosmetics,Evaluation Standards for Cosmetic Efficacy Claims ,Technical Guidelines for Cosmetic Safety Assessment2021 edition).

 

Regulatory Target

All cosmetics that are sold in the Chinese market from overseas. Among them,ordinary cosmetics are required for the filing credential, and special-use cosmetics are required for registration certificate. Products with different formulas, brands, and names are required for filing credential or registration certificate respectively.

 

Among them, special-use cosmetics refer to: cosmetics used for hair dyeing, hair perm, blemish-removal, whitening, sunscreen, anti-hair loss and cosmetics that claim new effects.

 

Cosmetics other than special cosmetics are ordinary cosmetics. Namely: claim to remove acne, nourishing, repairing, cleaning, makeup removal, moisturizing, beauty modification, fragrance, deodorant, anti-wrinkle, firming, soothing, oil-control, exfoliating,refreshing,hair care, anti-hair breakage,anti-dandruff, hair-color care, hair removal, and auxiliary shaving cosmetics. 

 

Record-filing Procedures for Imported Ordinary Cosmetics

Authorization and notarization at home and abroad(this can be omitted in the case of a domestic company entrust an overseas company with production)→initial record-filing→account application→confirm formula,labels→ sample testing→collate other information→submit documents to the NMPA platform→upload a summary of the basis of the product efficacy claim on a website designated by the NMPA→complete the filing project→report the import status to the NMPA that is responsible for filing each year, as well as the compliance with laws and regulations, mandatory national standards, and technical specifications.

 

Registration Procedures for Imported Special-use Cosmetics

Authorization and notarization at home and abroad(this can be omitted in the case of a domestic company entrust an overseas company with production)→initial record-filing→account application→confirm formula,labels→ sample testing→collate other information→submit documents to the NMPA →formal examination(to determine admissibility)→administrative examination and approval(whether approved)→issue a registration certificate

 

Dossiers Required for Account Application

(1) Information sheet of the registrant  and resume of the head of quality and safety;
(2) Overview of the quality management system of the registrant ;
(3) Overview of the adverse reaction monitoring and evaluation system for registrants ;
(4) The overseas registrant  shall submit the information form of the liable person in China;
(5) The original power of attorney of the liable person in China and the original notarial certificate;
(6) If the registranthas produced by itself or commissioned an overseas production enterprise to produce,it shall submit the information form of the production enterprise and the information of the head of quality and safety, and fill in the existing production enterprise and its information at one time.Where the production enterprise is overseas, the original documents certifying the overseas production standards shall be submitted.

 

Dossiers Required for Record-filing

1. Cosmetics Registration and Filing Information Form and relevant materials (including sales certification that the product has been listed overseas).

2. Product name information.

3. Product formula((including name and CAS number of raw material ,percentage, purpose of use, safety information);

4. Carried standard for the product.

5. Product label samples and sales packaging of products from overseas production countries (regions);

6. Product test reports(including microbiological,physical and chemical tests, toxicology tests, human safety tests and human efficacy test reports, etc.); 

7. Product safety assessment .

 

Others:

(1) Upload the summary of the basis for the product efficacy claim on the website designated by the NMPA(starting from January 1, 2022) during registration and filing;

(2)For ordinary cosmetics, report the import status to the NMPA that is responsible for filing each year, as well as the compliance with laws and regulations, mandatory national standards, and technical specifications.

(3)The valid term of the registration certificate for special cosmetics is 5 years, and the holder shall apply for the renewal between 90 and 30 working days before the expiration of the registration certificate.It will automatically become invalid after the expiration date, then must reapply. 

 

Period(including the testing duration)

For imported ordinary cosmetics, it will be 2.5 to 4 months.

For imported special-use cosmetics, it will be 6-20 months depending on the specific type of product efficacy.

 

Others

1. If the conditions for alteration are met, alteration or correction for the registration certificate may be applied for.

2. The registration certificate for imported special-use cosmetics is valid for 5 years, and the holder shall apply for extension 90 working days to 30 working days before the expiry of the registration certificate.Expiration is automatically invalidated and shall be reapplied.

3. For imported ordinary cosmetics, the qualification requirements for responsible party in China:incorporated enterprise, business scope including cosmetics sales, import and export rights.

 

Our Professional Services & Advantages

As one of the senior service organizations of filing and registration for cosmetics in the industry, with profound accumulation in the field of product compliance consulting and experienced technical team, the following services are available:

 

1. To guide domestic and foreign enterprises to proceed the authorization and notarization before filing/registration.  

2. Fully acting for record-filing/registration and testing.

3. Preliminary review services for filing/registration materials and technical guidance services during the application process.

4. Compilation of some documents during the record-filing/registration process.

5. Review of promotion copywriting of product labels.

6. Provide compliance guidance service according to the technical review opinions of NMPA after filing.

 

Why choose ZOOP

1. Trustworthy with more than 10 years of experience in regulatory consulting services and a senior team.

2. Innovative full-process management to ensure high efficiency.

3. Convenient communication,our offices are located in Beijing,Guangzhou,Shenzhen and Shanghai.

4. Quality service,reasonable quotation,more cost-effective and high satisfaction.

5. Domestic/imported/special-use cosmetics/imported disinfector/medical devices,one-stop service with high efficiency to save your worry.

6. More convenient and efficient with ability to communicate thoroughly and effectively in English.