China to Replace Imported Cosmetic Registration with Filing Management from November 10

Takehome:

• According to ChemLinked exclusive information, National Medical Products Administration (subordinate to SAMR) will no longer accept applications for first-imported non-special use cosmetics administrative licenses from November 10, 2018.
• First-imported non-special use cosmetics filing management will replace registration in NMPA and be expanded nationwide from November 10, 2018.

Select a Qualified Domestic Responsible Person

After filing management expands nationwide, enterprises importing non-special use cosmetics to China are required to entrust a domestic responsible person. 

• The 3rd party responsible agent which is a prerequisite of the cosmetic administrative license application to NMPA is only responsible for the authenticity of the application materials. The responsibilities of the domestic responsible person have increased to include importation, operation and safety of the products, including appointing a specialist for quality and safety management, building product safety management, traceability and adverse effect reporting systems and recalling products.
• The domestic responsible person should be a business entity with the ability to sell cosmetics, which means cosmetic category needs to be included in license's business scope.
• One oversea cosmetic manufacturer can appoint more than one responsible person in China, but one product can only have one domestic responsible person.

*** For foreign enterprises that a company in China, it is advisable to invite experienced experts to help establish a professional filing team. For those that don't have a company in China, it's better to seek Chinese partners who can be responsible for product filing, safety and market behavior.

Cosmetic Filing Procedures

According to Guidance of Filing Management for First-imported Non-special Use Cosmetics, formal technical review will be conducted within 3 months after filing. Once problems are found, importers will be required to stop importation and sale, issue a product recall and will be subject to fines.

To avoid requirements to supplement documents after obtaining the digital filing certificate, overseas companies must confirm that the documents provided to the responsible person don't contain the following mistakes:

1.     Nonstandard Chinese characters, the Chinese Pinyin is missing or misspelled;
2.     Text content of product design packaging (including product labels, product instruction books) is missing or uses nonstandard handwriting;
3.     There are some misspellings of Chinese name, INCI name of raw materials or lack of CI number of colorants in the formula;
4.     Other misspelling.

Testing Institutions

The workload of the Chinese testing institutions accredited to produce the cosmetic product technical/safety data necessary to obtain an administrative license will increase significantly. Now the testing institutions are improving efficiency and shortening the inspection period. For example, Zhejiang Institute for Food and Drug Control established a green channel for cosmetics imported and filed in Zhoushan FTZ, shortening the inspection period to 35 days.