Cosmetics sold in China have to be approved by NMPA.
Imported SUC, domestic SUC and new cosmetic ingredients require a pre-market registration while imported non-SUC and domestic non-SUC are subject to pre-market filing.
Imported non-SUC need to have a Chinese Responsible Person (RP), who must be the importer and needs to have a cosmetic business licence. They are responsible for the filing as well as the quality and safety of the product.
For non-SUC a product dossier needs to be prepared, which includes also the product specifications obtained during the product testing at one of the NMPA approved laboratories.
This dossier is submitted to NMPA or to a provincial Medical Products Administration, depending on where the RP is based.
The dossier undergoes only an administrative review at this time, where the completeness of the documentation is checked, as well as compliance with the format requirements.
NMPA will then grant a filing certificate, which doesn’t have an expiry date, and non-SUC products can be imported.
Technical review of the filing documents is carried out within 3 months after obtaining the filing certificate, but the products can be already on the market during that time.
Imported SUC require a Chinese Responsible Agent (RA) who can be any legal entity registered in China, and who is only responsible for product registration.
The product dossier and testing requirements are more stringent for SUC than for non-SUC products, but the biggest difference comparing to non-SUC products is, that SUC can be imported only after the technical review is finished and NMPA issues an administrative licence, which is valid for four years.
Despite an increasing number of approved alternative methods to animal testing, cosmetics in China still require testing at the NMPA approved laboratories, which perform test on animals.
Only domestic non-SUC and cosmetics sold through Cross-border E-commerce (CBEC) are able to avoid animal testing.
