Registration of first-imported non-special use cosmetics in China has been replaced by filing management. This should make exporting cosmetics to China easier as there will be less restrictions on the port of entry.
The regulatory update was announced by China’s National Medical Products Administration (NMPA) and it was expanded nationwide on November 10, 2018. Under this new regulation, the paper filing system has been replaced by an electronic filing management system.
The new regulatory scheme demands that foreign manufacturers select a domestic responsible person (RP). The responsible person then files a record via the online filing system on NPMA website prior to import. Only after gaining a filing certification, the product will be allowed for import and distribution in China.
The domestic responsible person must be registered in one of the 11 Free-Trade Zones (Tianjin, Liaoning, Shanghai, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan, and Shanxi). RPs can also be located outside the 11 free-trade zones in China and still file an online dossier submission but in order to complete the filing, they will have to get in direct contact with the NMPA.
Summary of regulatory changes:
- Selection of a domestic responsible person
- No limits on the port of entry for the cosmetic products (the import of foreign cosmetics is not limited with 11 free-trade zones)
- The new online filing system has no limit of validity (the previous paper filing system had a four-year validity)
- Requirements for registration remain the same (including animal testing requirement)