Request a Demo
As revealed by SAMR announcement issued on Oct. 8, 2018, 2 infant formula for special medical purposes obtained FSMP product registration approval (both products designed for premature/low birth weight infants).
Enterprise | Brand | Country |
Abbott | Similac (喜康宝) | USA |
Milupa | Infatrini (纽荃星) | Germany |
Up to now, 18 food for special medical purposes products (FSMP) have been approved in China (see all in Flist). Imported products accounted for the majority of registered products, representing 83%.
FSMP Registrations by Enterprise
Enterprise | Numbers of FSMP registration approval |
Abbott | 6 |
Mead Johnson | 3 |
SHS | 2 |
Hengrui | 2 |
Synutra | 2 |
Beingmate | 1 |
Milupa Gmbh | 1 |
Nestle | 1 |
Amount | 18 |
The competent authority is now accelerating the dossier assessment and approval process involved in FSMP registration (2/3 of registered products were approved in H2 2018). An additional 30 products are currently undergoing review. It also seems unlikely now that the grace period of FSMP registration will be extended. It is important to reiterate that FSMP products without a registration certificate will be banned from entering China’s markets after Jan. 1st, 2019 (read CL news here).
We provide full-scale global food market entry services (including product registration, ingredient review, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
