According to The Food Safety Law of China, food for special medical purposes shall be registered with SAMR by providing product formula, production techniques, labels, instructions as well as the materials that prove the product safety, nutrition sufficiency and clinic effect of special medical purpose.
From Jan. 1, 2019, all FSMPs manufactured within China or imported to China should be registered with SAMR prior to the sale in Chinese market, and indicate the registration number on label and instruction. The FSMPs manufactured within China or imported to China with production date before Dec. 31, 2108, can still be on market for sale until the expiration date.
If producers or traders of FSMPs violate the Law by engaging in unauthorized or illegal production or trading activities, the illegally gained benefits, FSMPs and the tools, equipment and raw material used for production or trading will be confiscated. The producer or trader is also subject to a fine between RMB 50,000 to 100,000 if the total value of the commodity is less than RMB 10,000, or a fine between 10 and 20 times if the total value of the commodity exceeds RMB 10,000; for severe violation of the law, the business license of food producers and traders will be revoked.