According to the opinions of the State Food and Drug Administration, the following explanation is given for Note 2 of the “List of Cross-border E-commerce Retail Import Commodities (Second Batch)” “Medical devices and special foods (including health foods, special medical purpose formula foods, etc.) that need to be registered or filed according to law shall be implemented in accordance with the relevant laws and regulations of the country”:
I. Regarding medical device-related products
The “Chinese product names” corresponding to the tariff number column cannot correspond one-to-one to medical device products. Among them, medical devices should be registered or filed in accordance with medical device regulations. Medical device products that have been approved for registration or filing in accordance with the law can only be imported in accordance with relevant laws and regulations.
The State Food and Drug Administration reminds consumers that there are great safety risks in purchasing unregistered products. The list of products that have been registered or filed for imported medical devices can be queried in the “Imported Medical Devices” and “First Class Medical Device Filing Information” databases in the “Data Query” column on the website of the State Food and Drug Administration.
II. Health food related products
The newly revised Food Safety Law stipulates that health foods imported for the first time shall be registered with the State Food and Drug Administration. Among them, those that supplement vitamins, minerals and other nutrients shall be reported to the State Food and Drug Administration for record. In order to standardize the registration and record management of health foods, the State Food and Drug Administration has promulgated the “Health Food Registration and Record Management Measures”, which will be implemented on July 1, 2016. At that time, health foods imported for the first time must apply for registration with the State Food and Drug Administration, and health foods that supplement vitamins, minerals and other nutrients for the first time must be recorded with the State Food and Drug Administration. Health food retail through cross-border e-commerce shall also comply with the above provisions.
The State Food and Drug Administration reminds consumers that there are food safety risks when purchasing health foods that have not been registered or recorded. The list of imported health foods that have been approved for registration or record can be found in the “Imported Health Food” database in the “Data Query” column on the website of the State Food and Drug Administration.
III. About Special Medical Purpose Formula Food Related Products
The newly revised Food Safety Law stipulates that the formula of infant formula milk powder and special medical purpose formula food shall be registered by the State Food and Drug Administration. On March 7, 2016, the State Food and Drug Administration promulgated the “Registration and Administration Measures for Special Medical Purpose Formula Food”, which stipulates that special medical purpose formula foods produced, sold and imported in the country shall be registered. The measures will be implemented on July 1, 2016. From January 1, 2018, special medical purpose formula foods sold in my country, including those imported through cross-border e-commerce retail, must obtain product formula registration certificates in accordance with the law.
By then, the list of special medical purpose formula foods that have obtained product formula registration certificates will be announced on the website of the State Food and Drug Administration.
Like cosmetics, health foods must have the approval of the State Food and Drug Administration before they can be imported through cross-border e-commerce. Among them, we need to divide health foods into two categories: one is health foods imported for the first time (except health foods that supplement vitamins, minerals and other nutrients); the other is health foods that supplement vitamins, minerals and other nutrients imported for the first time. For the former, registration is required, which usually takes more than one year and is expensive; for the latter, only filing is required, which can usually be completed on the spot and does not cost much.
For medical device-related products and special medical purpose formula food-related products, the regulatory approach is basically the same as general trade imports. That is, you need to obtain the corresponding approval documents before you can import through cross-border e-commerce.