SAMR Health Food (Dietary Supplement) Registration/Filing in China

Updated on October 17, 2023

Under the revised Administrative Measure on Health Food Registration and Filing (CFDA Order No. 22) issued in 2020, manufacturers or sellers who plan to place health foods on the Chinese market shall apply for and obtain a health food registration certificate or filing certificate. For domestic health foods produced in China, the registration shall be conducted with the State Administration for Market Regulation (SAMR), whereas, the filing shall be carried out with the Provincial Administration for Market Regulation. For imported health foods produced abroad, both the registration and filing shall be applied for with SAMR.

Please click to know more details about China health food registration and filing.

Who Shall Register/File?

• Manufacturers of health food in China

• Domestic companies selling health food in China

• Foreign manufacturers of health food

• Foreign companies selling health food to China

Who Can Be The Applicant (The Certificate Owner) Of Registration/Filing?

Domestic Health Food	Registration	Manufacturers or other companies in China
	Filing	Manufacturers of health food in China
Imported Health Food	Registration	Foreign manufacturers or other companies abroad
	Filing

What Health Food (Dietary Supplement) Need To Be Registered/Filed

Manufacturer or companies in China can submit a health food registration/filing or appoint a local agent to do so. Foreign manufacturers or companies must appoint a local Chinese agent such as CIRS China to submit the health food registration/filing. The local agent should be knowledgeable and qualified to carry out the registration/filing.

There are two types of Chinese market access for health food: registration and filing:

Registration	Domestic health foods using active ingredients that are out of the scope of the Health Food Raw Material Directory. Imported health food excluding nutrition supplements (supplementing vitamins, minerals and other nutrients).
Filing	Domestic health foods using active ingredients that are listed in the Health Food Raw Material Directory. Imported nutrition supplements (supplementing vitamins, minerals and other nutrients).

News Updates

In accordance with the announcement of the State Administration for Market Regulation (SAMR) regarding the release of Directory of Health Functions Available to Be Claimed by Health Food - Non-nutrition Supplements (2023 Version) and the supporting documents, registrants need tochange their health food registration certificates to revise the wording of their health claims, so as to align the latest wording and evaluation requirements when the health functions are listed in the Directory yet the wording of the health claims is outdated (e.g., regulating immunity or improving sleep).

Our Services

CIRS China fulfils all the qualifications and requirements of being a local Chinese agent (registered capital, expertise, etc). We provide all the necessary services in one package to complete registration/filing at the most competitive price in the market.

Our services include:

Formula Compliance Review (Registration/Filing Feasibility Analysis)	Evaluation of whether the ingredients and excipients are compliant with Chinese health food regulations Preparation of a health food registration/filing proposal
Health Food Registration	Data evaluation, data gap analysis, and literature search for the formula Writing testing proposal, sending sample to certified labs Translation and notarization of certifying documents Dossier preparation and submission Tracking the registration status and communication with SAMR
Health Food Filing	Data gap analysis Writing testing proposal, sending sample to certified labs Translation and notarization of certifying documents Dossier preparation and submission Tracking the filing status and communication with SAMR
Label Review	Review the Chinese label and provide modification suggestions

Further Information

Registration Status of Health Food in China in the first half of 2023

Filing Status of Chinese Health Foods (Dietary Supplements) in the First Half of 2023