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

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.

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 asCIRSChina 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 vitamin and mineral supplements (VMS)
Filing	Domestic health foods using active ingredients that are listed in the Health Food Raw Material Directory. Imported vitamin and mineral supplements (VMS).

Our Services

CIRSChina 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