China Health Food Registration


Overview


Health foods refer to food products which claim to aid specific health functions or to supplement the body’s health in the form of vitamins and/or minerals.

Requirements


No matter whether a health food uses ingredients found in the approved health food ingredients catalogue or it is being imported for the first time to China, it is required to register your health food with SAMR; First time import of health foods classified as nutritional supplement, such as vitamin or mineral supplements, must file with SAMR; Other health foods, before launching into the Chinese market, must file with the local food safety supervision departments.

Administrative Department


State Administration of Market Regulation (SAMR)

Relevant Regulations


• Administrative Measures of Health Food Registration and Fling

• Guidance for Health Food Registration (2016 Version)

• Detailed Guidance for Health Food Registration Approval (2016 Version)

• List of Auxiliary Materials for Health Food Filing and Terms of Use (Trial)

• List of Approved Health Food Raw Materials Directory (1st batch)

• Guideline for Health Food Filing Application (Trial)

Our Services


Regulatory Consultation

Communication via email, phone or face to face communication

Main content:

• Understanding of health food regulations

•  Registration and Filing procedure of health food

•  Registration strategies for health food product

• Customized consultation and training

Filing for Domestic Health Food

Filing of nutrient supplements to gain China market access

Main content:

• Feasibility assessment of health food Filing

•  Preparation of Filing materials

•  Filing materials review by experts

•  Filing materials submission and filing number approval

Filing for Imported Nutritional Supplement

Achieve China market approval for imported nutritional supplements

Main content:

• Feasibility assessment of health food filing

•  Preparation of filing materials

•  Filing materials review by experts

• Filing materials submission and filing number approval

Health Food Registration (imported/ domestic)

Gain China market approval

Main content:

•  Pre-evaluation of health food registration: feasibility, timeline and cost

•  Dossier preparation for health food registration

•  Test monitoring for health food registration

•  Communication with assessment experts and authorities