As a professional consulting and regulatory affairs service provider, we are committed to providing clients with comprehensive health food registration, filing, and regulatory consulting services. Our team consists of a group of experienced industry experts and regulatory consultants who possess deep professional knowledge and rich practical experience, enabling us to provide efficient, professional, and reliable services to our clients.

Our Services

Service Content

Our Capabilities

Professional Knowledge:Our team consists of experienced regulatory experts and industry consultants who have a deep understanding of health food registration processes and regulatory requirements.

Efficient Processes:We have optimized the registration process to quickly respond to and handle various registration matters, shortening your product's time to market.

Successful Cases:We have numerous successful cases helping clients smoothly pass through the registration process and obtain health food approval certificates.

Customer Service:We provide one-on-one customer service to ensure that every question you have can be answered promptly and professionally.

Why Choose Us

One-stop Service:From consulting to registration, we provide one-stop services so you don't have to worry about complicated registration processes.
Professional Team:Our team members possess deep industry backgrounds and professional knowledge, enabling us to provide you with precise consulting services.
Cost-effectiveness:Through our professional services, you can avoid time and cost losses caused by insufficient material preparation or unfamiliarity with processes.
Continuous Support:We not only help you complete registration but also provide subsequent supervision and management services to ensure that your products remain compliant.
By choosing us, you will gain a trustworthy partner who helps your health food business enter the market smoothly and efficiently. We look forward to working with you to create a healthy future together.

Registration Scope

'According to the 'Regulations on Health Food Registration and Filing Management', the following health foods need to be registered:

• 'Domestic health foods using raw materials outside the health food raw material directory: The raw materials used for producing health foods must be included in the list publicly announced by the state. If the raw materials used in producing health foods are not included in the national health food raw material directory, then these raw materials need to be registered in advance before they can be used in health food production after approval.'
• 'Health foods imported for the first time: The first import here refers to health foods applying for sale within China that are not from the same country, same enterprise, or same formula (which can be directly filed for listing) that do not belong to supplementary vitamins, minerals, or other nutrients.'

'Registration Applicant Conditions'

• 'Domestic health food registration applicants: Should be legal persons or other organizations registered within China.'
• 'Import health food registration applicants: Should be foreign manufacturers of listed health foods. Those applying for import health food registration should be handled by their resident representative offices in China or by entrusted agencies within China.'

'Declaration Materials'

'Generally requires the following declaration materials'
'1. Health Food Registration Application Form: And a legal responsibility commitment letter regarding the authenticity of application materials from the applicant.'
'2. Copy of applicant's entity registration proof documents: Such as business licenses, etc., to prove the legal identity of the applicant.'
'3. Product Research and Development Report: Including researchers, research time, development process, verification data above pilot scale, reports on safety, health functions, quality controllability of raw materials outside directory based on scientific evidence related to research results.'
4. Product formula materials: Clearly specify the names and quantities of raw and auxiliary materials, production processes, quality standards, etc. If necessary, provide the basis for raw material use, descriptions of usage locations, certificates of inspection compliance, variety identification reports, etc.
5. Product production process materials: Include a flowchart and description of the production process, key process control points and explanations.
6. Safety and health function evaluation materials: Such as safety and health function test evaluation materials, population consumption evaluation materials, efficacy components or signature components, hygiene, stability test reports, and detection reports related to stimulants and banned substances may also need to be provided.
7. Types, names, and relevant standards of packaging materials that come into direct contact with health food.
8. Product label and instruction draft: The common name in the product name must not be the same as the registered drug name and must comply with relevant regulations regarding labels and instructions.
9. Product name search materials: Provide search materials showing that the common name in the product name does not conflict with the registered drug name and that the product name does not conflict with the approved registered health food name.
10. Minimum sales packaging samples: Generally requires 3 minimum sales packaging samples.
11. Other relevant materials: Other materials related to product registration review, such as patent non-infringement guarantees, trademark registration documents, etc.

Registration process

1. Preparation before application: Enterprises need to understand relevant regulations such as the Food Safety Law and the Administrative Measures for Registration and Filing of Health Foods to ensure that the registration process complies with legal requirements and prepare the detailed registration application materials as required.
2. Registration submission: Submit the completed application form and related materials to the National Market Supervision Administration (or its authorized local agency) Food Review Center.
3. Acceptance and review

• The accepting agency will review the submitted application materials to ensure their authenticity and compliance. If issues are found, they will request supplementary materials or conduct investigations.
• The accepting agency should submit the application materials to the review agency within 3 working days after acceptance. The review agency should organize review experts to examine the application materials and organize on-site inspections by verification agencies as needed, conducting re-inspection tests within 60 working days and submitting a comprehensive review conclusion and recommendations to the National Market Supervision Administration.

4. Approval and registration

• The National Market Supervision Administration should review the legality, standardization, and completeness of the review procedures and conclusions within 20 working days from receiving the review conclusions and recommendations, making a decision on whether to approve or deny registration.
• After making a decision to approve or deny registration, the accepting agency should issue a health food registration certificate or a decision of non-registration to the applicant within 10 working days from the date of decision.
• The applicant can collect the health food registration certificate from relevant departments upon notification with the health food registration certificate.

5. Subsequent supervision and management: After approval, the manufacturing enterprise needs to file production with provincial authorities. Provincial authorities will conduct regular supervision and spot checks on approved health foods. The authorities will also conduct regular monitoring sampling inspections of health foods on the market to ensure product quality and safety. If non-compliant products are found, corresponding measures will be taken, such as removal from shelves or recalls.

Registration cycle

Generally speaking, the registration declaration cycle for health foods is relatively long; domestic health foods usually take about 10 months, while imported health foods generally take about 12 months. However, if documentation is insufficient or if additional tests or further information are required during the review process, the declaration cycle may be extended accordingly, potentially reaching up to 2 to 3 years.

Relevant institutions

The declaration of health foods mainly involves several types of institutions

Testing institutions: Responsible for technical testing of products and issuing test reports, such as disease control centers (or health prevention stations) in various provinces and municipalities directly under central government, China CDC Nutrition and Food Safety Institute, etc.

Application acceptance office: Responsible for preliminary review of enterprise application materials, arranging products for review meetings, notifying enterprises of review opinions, reporting products intended for approval to the National Food and Drug Administration (FDA), issuing certificates, etc., such as health food approval acceptance agencies in provincial or municipal drug administration offices.

Expert review committee: Responsible for technical reviews of declared products composed of experts from various fields.

Food management departments: Conduct further reviews on products that have passed technical reviews by expert committees; ultimately have approval authority is held by the National FDA which assigns approved products a health food approval number.