Timeline and Budget for Health Food Access to the Chinese Market - Regulatory News - Food & Food Contact Materials

1. Compliance Procedures of Health Food Access to the Chinese Market

Among above 3 steps, “health food registration or filing” is the most important step. It is a prerequisite for imported health food to enter the Chinese market, and takes a certain amount of time and cost to get the final registration or filing approval. Overseas companies who are interested in China market need to have an overall understanding of health food registration and filing requirements in China before starting relevant projects.

2. Imported Health Food Registration or Filing

In accordance with Food Safety Law of China (2015 version), companies who plan to place health food in Chinese market shall apply and obtain the health food registration certificate or filing certificate.

2.1 Imported Health Food Registration

Registration background

Application scope	All imported health food (excluding nutrition supplement that only provides vitamin and/or mineral)
Applicant qualification	Oversea manufacturers (refer to the legal person and other organization)
Authority	SAMR (former CFDA)

Estimated registration timeline

Registration procedures	Estimated duration
Feasibility analysis	7 workdays
Original documents and test sample preparation	Depends on the applicant
Registration tests	8-16 months
Dossier preparation and submission	About 3 months
Registration application acceptance	5 workdays
Transfer materials to Health Food Review Center	3 workdays
Technical evaluation	60 workdays
Re-test and on-site verification if necessary	Case by case for imported products
Submit supplement dossier if necessary	Within 3 months
Report to SAMR	5 workdays
SAMR make approval decision, issue registration certificate	33 workdays
Total	2-3 years

Estimated registration budget

There are two parts of budget: test fee and consulting fee.

Items	Estimated budget	Budget arrangement
Test fee, which include: Self-tests; Functional components or characteristic ingredients tests, hygiene test and stability test; Methodological validation on functional components or characteristic ingredients test methods; Toxicology test; Animals function and (or) human feeding trials.	See the Guideline	See the Guideline
Consulting fee	See the Guideline	See the Guideline

2.2 Imported Health Food Filing

Filing background

Application scope	The imported nutrition supplements of which the vitamins and (or) minerals meet the requirements in the Health Food Raw Materials Directory.
Applicant qualification	Oversea manufacturers (refer to the legal person and other organization)
Authority	SAMR (former CFDA)

Estimated filing timeline

Filing procedures	Estimated duration
Filing feasibility analysis	3 workdays
Original documents and test sample preparation	Depends on the applicant
Filing tests	About 4 months
Dossier preparation and submission	About 1 months
Submit supplement dossiers if necessary	Case by case (usually within 1 month)
Get filing approval	Case by case (usually within 1 week)
Total	About 6 months

Estimated filing budget

There are two parts of budget: test fee and consulting fee.

Items	Estimated budget	Budget arrangement
Test fee, which include: 3 batches of functional components or characteristic ingredients tests, hygiene tests, and stability test; 3 batches of tests including all items listed in product technical requirements;	See the Guideline	See the Guideline
Consulting fee	See the Guideline	See the Guideline

Section 4 of which is issued by CIRS provides detailed information according to below structure:

1. Compliance Procedures of Health Food Access to the Chinese Market

2. Imported Health Food Registration or Filing

2.1 Imported Health Food Registration (including registration process, dossier requirement, test requirement, timeline, budget, etc.)
2.2 Imported Health Food Filing (including filing process, dossier requirement, test requirement, timeline, budget, etc.)

The summary of each section in the Guideline is introduced by a series of articles which are available as following. If it is of your interest, please kindly click to get information as following.

Section 1: Information to Know before Health Food Exportation to China

Section 2: How Many Health Food are Registered in China?

Section 3: Chinese Health Food Regulation in Present and Future

Section 4: Timeline and Budget for Health Food Access to Chinese Market

Section 5: How does Chinese Government Supervise the Health Food?

Section 6: Cross-Border E-Commerce (CBEC): New Opportunity for Imported Health Food to Enter the Chinese Market

In addition, if you would like to get the od Exportation to China> to get more complete information, please click here to order it.

Editor:

CIRS Food Technical Team: Established in 2012, CIRS Food Technical Team has more than 80% masters with degrees of Food Safety or Food Engineering and more than 50% members from oversea renowned universities. Since it was founded, based on the rich experience of regulatory compliance and deep understanding of Chinese food regulations and industry, food specialists have made comprehensive and reasonable solutions for many oversea food companies to complete Chinese food regulatory compliance progress.

If you have any other questions, please contact us at service@cirs-group.com.

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