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China Ends 8-Year Freeze on Imported Health Food Registration with New Approvals

After a nearly eight-year freeze, China's registration channel for imported health foods is viable again. This is a significant positive signal for international brands, creating a major new opportunity to enter the Chinese market through the more regulated "blue hat" pathway.

After an eight-year standstill, China has approved the registration of five new imported health food products recently, signaling a significant breakthrough for international brands looking to enter the Chinese market. The approvals break a long-standing impasse in the registration of imported health supplements, injecting a fresh dose of confidence into the industry and unlocking market potential.

Breaking an Eight-Year Gridlock 

China implemented a dual-track system of registration and filing for health foods on July 1, 2016, which initially accelerated market access. In 2017 alone, 17 imported health foods were successfully approved. However, progress stalled, and since 2018, not a single new product had managed to pass the registration process. The recent breakthrough follows improvements to China's regulatory framework and better conditions for conducting on-site inspections.

A major hurdle for imported products has been the on-site inspection requirement by Chinese authorities. This includes a challenging "dynamic inspection," where inspectors must observe the product during its actual manufacturing process. For many overseas factories, this requirement has posed significant scheduling and coordination challenges, leading to a long backlog of applications.

The Five Breakthrough Products 

According to the China Special Food Information Inquiry Platform, five imported products have now successfully obtained registration approval. The details are as follows:

Approval No.

Product Name

Health Function

Key Ingredient

Suitable Population

Applicant

国食健注J20250001

Wright Life Notoginseng And Panax Quinquefolius Capsules

Helps enhance immunity

Notoginseng, Panax Quinquefolius

Immunocompromised individuals

WRIGHT LIFE PHARMACEUTICAL LIMITED

国食健注J20250002

Helmig's Curcumin Tablet

Helps maintain healthy blood lipid levels; Provides auxiliary protection against chemical liver injury

Turmeric extract

People at risk of chemical-induced liver injury / People with elevated blood lipids

PT. HELMIGS PRIMA SEJAHTERA

国食健注J20250003

Wright Life Ganoderma Spore Capsules

Helps enhance immunity

Broken Ganoderma lucidum Spore Powder (Irradiated), Ganoderma lucidum Extract

Immunocompromised individuals

WRIGHT LIFE PHARMACEUTICAL LIMITED

国食健注J20250004

Wright Life Blueberry Lutein Capsules

Alleviates visual fatigue

Blueberry extract, Lutein powder (Lutein, Maltodextrin)

People prone to visual fatigue

WRIGHT LIFE PHARMACEUTICAL LIMITED

国食健注J20250005

Wright Life Agaricus Blazei Ganoderma Capsules

Helps enhance immunity

Agaricus blazei Extract, Ganoderma lucidum Powder (Irradiated), Ganoderma lucidum Extract

Immunocompromised individuals

WRIGHT LIFE PHARMACEUTICAL LIMITED

Notably, four of the five approved products belong to WRIGHT LIFE PHARMACEUTICAL LIMITED. It is reported that Wright Life took a proactive stance by requesting that the review center conduct an on-site inspection of its factory. This initiative in seeking solutions helped pave the way for its products' rapid approval, setting the company apart from many others that have remained in a passive waiting state. 

A Positive Signal for the Global Market 

This major development sends a clear and positive signal to overseas health food companies that the import registration channel is once again viable. The approvals are seen as a powerful boost for the industry, breaking the long-standing registration deadlock and activating market potential. It is recommended that international companies with plans to enter the Chinese market via general trade begin early strategic planning and proactively pursue their applications. For enterprises seeking guidance on this process, ChemLinked Expert Team provides professional assistance to help navigate the complexities of registration and filing. 

Our End-to-End Health Food Registration Service Ensures Smooth Compliance

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  • Health food filing (product research, dossier preparation & submission, test monitoring, communication with SAMR )

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