Health Food Technology Transfer Registration in China - China - Food & Food Contact Materials

The revised Food Safety Law of the People’s Republic of China mandates strict supervision and management of health foods. To standardize health food management, the State Administration for Market Regulation (SAMR, formerly the China Food and Drug Administration) has issued the Administrative Measures on Health Food Registration and Filing, the Guide for Health Food Registration and Application, and the Detailed Rules for the Review and Approval of Health Food Registration. These documents specify the detailed requirements for health food technology transfer registration.

What is health food technology transfer registration?

Health food technology transfer registration refers to the process in which the holder of a health food approval certificate fully transfers the production and sales rights, along with the production technology, to another legal entity or organization. The transferee shall reapply for product registration under the guidance of the transferor. The review agency, accordingly, simplifies the review procedures, and if the requirements are met, SAMR will issue a new health food registration certificate to the transferee and cancel the one originally held by the transferor.

Materials required

1. Domestic health food technology transfer/imported health food technology transfer to China

Application form for health food technology transfer registration, along with a legal liability commitment statement from the applicant confirming the authenticity of the application materials;
Copies of the transferee’s entity registration certificate;
Copies of the health food registration certificate and its attachments;
Notarized transfer contract;
Application for cancellation of the original registration certificate provided by the transferor;
Product formulation materials;
Manufacturing process materials;
Reports on efficacy components or characteristic components, hygiene, and stability tests for three batches of samples;
Types, names, and standards of packaging materials in direct contact the health food;
Drafts of product labels and instructions;
- If the transferee applies to change the product name, the following should be submitted:
- Searchable materials demonstrating that the generic name in the product name does not duplicate any registered drug names;
- Searchable materials proving that the product name does not duplicate any registered health food names;
- If the generic name of the product includes words other than the raw material or its abbreviation to indicate the product’s characteristics, a naming explanation should also be provided.
Product technical requirements documents;
Explanation of whether the sample production site and conditions have been changed;
Three smallest sales packaging samples; and
Other materials related to product registration review.

2. Technology transfer registration of imported health food overseas

In addition to submitting the required materials for domestic products, the following should also be provided:

Transfer contract notarized by the notary public in the transferee’s country (or region) and confirmed by the Chinese embassy or consulate in that country (or region);
Qualification documents issued by the relevant government authority or legal service institution in the product’s manufacturing country (or region), certifying that the transferee is an authorized overseas manufacturer of listed health foods;
Documentation from the government authority or legal service institution in the product’s manufacturing country (or region) proving that the health food has been on the market for more than one year, or a safety report on the product’s overseas sales and consumption by the population;
If the product is approved for export by the country (or region) of export, a certificate from the relevant authority in the exporting country (or region) permitting the product to be marketed should be provided;
Original texts of technical regulations or standards related to health foods from the country (region) of production or international organizations;
Statement from overseas manufacturing companies ensuring that health foods exported to China comply with Chinese laws, regulations, and national food safety standards;
Self-inspection report ensuring the effective operation of the quality management system;
Actual samples of packaging, labels, and instructions for the product marketed in the manufacturing country (region); and
If the transferee handles registration affairs through a permanent representative office in China, a copy of the Registration Certificate of Foreign Enterprises’ Permanent Representative Offices in China should be submitted. If the transferee entrusts it to a domestic agency, the original notarized power of attorney and a copy of the business license of the commissioned agency should be provided.

What are the considerations to keep in mind?

If the raw materials have been included in the health food raw material directory and comply with relevant technical requirements, an application for health food registration to filing should be made;
Product technical requirements and other materials should be consistent with the original application materials and registration certificate, and comply with the current regulations, technical specifications, national standards, etc;
If the product is undergoing other registration procedures and an applicant intends to apply for technology transfer, the application for technology transfer will not be accepted until the relevant procedures are completed;

For products undergoing technology transfer registration, an applicant may submit change or renewal registration applications at the same time. However, upon acceptance of the change or renewal registration application, the technology transfer registration application will be terminated.

The entity submitting the samples in the test report should be the transferee;
The application materials should be stamped with the seals of both the transferor and the transferee; and
For health foods with the same raw materials and excipients but different tastes or colors, if safety toxicological tests and function evaluation tests were not conducted during the registration stage, they should be supplemented when applying for technology transfer registration.

Related regulations

Food Safety Law of the People’s Republic of China and its Implementing Regulations
Administrative Measures on Health Food Registration and Filing
Guide for Health Food Registration Application
Detailed Rules for the Review and Approval of Health Food Registration
Procedures for Health Food Technology Transfer Registration

Procedures for health food technology transfer

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