SAMR Food for Special Medical Purpose (FSMP) Registration

Under the Administrative Measures for Registration of Food for Special Medical Purposes (CFDA Order No. 24) released in 2016, companies shall submit Food for Special Medical Purposes (FSMP) registration to the State Administration for Market Regulation (SAMR). The registration not only applies to domestic FSMP produced and marketed in China, but also to imported FSMP produced abroad put on the Chinese market.

News updates

On December 1, 2023, the State Administration for Market Regulation (SAMR) released the revised Administrative Measures for Registration of Food for Special Medical Purposes (hereinafter referred to as the new regulations), which consists of 7 chapters and 64 articles. The Measures were implemented from January 1, 2024. Compared with the previous edition, the revised Measures are mainly changed in ten aspects .

Who Shall Register?

• Manufacturers of FSMP in China.

• Foreign manufacturers selling FSMP to China.

Who Can Be the Applicant (The Certificate Owner) of Registration

Domestic FSMP	Manufacturers of FSMP in China
Imported FSMP	Manufacturers of FSMP abroad

Manufacturers in China can submit an FSMP registration or appoint a local agent. Foreign manufacturers must appoint a local Chinese agent like CIRS China to submit the FSMP registration. The local agent should be knowledgeable and qualified to carry out the registration.

Our Services

CIRS China fulfills all the qualifications and requirements of being a local Chinese agent (registered capital, expertise, etc). We provide all the necessary services in one package to complete registration at the most competitive price in the market.

Our services include:

Formula Compliance Review (Registration Feasibility Analysis)	Evaluation of whether the recipe is compliant with Chinese regulations Preparation of a FSMP registration proposal
Health Food Registration	Data evaluation and data gap analysis Writing testing proposals, sending samples to certified labs Translation and notarization of certifying documents Dossier preparation and submission Tracking the registration status and communication with SAMR
Label Review	Review the Chinese packaging/label and provide modification suggestions

Further Information

【FSMP】Nutritionally Complete Food for Ages 1-10: Formula Research and Design Recommendations (Part 1)

【FSMP】Nutritionally Complete Food for Ages 1-10: Formula Research and Design Recommendations (Part 2)

A Comprehensive Review of the Registration and Approval Status of Foods for Special Medical Purpose (FSMP) in 2023

List of 181 Registered FSMP Products (As of March 31, 2024)