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SAMR Food for Special Medical Purpose (FSMP) Registration

China,Food,FSMP,Registration,Domestic,Import,SAMR

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 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 but put on the Chinese market.

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 FSMPManufacturers of FSMP in China
Imported FSMPManufacturers of FSMP abroad

Manufacturers in China can submit a FSMP registration or appoint a local agent to do so. 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 fulfils 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 proposal, sending sample 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