Food for Special Medical Purposes

The NMPA follows national standards (GB 29922-2013) and classifies Food for Special Medical Purposes (FSMP) into four categories:

  • Nutritionally Complete Foods
  • Nutritionally Complete Foods with a Specific Formulation
  • Nutritionally Incomplete Foods
  • FSMP for infants

To sell FSMP products in China, manufacturers may not mention any information on disease prevention or treatment on FSMP labels. In addition, they must instruct customers to use the products under medical or nutritional supervision.

Compulsory registration of FSMP suspended until 2019
On 22.11.2017, the NMPA and the AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine) published a Notice (No. 139-2017) granting a transitional period of one year. From 01.01.2019, FSMP will require NMPA registration for its import and sale in the Chinese market. In 2017, only three and within the first four months of 2018, only two FSMP were registered by foreign manufacturers in China.

  • GB 29922-2013 National Food Safety Standard General Rules for Foods for Special Medical Purposes
  • GB 25596-2010 General Rules of Infant Formula Foods for Special Medical Use

  • NMPA Nr. 24-2016 Administrative Measures for Registration of Foods for Special Medical Purposes
  • NMPA Nr. 123-2016 Requirements on Labelling and Instruction of Foods for Special Medical Purposes (Trial)
  • Application Documents Items and Requirements for Registration of Foods for Special Medical Purposes (Version 2017)
  • Service Guideline for the Registration Approval of Foods for Special Medical Purposes

The process of China NMPA registration of FSMP is demanding. Our experienced consultants can guide you through the regulatory process in China. The NMPA approval for FSMP is valid for 5 years.

The NMPA Legal Agent for FSMP is responsible for the registration, supervision of the tests and administrative aspects during the registration application.

  • Are you a manufacturer and want to sell your FSMP in China?
  • Would you like to know how much time and costs you have to expect for the China NMPA registration of your FSMP?
  • You are unsure who to choose as your NMPA Legal Agent?
  • Do you have any concerns about revealing the exact composition of your FSMP during registration?
  • Advice on relevant regulations
  • Determine under which food category your product falls
  • Legal representation in China as NMPA Legal Agent for registration and regulatory affairs
  • Correspondence and coordination between you and the Chinese authorities in technical and cultural terms
  • Application for China NMPA approval
  • Provide documents including templates and advice on their correct completion
  • Analysis of ingredients and "claims" for compliance with Chinese regulations
  • Translation and notarization of documents and the Chinese label
  • Support of the tests in China
  • Follow-up of the results until the issuance of the NMPA certificate
  • Comprehensive support for follow-up activities (e.g. changes and renewals of registrations)

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