Registration of Food for Special Medical Purpose

Food for Special Medical Purpose (FSMP)refers to a category of foods specially processed or formulated to meet the specific nutritional needs of consumers with a limited or impaired capacity to intake, digest, absorb or metabolize conventional foods. Also, for consumers with a particular disease and/or condition, including, which includes FSMPs for infants (0-12 months) and FSMPs for peopleabove 1 year old.

Requirements

According to China’s Food Safety Law, FSMP must be registered with SAMR by providing product formula, production techniques, labels, instructions as well as the materials that prove product safety, nutrition suciency and clinical eect of special medical purpose.

From Jan. 1, 20 1, all FSMPs manufactured within China or imported to China must be registered with SAMR prior to sale in Chinese market.

Administrative department

State Administration for Market Regulation (SAMR)

Relevant regulations

  • Administrative Measures for Registration of Foods for Special Medical Purpose
  • Label and Instruction of Foods for Special Medical Purpose (Trial)
  • Stability Study Requirements for Foods for Special Medical Purpose (Trial)
  • Requirements for Application Materials for Registration of Foods for Special Medical Purpose (Trial)
  • Checkpoints and Judgment Principles for Manufacturer Field Inspection for the Registration of Foods for Special Medical Purpose (Trial)
  • Clinical Trial Quality Management Standard for Foods for Special Medical Purpose (Trial)

REACH24H Service

Regulatory Consultation

Communication via internet, telephone and face-to-face

Main content:

1) Management regulations of FSMP

2) Registration procedure of FSMP

3) Registration strategies of FSMP

4) Customized consultation and training

Compliance Review

Check if the FSMP complies with Chinese regulations

Main content:

1)Product formula review

2)Label review

3)Ingredients and additives review

4)Consultation on product R&D

Pre-review of Product Registration

Evaluate the capacity of R&D,testing and production of the manufacturer

Main content:

1) Qualification review of the manufacturer

2) R&D materials review

3) On-site factory audit

4) Communication with experts and competent authorities

FSMP Registration

Get administrative approval of FSMPs

Main content:

1) Preliminary evaluation: feasibility, timeline and cost

2) Dossier preparation and submission

3) Test monitoring for registration

4) Communication with experts and evaluaiton department

contact us


  • Tel: 0571-87007036
  • Fax: 0571-87007566
  • Add: 14th Floor, Building No. 3, Haichuang Technology Center, 1288 West Wen Yi Road, Hangzhou, China 311121
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