Health food/ Neutriceutical product registeration consulting service

Health food/ Neutriceutical product registeration consulting service

Health food registration service

According to th “HEALTH FOOD CONTROL ACT” which promulgated by TFDA, the term “Health Food” shall denote food with health care effects, having been labeled or advertised with such effects. The term “Health Care Effects” shall mean an effect that has been scientifically proven to be capable of improving people’s health, and decreasing the harms and risks of diseases. However, it is not a medical treatment aimed at treating or remedying human diseases.

Experimental design:Health care effect assessment, Stability test, Safety assessment, Sanitary specification test, Open package test, Excursion test, Disintegration/Brittleness test, Submission for Health Food Registration.

Assessment of health care effectAssessment of the regulation ability on hyperlipidemia, Assessment of the regulation ability on gastrointestinal functions, Assessment of the regulation ability on immunity, Assessment of the protection ability on damaged liver, Assessment of the regulation ability on obesity, Assessment of the regulation ability on allergy, Assessment of the protection ability on bone health, Assessment of the regulation ability on blood glucose, Assessment of the reduction ability on fatigue during exercise, Assessment of the regulation ability on anti-aging, Assessment of the protection ability on tooth, Assessment of the enhancement ability on iron absorption, Assessment of the regulation ability on blood pressure.

Consulting services: Submission for Health Food Registration, Application for non-traditional food ingredients, Customized scientific research, Consulting of governing food safety and sanitation, Professional experimental design and matching for testing institute.

服務內容

 

中國

  1. 國產 /進口醫療器械 中國註冊服務
  2. 中國 醫療器械動物試驗設計及臨床 豁免評估
  3. NMPA 中國醫療器械產品注册及可用性評估
    產品技術要求撰寫
    產品註冊檢驗追蹤
    產品註冊申報資料編寫
    註冊補充資料技術指導
    專家審評會組織協調
  4. NMPA 中國醫療器械臨床試驗
    臨床試驗方案及總結報告撰寫
    臨床試驗項目管理
    臨床試驗監察
    臨床試驗數據管理
    臨床試驗統計分析
    稽查及培訓
    臨床試驗數據採集分析系統
    臨床評價報告(CERCER)撰寫