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CFDA Reconstruct the Medical Device Clinical Trial Policies in China

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May 11th 2017, CFDA issued a policy ‘Encourage Medicines and Medical Devices Revolution Innovate Clinical Test Management System Regulations (first draft)’. CFDA encourages publics to make suggestions before May 25th 2017 through Email (yhzcszhc@cfda.gov.cn). The deadline is June 10th 2017.
Main Content:
  • Cancel clinical test institutions’ qualification authentication, registered in the management system instead.
1. Authorize third party clinical test institutions qualification instead of government organization only.
2. Third party clinical test institutions should employ senior researchers who already involved in at least three times of clinical tests.
  • Encourage clinical test institutions, clinical research institutions and medical universities involve in the clinical tests.
1. International companies and scientific research institution can conduct medical I period clinical tests in China.
2. Clinical test industry would be more compatible in the future
  • Enhance Ethical Committee regulation
1. Protect trial subjects’ safety, health and rights
  • Increase the efficiency of ethical examination
1. Increase the Ethical Committee group quantity.
  • Upgrade clinical test examination procedure
1. Efficient communication between the applicant and clinical test institutions
2. After 60 days, if clinical test institutions do not deny the application, clinical test would be automatically conducted.
  • Accept oversea clinical test data
1. If Chinese clinical test institutions conduct the on-site oversea inspections and all the results meet the CFDA Standard, the data can be used for registration in China.
2. Except the class III medical devices, all the other international products that already selling in the local market can use their local registration clinical test data for the China CFDA registration.
  • Encourage extensional clinical test
1.Under emergency situation, like life-threatening without efficient medicines and medical devices, preliminary studied medicine or medical devices and also processed by the Ethical Committee can be used on the patients who are aware of the risk and truth of taking these medicines or medical devices .

  

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