The Regulations on Supervision and Administration of Medical Devices (Revised Draft) was adopted

In 21st December, the Premier Li Keqiang presides over an executive meeting of The State Council, approved the Regulation on Supervision and Administration of Medical Devices (revised draft). The aim of this revised draft is to strengthen the responsibility of enterprises and research institutions for the safety and effectiveness of medical devices, clear define the medical device  recording and registration approval procedures, beefing up regulatory tools, additional regulations and supervision measures on medical device unique identification traceability(UDI) and extension inspection. It also indicates the significantly increase the amount of fines for serious violations involving medical device quality and safety problems. Severe punishment shall be meted out to companies and persons responsible for serious violations of the law, such as revocation of their licenses, prohibition of entry into trades and markets, and criminal responsibility shall be investigated in accordance with the law if any crime is involved.

Major changes and contents

  • A self-test report is permitted
  • The registration of imported innovative medical devices without overseas listing is allowed
  • To determine the supervision and guidance of the provincial bureau registration administration legal status
  • Strengthened government information disclosure
  • Conditional approval requirements
  • Requirements and guidance for major public health emergencies
  • Scientific and reasonable setting of clinical evaluation requirements
  • Implied license of clinical trial approval
  • Ethical requirements of clinical trials
  • Extended clinical trials requirements
  • Regulations on medical institutions self-made in vitro diagnostic reagents


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