CHN/1217
WTO/TBT
CN China
  • 11 - Medizintechnik
2017-11-24
2017-09-26

Medical devices

Related Policies about Encouraging the Innovation of Drugs and Medical Devices and Implementing the Whole Life Cycle Management of Drugs and Medical Devices (Draft) (5 page(s), in Chinese)

These policies aim to encourage the innovation of drugs and medical devices and implement the whole life cycle management of drugs and medical devices. The main content is as follows, confirming the legal responsibility of MAH (Marketing Authorization Holder); improving the reporting system for adverse reactions/event of drugs and medical devices; carrying out the re-evaluation of injections in the market; improving the medical device re-evaluation system; investigating and dealing with data fraud of clinical trial strictly; standardizing academic promotion behaviour; strengthening the review capacity; reforming the inspection system of drug sample for clinical trial; implementing inspection responsibility for the whole process from research and development to application; building the professional inspectors' team; and strengthening international cooperation etc.