Medical Device CRO Services

Clinical Evaluation Reports and Medical Device Clinical Trials:

China Med Device can be your partner for expediting Clinical Evaluation Reports (CER) and Clinical Trials (CTs) in China. China’s new requirements for Clinical Evaluation Reports and Clinical Trials have now been in place for more than two years. Understanding the difference between CERs and CTs and their appropriate use can save manufacturers significant cost and time to get to market. China Med Device has over 10 years of clinical trials and management experience. Our team understands both Western and Chinese regulation practices and can help you manage the whole clinical trial process by offering:

  • Clinical trial protocol design
  • Clinical trial assessment
  • Sample size determination
  • Hospital & ethical committee review & approval
  • Clinical trial auditing
  • Monitoring & ensuring data quality with CRC and CRA, data management, analysis & reporting
  • Handling AE/SAE
  • Statistical analysis

China Med Device Clinical Trial Process Flow Chart

Clinical Trial flow chart

For more information about recent updates for clinical trials/CER, please check our following white papers and blogs:

ARTICLE: ‘China to Speed Up Approvals Of New Drugs and Medical Devices By Accepting Overseas Trial Data’