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发布日期:2021年02月28日
Overseas Clinical Data

China Med Device provides turnkey solutions for all clinical pathways in medical device/IVD/CDx/combination products.

Key clinical pathways are: Clinical evaluation report (CER), and clinical trial, overseas clinical data acceptance and real-world data/study.

The purpose of submitting overseas clinical data is to convince the NMPA reviewer that the clinical data obtained from previous overseas clinical trial is also valid under China’s regulatory environment, and the previous clinical results and conclusions are also applicable for Chinese patients. There are 3 NMPA required fundamental principles for overseas clinical data:

  • Ethical principle
  • Legal principle
  • Scientific principle

Other than the fundamental principle, NMPA reviewer will consider three major differences when deciding if the overseas clinical data can be accepted or not.  The 3 difference are:

  • Regulatory technical review differences
  • Ethnical differences
  • Clinical environment differences

For complete Oversea Clinical Data regulation interpretation, please check our previous blog: CFDA Must Read: Acceptance of Overseas Clinical Data.

 

China Med Device’s overseas clinical data submission service consists of three phases including:

Phase I – Feasibility Evaluation

In the Phase I evaluation, CMD will review all existing materials and evaluate if its overseas clinical data meets the three fundamental principles and rules set by NMPA.

 

Phase II – Differences Analysis and Justification

In the Phase 2 stage, CMD will help you to analyze the three major differences and justify that the overseas clinical trial data and conclusion is also applicable for Chinese patients.

 

Phase III – Submission and Follow-up

CMD will submit the overseas clinical data and analysis report to NMPA with the registration dossier. CMD will assist you to address questions raised by NMPA reviewer during the supplementary phase.

 

Find more information about current China NMPA Clinical Pathways for Medical Device Registration in this whitepaper: Current China NMPA Clinical Pathways for Medical Device Registration.