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NMPA Requirements for IVD Clinical Trial Protocol Design


NMPA published draft version of IVD Clinical Trial Guideline for feedback on November 22, 2018. The draft guideline lists eight requirements for IVD clinical protocol.

  1. General information

Including product information, time and personnel of clinical trials, relevant information of the sponsor, relevant information of the sponsor, etc.

  1. Background information on clinical trials
  2. Study objectives
  3. Study design

Including clinical trial methods, determination of clinical reference standards or selection of comparative reagents, selection of validation methods (if any), selection of clinical trial institutions, subject selection criteria, sample size estimation, sample size distribution, clinical evaluation Indicators, statistical analysis methods, etc.

  1. Study management

Including clinical trial procedures, bias control, clinical pre-test training, clinical trial quality control, data management, sample management, analysis of the likelihood of adverse events, and provisions for adverse events and product defect reporting;

  1. Provisions for the amendments of clinical trial protocol
  2. Ethical issues and descriptions of clinical trials and the text of informed consent (if any)
  3. Other content that needs to be explained


For English version of IVD Clinical Trial Guideline (draft), please email

For English version of Medical Device Clinical Trial Guideline (final), please email us also.

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About ChinaMed Device, LLC 

ChinaMed Device, LLC ( provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.

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