Clinical trial protocol is a vital component in IVD clinical design and, in China, the details of the protocol never fail to be questioned by NMPA (CFDA) reviewers. ChinaMed Device, LLC summarizes the key issues in writing IVD clinical protocols:
In addition, all materials need to be well organized. Some NMPA reviewers, if not all, are very strict about the format and content order. ChinaMed Device, LLC has processed 1,000+ NMPA (CFDA) certificates. We can provide the clinical trial protocol of similar products for your reference. info@ChinaMedDevice.com.
ChinaMed Device recommends manufacturers to refer to the following NMPA requirements to revise IVD protocol.
including product information, time and personnel of clinical trials, relevant information of the sponsor, relevant information of the sponsor, etc.
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.);
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;
NMPA published a draft of IVD Clinical Trial Guidelines for feedback on November 22nd, 2018. For specified requirements for clinical protocol design, please email us at info@ChinaMedDevice.com.
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ChinaMed Device, LLC (www.ChinaMedDevice.com) 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.