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NMPA Finalizes Tumor Mutation Reagents Guideline for CDx


NMPA (CFDA) published the Registration Technical Review General Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing) on December 5th, 2019. The draft guideline was issued on August 14, 2018.

The document harmonizes with international standards such as those listed on FDA guidance of Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing NGS)– Based In Vitro Diagnostics (IVDs)Intended to Aid in the Diagnosis of Suspected Germline Diseases and Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics.

While NGS has advantages on both sequencing scale and detection of unknown genetic mutations, some aspects are still challenging. This important document not only guides the manufacturers with registration, but also helps with R&D process.

Key Areas in the Tumor Reagent Guideline

  • collection and processing of clinical samples
  • testing items
  • NGS sequencing process
  • data analysis
  • results report
  • verification and validation of technical quality

Takeaways for Manufacturer

  1. Before designing a certain gene test, determine intended use, number of genes to be tested, mutation sites and mutation types, sample type, applicable population and types of information to be assessed;
  2. Prospective research should be conducted to determine the study parameters and relevant standards;
  3. SOP for the whole testing process described and kept, including the sample collection/processing process, library construction, sequencing, data analysis, results report etc.
  4. After market approval, post-market data can be applied to modify the clinical application.

For the English version of Registration Technical Review General Guideline for Performance Evaluation of the Reagents Used for Tumor Related Genetic Mutation Test (high-throughput sequencing) , please email

NMPA has approved four NGS CDx products for clinical oncology in the last two years. Among them, the multiple biomarker-based NGS CDx was approved on November 20, 2018.

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About ChinaMed Device, LLC 

ChinaMed Device, LLC ( provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal representative with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

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