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The Number of National Standard Materials Types for IVD Increased from 61 to 93


In order to ensure the implementation of “Registration of IVD Reagents Administrative Decree”, National Institute Food and Drug Control (NIFDC), a national testing center authorized by CFDA, issued the third edition of the “National Standard and Reference reagents Catalog for Registration Testing IVD” (Catalog). In the catalog, CFDA increased the number of national standard material types from 61 to 93.

National standard/reference material is one of the significant criteria in the IVD registration process. For both domestic IVD or import IVD, the CFDA registration applicants need to buy the published national standard/reference material that corresponds to their own applying for registration product from NIFDC. The CFDA registration applicant can have the base to make comparison to verify that the applying product meets the CFDA national standards. If the applicants cannot find the corresponding national standard/reference material, they can buy the international reference material (USP).

In February 2016, CFDA issued the first edition of “Catalog”. 42 national standard material types are included. In September 2016, after establishing the IVD testing center, CFDA continued to add new national standard IVD based on updating the original types and to keep up with the advancement of the industry. In November 2016, CFDA released the second edition of “Catalog “. The number of standard material was increased to 61.

In the latest edition of “Catalog”, 32 new standard IVDs were added. The total increased to 93. The new catalog enriched the types of national standard materials. As a result, the new catalog should have covered most of the high volume standard reagents and clinically accepted types in infectious disease.

In addition, National IVD Testing Center has developed the national reference NDA for sequencing performance evaluation, national reference peripheral blood fetal chromosome aneuploidy (T21, T18 and T13) for high-throughput sequencing, national reference chromosome aneuploidy before embryo implantation, etc.

For further information about IVD registration and classification, please check out our previous blog or contact us at

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About China Med Device, LLC (CMD) CMD provides turn-key solution for U.S. medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; clinical study and trial design & management; distribution qualification & management; partnership and strategic funding guidance.

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