New IVD Reagent Registration and Filing Rules Take Effect in China

by Grace Wang Oct 08, 2021

On Aug. 26, China's State Administration for Market Regulation (SAMR) promulgated the Administrative Measures for In Vitro Diagnostic Reagent Registration and Filing1 (hereafter referred to as the Measures)

SAMR released the Administrative Measures for Medical Device Registration and Filing on the same day. The two measures resemble each other in their contents. The implementation dates are both on Oct. 1, 2021.

However, there are still noteworthy rules particular to IVD reagent registration and filing. This article is meant to help stakeholders grasp them.

This article's content is as follows:

  1. The Measures' Application Scope;

  2. Definition of IVD Reagents in China;

  3. IVD Reagent Classification in China;

  4. Definition and Application Scope of IVD Reagent Registration/Filing in China;

  5. Qualification of Registration/Filing Applicant and Local Agent;

  6. Competent Authority to Submit Application/Documentation to;

  7. Documentation for IVD Reagent Registration Application/Filing;

  8. Special Approval for IVD Reagents;

  9. Product Change and Certificate Validity Extension;

  10. Adjusting the Class of Registered IVD Reagents.

Grace Wang
ChemLinked Regulatory Analyst
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