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CFDA to Exempt 130 In-Vitro Tests From Clinical Trials

June 6, 2017

China’s Food and Drug Administration is proposing to exempt 130 kinds of in-vitro diagnostic tests from clinical trial requirements.

The CFDA included the proposal as part of a draft rule for clinical development of IVD tests that are not eligible for exemption. The preliminary list of exempt tests includes reagents used to detect biomarkers such as hemoglobin, troponin and C-reactive protein, which are used to detect heart attacks, inflammation and anemia.

China has historically granted few exemptions for such devices, creating a heavy burden for companies forced to generate the trial data.

The CFDA also issued a document establishing the process for IVD testing, including selecting reference methods and sample sizes and the preparation of evaluation reports. The agency invited comments on both drafts through the end of June.

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