Grace Fu Palma, founder and CEO of Boston-based China Med Device, LLC, a firm specializing in commercialization and funding for medtech companies entering China, considers CFDA’s proposal for exempting certain IVD reagents from clinical trials.
On May 24, CFDA issued a draft document on clinical evaluation basic requirements for clinical exempt IVD reagents, adding a second batch of clinical exempt class II IVD reagents — 130 reagents — to the agency’s directory.
Key provisions in the draft include the clinical evaluation comparison method, sample selection and sample size, and the content of the clinical evaluation report.
The exempt IVD reagents will need a clinical performance evaluation based on the assessment of the intended use, interference factors, a comprehensive literature review and other non-clinical-trial elements to get products approved by CFDA.
The document includes the following key provisions:
Clinical Evaluation Comparison Method
Sample Selection and Sample Size
Basic Content of the Clinical Evaluation Report
Areas that need special attention:
In summary, although the listed IVDs would be exempt from clinical trials, CFDA will require sponsors to assemble a significant amount of data and supporting information to get products approved. — Grace Fu Palma | firstname.lastname@example.org (978) 390-4453 www.chinameddevice.com