CMDE Draft Guidelines’ Impact on In Vitro Diagnostic Clinical Trials & Reagents
Prior to 2014, outdated guidelines existed for the conduct of In Vitro Diagnostic (IVD) clinical trials performed in China. To help address these obsolete expectations, the National Medical Products Administration (NMPA) issued what is now considered the current directive to assist with safe and efficacious clinical trial management.
In 2017, the State Council of the People’s Republic of China issued a directive to request feedback regarding the improvement of general requirements, conduct, review and approval of pharmaceuticals, medical devices and IVD products  no. 42 (hall). On 22 November 2018, the Center for Medical Device Evaluation (CMDE) developed draft guidelines, “Technical Guiding Principles for Clinical Trials of In Vitro Diagnostic Reagents,” to secure opinions pertaining to the draft guidelines for the oversight and conduct of IVD clinical trials.
The objective of this White Paper is to provide information to manufacturers who intend to perform IVD clinical trials in China, including newly proposed regulatory and clinical guidelines. A few of these modifications include:
- Class 2 and Class 3 products are expected to engage with at least three study sites for clinical trials.
- More prospective samples will be required for use, while the use of retrospective samples will be discouraged.
- Sample size estimates will be required to be statistically determined, as opposed to arbitrarily assigned.
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