Analysis on Chinese Government’s Regulation of Medical Devices
In recent years, the National Medical Products Administration (NMPA) is strengthening the formulation and revision of the guiding principles for technical reviews on medical device registration. It released 52 guiding principles in 2016, 79 in 2017 and 64 (including revised ones) in 2018.
On May 28, 2018, the NMPA released the Administrative Norms on Formulating and Revising the Guiding Principles for Technical Reviews on Medical Device Registration to specify the application conditions and responsibilities for the formulating and revising the guiding principles and to further regulate the approval, formulation, review and release of the guiding principles.
On Feb. 25, 2019, the Medical Device Technology Review Center of the NMPA released the 2019 Plan for Formulating the Guiding Principles for Technical Reviews on Medical Device Registration, announcing that it will formulate or revise 86 guiding principles such as the Technical Guidelines for Registration of AI Medical Devices and the Technical Guidelines for Registration of Extracorporeal Synchronized Cardioversion Products.
So far, the NMPA has issued 271 guiding principles, including 109 on active medical devices, 74 on passive medical devices, 75 on exosomatic diagnostic reagents and instruments and 13 on general medical devices. According to CRI’s analysis, there are no guiding principles for several of the 22 categories in the Classified Catalog of Medical Devices issued by the former China Food and Drug Administration in 2017.
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