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New Clinical Trial Exemption List
On 30.09.2018, the NMPA published a revised “Clinical Trial Exemption List for Medical Devices and IVDs”, which was immediately implemented (NMPA No. 94-2018). 63 Class II and 21 Class III medical devices, 246 Class II and 31 Class III IVDs were added. The new clinic trial exemption list now contains a total of 855 medical devices and 393 IVDs.
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