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Bookmark or Share- China Medical Device Classification Questions - China Med DeviceFormerly named the China Food & Drug Administration (CFDA), the CFDA was established in 1998 to oversee medical devices, drugs and food (as of 2003). In March 2018, CFDA became NMPA with a focus on regulating pharmaceuticals and medical devices.
- NMPA (CFDA) Regulations - China Med DeviceCFDA: November 2, 2017: Download: Decree 6, CFDA, 2014: Regulation on Instructions for Use and Labels of ...
- CFDA’s Requirements for Accepting International Clinical DataAlthough the CFDA is becoming more open to international data, there are a list of considerations to keep in mind, such as the differences of GCP, technical review requirements, trial subjects, and clinical trial conditions between China and foreign countries. This article summarizes CFDA’s guideline for accepting international clinical trial ...
- NMPA Classification Specifications - China Med DeviceIn addition, NMPA (CFDA) may also request manufacturers to provide clinical data along with the device application in China. It is also worth noting that all product information, including what is shown on product packaging and product labeling must be translated and presented in Simplified Chinese.
- CFDA Accelerates Effort in Post Market Surveillance - China Med DeviceNMPA (CFDA), part of SAMR (State Administration of Market Regulation), issued Decree No.1 for Medical Device Adverse Event Reporting and Reevaluation on August 31 st. More control, strictness and timely post-market surveillance will be enforced. Furthermore, for the 1 st time, NMPA (CFDA) imposed severe penalties to the violating companies ...
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