Category: NMPA (CFDA) Updates

The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities

The CMDE published a revision of the supplement phase on February 20, 2023, suggesting that it is ending Covid measures on medical device registration. The

The NMPA released ninety-four review reports in 2022. Three categories of approvals are included: innovation, priority review and Class III predicate-comparison devices. Overseas manufacturers including

The NMPA issued four draft guidelines today on September 28, 2022, soliciting public opinions. Your NMPA guidelines feedback needs to be submitted by October 14,

The NMPA released the draft version of “Registration Guideline for Radio Frequency Aesthetic Devices” on August 26. 2022 for feedback. Opinions need to be submitted

Here are the latest China NMPA Regulatory and Clinical Affairs news for medical device and IVDs pros for July 2022. These updates are presented by

The NMPA released the “Guideline for Fundamental Principles Compliance of Medical Device Safety and Performance”, elaborating the risk-based approach for medical device registration review. Article

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in June 2022. These updates are presented by China

The NMPA released 55 revised or newly established medical device standards on May 18, 2022, with indications ranging from cardiovascular, plastic surgery, oncology, clinical chemistry

Here are the latest China regulatory and clinical affairs news pieces for medical devices and IVDs in February 2022. These updates are presented by China