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2025 China NMPA Bluebook is here:
NMPA published 54 draft guidelines on October 25, 2023, for feedback. Feedback needs to be submitted by November 23, 2023. Significance of Device Guidelines The guidelines are prepared by NMPA
NMPA granted innovation approval to Siemens’s X-ray computed tomography equipment on October 17, 2023. What’s the Device In the approval notice, NMPA says that “the product consists of a scanning
On May 16, 2023, the NMPA granted innovation approval to Conavi Medical Inc., from Canada, for its intravascular imaging system. It is the fourth imported innovative device approved by the
48 AI independent software have been approved so far, according to work summary of Artificial Intelligence Medical Device Innovation Cooperation Platform that NMPA CMDE established in July 2019. The notice
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 of Guangdong province: Guangzhou, Shenzhen,
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 notice says that: Guideline on
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 Boston Scientific, Edwards Lifesciences, Uptake
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, 2022. NMPA Guidelines Feedback Requested
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 by September 18, 2022. The
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 China Med Device, LLC, your
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 13 of “Administrative Measures for
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 Med Device, LLC, your partner
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