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2024 China NMPA Bluebook is here:
NMPA granted innovation approvals to seven devices in December 2023, for indications ranging from cardiovascular, orthopedic, immunology and urology. Among them are two imported devices. Complete List There have been
NMPA conducted on-site quality inspection on eleven types of medical devices and released the result on December 18, 2023. Eighteen manufacturers are found incompliance, including three overseas companies. Companies Found
In October 23, a total of 221 medical device products were approved by China National Medical Product Administration (NMPA). Among them, there are 176 domestic Class III medical device products,
NMPA issued four draft clinical guidelines on December 11, 2023. Feedback needs to be submitted by January 2, 2024. For an English copy of any guideline below, please email info@ChinaMedDevice.com.
As we eagerly anticipate the 14th China International Medical Device Regulatory Forum (CIMDR) from March 30 to April 4, 2024, we find ourselves reflecting on the invaluable insights gained from
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in November 2023. These updates are presented by China Med Device, LLC, your partner
NMPA issued the “Key Points and Principles for Medical Device Clinical Trial Inspections (Draft) on November 28, 2023. Feedback needs to be submitted by December 31, 2023. It proposed to
The NMPA granted Innovation Approval to five medical devices in November 2023, including two additive manufactured devices: For an English copy of the “Tech Guide on Customized Additive Manufactured (3D
Eighteen newly-established or revised industry standards were released by NMPA on November 24, 2023, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. Mandatory Standards Recommended Standards
The NMPA granted innovation approvals to Zap Surgical’s head and neck X-ray stereotactic radiosurgery system and issued a review report. It is the seventh imported innovative device approved by the
NMPA conducted quality inspection on eleven types of medical devices and released the result on November 14, 2023. Twenty manufacturers are found incompliance, including three overseas companies making soft contact
The NMPA issued the innovation approval review report for Varian’s Proton Therapy System. It is the seven imported innovative device approved by the NMPA so far in 2023, after Medtronic,
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