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Tag: Innovation Approval

NMPA Review Report Released for Ivantis’ Hydrus Microstent

The NMPA granted innovation approval to Ivantis, Inc.’ hydrus microstent and issued a review report. This is the fifth report published for overseas manufacturers,...

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NMPA Review Report Released for Varian’s Proton Therapy System

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...

Varian’s Proton Therapy System Gains NMPA Innovation Approval

NMPA granted innovation approval to Varian’s Proton Therapy System on November 1, 2023. What’s the Device This product consists of an accelerator subsystem and...

NMPA Roundup October 2023

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in October 2023. These updates are presented by...

Siemens’s X-ray CT Gains NMPA Innovation Approval

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...

NMPA Roundup September 2023

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in September 2023. These updates are presented by...

AI Infused Software as a Medical Device (SaMD) for Ischemic Stroke Detection Approved in China

The NMPA granted innovation approval to Ischemic stroke CT image assisted assessment software and released the review report in July 2023. This software is...

NMPA Roundup June 2023

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in June 2023. These updates are presented by...

Two Devices Gain Innovation Approval in One Day

NMPA granted innovation approvals to two devices on June 20, 2023. Zap Surgical: Head and neck X-ray stereotactic radiosurgery system Beijing Shurui: Laparoscopic single-port...

NMPA Review Report Released for Corindus’s Coronary Surgery Control Accessories

On May 16, 2023, the NMPA granted innovation approval to Corindus Inc., for its coronary interventional surgical control system accessories. It is the fifth...

NMPA Roundup May 2023

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in May 2023. These updates are presented by...

Imported Intravascular Imaging Equipment Gains Innovation Approval

On May 16, 2023, NMPA granted innovation approval to Conavi Medical Inc., from Canada, for its intravascular imaging system. It is the fourth imported...

NMPA Roundup April 2023

Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in April 2023. These updates are presented by...

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