China Med Device
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China Med Device specialize in accelerating Western medtech companies with turn-key solutions for China FDA regulatory & CRO services and commercialization. Get daily updates about China medtech market assessment, CFDA regulation, China funding oppotunies.
China Med Device
4d ago
The NMPA granted innovation approval to Ivantis, Inc.’ hydrus microstent and issued a review report. This is the fifth report published for overseas manufacturers, after Medtronic, CarboFix Orthopedics, Intuitive Surgical […]
The post NMPA Review Report Released for Ivantis’ Hydrus Microstent appeared first on China Med Device ..read more
China Med Device
6d ago
NMPA issued the clinical trial audit result for an IVD manufacturer on April 16, 2024. The audited firm is Guangdong Hexin. Its Respiratory Syncytial Virus, Influenza A Virus, Influenza B […]
The post Authenticity Issues Found in Clinical Trial Audit appeared first on China Med Device ..read more
China Med Device
2w ago
NMPA published the “2024 Medical Device Guidelines Revisions Plan” today on April 11, 2024, in which 49 guidelines for Class III and 60 for Class II devices are affected. The […]
The post NMPA: 49 Class III Devices Impacted by 2024 Guidelines Revisions Plan appeared first on China Med Device ..read more
China Med Device
2w ago
“Quality Management Practice Specification for Clinical Trials of Medical Devices (so called China GCP)”, implemented from March 2022, specifies that “Clinical trial sites must be on the NMPA filed institutions […]
The post 1380 Institutes Certified to Conduct Clinical Trials in China appeared first on China Med Device ..read more
China Med Device
2w ago
NMPA published the “Medical Devices Usability Engineering Guideline” on March 19, 2024. Below is the “Interpretation on Device Usability Engineering Guideline” issued on March 27, 2024. For the first batch […]
The post NMPA Interpretation on Device Usability Engineering Guideline appeared first on China Med Device ..read more
China Med Device
3w ago
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in April 2024. These updates are presented by China Med Device, LLC, your partner […]
The post NMPA Roundup April 2024 appeared first on China Med Device ..read more
China Med Device
3w ago
NMPA published the “Medical Devices Usability Engineering Guideline” on March 19, 2024. NMPA believes that, in improving the usability and the design of devices to minimize potential use errors and […]
The post NMPA Usability Engineering Guideline Issued for Medical Devices appeared first on China Med Device ..read more
China Med Device
1M ago
NMPA issued the draft version of “2024 Medical Device Industry Standards Revisions Plan” on March 22, 2024, with the deadline for feedback on March 29. The plan proposes 8 mandatory […]
The post Eight Mandatory and Ninety Recommended Standards to be Revised in 2024: Revisions Plan Asks Your Feedback appeared first on China Med Device ..read more
China Med Device
1M ago
NMPA announced the “2024 National Inspection Plan for Medical Devices” today on March 19, 2024. The Plan asks provincial NMPA offices and testing centers to conduct quality inspections based on […]
The post 2024 National Inspection Plan Released Today: Pay Attention to Your Device Standards appeared first on China Med Device ..read more
China Med Device
1M ago
NMPA announced the “Measures for Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)” on March 12, 2024, for feedback, along with the inspection checkpoints and judging principles. Feedback […]
The post Guidance Reveals How NMPA Inspects Your Clinical Trial Institution appeared first on China Med Device ..read more