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

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

“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

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

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

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

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

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

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

NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” today on March 18, 2024. The document suggests manufacturers how to choose predicate device comparison or clinical trial […] The post 21 Class III Devices Exempted for Clinical Trial: Faster Market Access for Surgical Equipment in Cardio, Neuro, Ortho, Aesthetic and Dental Applications appeared first on China Med Device ..read more