NMPA and China Health Commission issued the "Quality Management Practice Specification for Clinical Trials of Medical Devices", effective May 1, 2022.
Key Changes for China NMPA Clinical Trial Compared to the China GCP published in 2016, new updates are:
- Changed from 96 articles in 11 Chapters to 66 articles in 9 Chapters.
- Integrated IVD into new GCP NMPA Clinical Pathways.
- Clarified responsibilities of the relevant parties in clinical trials of medical devices.
- Modified SAE reporting process:
- The "double report" is changed to "single report"
- The scope of the report is determined as the serious adverse events related to the investigational medical devices
- The reporting time limit for death or life-threatening: < 7 days for death or life threatening, other SAEs < 15 days
- Simplified the requirements and approval process
Love to hear your feedback and experience on China clinical trial. The best is to avoid a China clinical trial. Post Order 739, more and more local trials could be minimized with overseas clinical and none-clinical evidence support. Please let us know if you need an English version of "Quality Management Practice Specification for Clinical Trials of Medical Devices" and any documents that NMPA issues as Annexes, please email info@ChinaMedDevice.com.
- Model Clinical Trial Protocol for Medical Devices
- Model Clinical Trial Report for Medical Devices
- Model Clinical Trial Protocol for In Vitro Diagnostic Reagents
- Model Clinical Trial Report for In Vitro Diagnostic Reagents
- Severe Adverse Event Report Form for Clinical Trials of Medical Devices/In Vitro Diagnostic Reagents
- Catalogue of Basic Documents for Clinical Trials of Medical Devices/In Vitro Diagnostic Reagents
The "China GCP" covers the whole process of medical device clinical trials, including the design, implementation, supervision, inspection, data collection, recording, preservation, analysis, summary, and reporting.
Reflecting the latest international requirements, the "Specification" refers to the documents of the International Medical Device Regulators Forum (IMDRF), such as MDCE WG/N57 FINAL: 2019, and introduces the concept of multi-regional clinical trials in different countries or regions to facilitate market access of imported innovative products.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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