Today, in line with the work plan of the National Medical Device Clinical Evaluation Standardization Technology Centralized Unit for standard formulation in 2023, the unit has finalized two industry standard solicitation drafts. These drafts are titled "Quality Technical Specifications for Clinical Trials of Medical Devices" and "Quality Technical Specifications for Clinical Trials of In Vitro Diagnostic Reagents". The unit has commenced the public solicitation of feedback and opinions from the wider society.
Here's the information regarding the public solicitation of opinions for the two industry standard solicitation drafts:
Clinical Trials of Medical Devices - Quality Technical Specifications:
name | Proposed implementation date | Contact | Deadline for Feedback |
Quality technical specifications for clinical trials of in vitro diagnostic reagents | Implemented 12 months after release | Liu Lu Phone: 010-86452501 Email: liulu@cmde.org.cn | Before October 31, 2023 |
Quality Technical Specifications for Clinical Trials of In Vitro Diagnostic Reagents | Implemented 12 months after release | He Jingyun Phone: 010-86452544 Email: hejy@cmde.org.cn | Before October 31, 2023 |
If you have any comments or feedback on these drafts, please provide them via email before the specified deadline. Your input is valuable in ensuring the quality and effectiveness of these industry standards.