On April 3, 2024, CMDE issued a notice to publicly solicit participating companies in the medical device clinical evaluation industry standard formulation project.
Standards to be initiated or modified in 2024：
- Medical Device Real World Data Terminologies and Definitions
- IVD reagent clinical trial biological sample management requirements
Qualification for the applicants:
- Have independent legal personality；
- Have work background and technical capabilities related to research, production, management and other projects related to the formulation and revision of standards;
- Be familiar with relevant national medical device policies, regulations, and standards, and be familiar with the work process of formulating and revising medical device standards;
- Ability to fully participate in standard formulation and revision work and complete assigned tasks.
Companies interested in participating in the compilation work are requested to fill in the “2024 Medical Device Clinical Evaluation Industry Standard Participating Unit Registration Form” and submit it before April 17, 2024.