Medical device science popularization and education is a long-term and important task

With the growing public demand for health and disease prevention services, there is a rising awareness of the quality and safety of diagnostic reagents used in healthcare. There are increasing demands for transparency and quality control regarding the comparability of test results for the same item across different hospitals and at different times within the same hospital.

With the growing public demand for health and disease prevention services, there is a rising awareness among the public regarding the quality and safety of diagnostic reagents used in healthcare. There are increasing demands for transparency and quality control regarding the comparability of test results for the same item across different hospitals and at different times within the same hospital.

Simultaneously, with the development of self-testing products, more and more in-vitro diagnostic reagents are entering homes, such as early pregnancy tests and blood glucose monitoring. This use brings many differences in understanding and problems in application. There are many needs for knowledge dissemination and risk control in aspects such as product selection, storage, use, and disposal, making it increasingly necessary to develop rich and diverse relevant science popularization and publicity.

While strengthening medical device supervision, conducting quality assessments, and increasing the intensity of comprehensive governance, the National Medical Products Administration (NMPA) attaches great importance to medical device science popularization and education. Working closely with the China Pharmaceutical News and Information Association, it leverages the strengths of social organizations, experts, and the media to develop and compile a series of educational materials on medical devices. These materials are provided for use by food and drug regulatory agencies and media at all levels to conduct science popularization and publicity. The goal is to help the public correctly understand medical devices such as in-vitro diagnostic reagents, avoid misconceptions and misuse, improve awareness of quality and safety, effectively share the fruits of social development and technological progress, and improve the quality of medical device supervision, promoting healthcare capabilities and overall health levels, and fostering social co-governance.

Currently, most in-vitro diagnostic reagents in China are regulated as medical devices, while some are regulated as pharmaceuticals. The science popularization knowledge introduced here mainly refers to the concepts, regulatory policies and regulations, correct selection, correct understanding of advertising, and the use and maintenance of self-use products related to in-vitro diagnostic reagents managed as medical devices. "50 Questions about In-Vitro Diagnostic Reagents" is an important component of the medical device series of science popularization materials and provides guidance and assistance to readers in understanding, correctly recognizing, and using in-vitro diagnostic reagents.

Medical device science popularization and education is a long-term and important undertaking. We sincerely hope that all sectors of society will pay close attention and participate widely to jointly improve and advance!