Q: When the contents of the mandatory standards cited in the technical requirements of registered medical devices (in vitro diagnostic reagents) change, under what circumstances does it not need to go through the change registration？ more…
I.Product performance
One of the requirements of in vitro diagnostic instruments different from other medical devices is that clinical project analysis performance research should be carried out. Considering the situation of the detected substances and the main functions of the product (for example, quantitative / qualitative analysis, different detection methods / modes, etc.), representative items are selected for research according to different types of analytes and different functions of the instrument. it should be repeated many times and include the process of confirmation and verification. Research items generally include accuracy, repeatability, linearity, stability, carrying pollution and so on. more…
I.General situation
In 2021, China’s total foreign trade in medical devices reached 134.94 billion US dollars, a year-on-year decrease of 18.8%. Among them, the import volume was US $50.21 billion, a year-on-year increase of 18.4%; the export volume was 84.73 billion US dollars, a decrease of 31.5%. more…
In January 2022, the National Health Commission, NMPA, NIFDC and other departments successively issued a number of policies, regulations, notices and announcements for the medical device industry (including IVD industry). In order to facilitate the inquiry of people in the industry and provide clear, fast and effective services, we have collected and sorted these documents in a centralized manner. The directory is as follows: more…
In order to strengthen the supervision and guidance of medical device product registration and further improve the quality of registration review, according to the Administrative Measures for Registration and Filing of Medical Devices (Order No. 47 of the NMPA), NMPA has organized and formulated relevant technical guidelines. more…
