[Overview of Status of Medical Device Registration and Quality Evaluation Requirements for Clinical Mass Spectrometry].

Mass spectrometry technology is becoming an important tool for clinical analysis due to its high specificity, high sensitivity and high multi-component detection capability. The current applications of this technology are mainly in liquid chromatography-tandem mass spectrometry (LC-MS/MS), matrix-assisted laser desorptionionization time-of-flight mass spectrometry (MALDI-TOF-MS), inductively coupled plasma mass spectrometry (ICP-MS), gas chromatography-mass spectrometry (GC-MS) and the related in vitro diagnostic kits. At present, the number of medical device (MD) based on mass spectrometry technology is growing rapidly, especially the number of LC-MS/MS and MALDI-TOF-MS registered MD products, and the standardization of relevant product quality requirements is also being effectively carried out. In general, clinical mass spectrometry equipment is still mainly imported, and the equipment price is relatively high. The development of mass spectrometry kits is mainly based on imported platforms, and domestic equipment is still in its infancy; the further promotion of clinical application of mass spectrometry also depends on the progress of the automation and standardization of the analysis procedure. To investigate the detection performance of mass spectrometry systems, it is necessary to fully consider the characteristics of mass spectrometry technology itself.

[Research on the Standardization System of In Vitro Diagnosis Products at Home and Abroad].

OBJECTIVE: The quality of in vitro diagnostic products is closely related to people's health. The standards and standardization system are essential to IVD industry and supervision. METHODS: Through a study of the standards of ISO, EU, the USA and China, a comparative analysis was carried out. RESULTS: China's IVD standardization system is different from other organization in terms of standard quantity, type and content. The standardization system has its own characteristics, and conforms to the current industrial characteristics and regulatory needs. CONCLUSIONS: Some suggestions are put forward to provide references for strengthening supervision of IVD products.