ABSTRACT
China's Class 1 medical devices whose applications for filing were accepted in Anhui Province drug licensing system from January 2021 to December 2022 in some city of Anhui Province were used as the study object.The problems were analyzed in filing application,review and filing materials.It's suggested that the filer pay attention to the definition of medical devices,specifications for compiling filing materials,rigor of filing materials and whole-process quality management of medical device filing.References were provided for Class I medical device filer to standardize filing application materials and regulatory authorities to strengthen in-process and ex-post supervision of Class I medical device filing.[Chinese Medical Equipment Journal,2023,44(11):90-94]
ABSTRACT
An analysis method for requirement of medical consumptive materials on Kalman filter is put forward.An analysis mathematical model is established at first,its solution process is carried out at same time,and then an example using this solution is given according to the working practice.At last,the shortcomings using classical Kalman filter were discussed and a new method using adaptive Kalman filter was proposed.