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
This article collected the statistics of Shanghai's class II passive medical device registration filing review trial implementation. It summarized and analyzed the common issues in the filing review stage, and gave suggestions for registration applicants and reviewers in order to further improve the quality of application materials and improve the efficiency of review.