Two Cases of Plantar Keratosis Successfully Improved by Intake of Food Containing Hot Water Extract of Coix lacryma-jobi L. var. ma-yuen Stapf with Husks / 日本補完代替医療学会誌

We reported 2 cases of plantar keratosis (59 years of age, female/39 years of age, male) successfully improved by intake of hot water extract of Coix lacryma-jobi L. var. ma-yuen Stapf with Husks. Both subjects were administered coix seed extract containing food for 20 weeks. The lesions improved gradually after 12 weeks, and almost cured by 20 weeks of administration. Although the food seemed to be effective in these cases, further studies are needed to define the optimal dose and duration.

Brief Introduction about New Regulation of EU on IVDR / 中国医疗器械杂志

There are five-year transitional period for manufacturers after the issue of regulation(EU) 2017/746 on

Enlightenment on Carrying out Reporting Responsibility of Manufactures in China from Reviewing Medical Device Reporting Practice in US / 中国医疗器械杂志

OBJECTIVE@#By introducing the Medical Device Reporting (MDR) system and related inspection practice of the US, this paper puts forward some suggestions on implementing reporting responsibility of manufactures in China.@*METHODS@#The MDR system and the related inspection system in the US were systematically analyzed.@*RESULTS@#The US had established a sound system for discovering and reporting MDR, and a mechanism for inspecting the implementing of manufactures, forming an effective post-market surveillance system.@*CONCLUSIONS@#By learning from the experience of the US, we can carry out the post-market surveillance of medical devices adverse events in China from the aspects of implementing the existing system, strengthening the reporting ability and perfecting the inspection mechanism.