Points to Consider for Reprocessed Single-Use Medical Devices (Provisional Translation, December 2018)
“…The Ministry of Health, Labour and Welfare (MHLW) has decided to launch a new system to enable the reprocessing of single-use medical devices. In response to this decision, the relevant laws and regulations have been amended in part as specified in the “Ministerial Ordinance for Partial Amendment of the Enforcement Regulations of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (MHLW Ministerial Ordinance No. 82 of 2017), “Ministerial Ordinance for Partial Amendment of the Regulations for Fees related to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (MHLW Ministerial Ordinance No. 83 of 2017), and “Ministerial Ordinance for Partial Amendment of the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In Vitro Diagnostics” (MHLW Ministerial Ordinance No. 84 of 2017). In addition, MHLW has issued “Standards for Reprocessed Single-use Medical Devices” (MHLW Ministerial Notification No. 261 of 2017).”