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Ordinance on Standards for Manufacturing Control

(2) Amended Enforcement Regulations “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” (MHW Ministerial Ordinance No. 1 of 1961) amended according to “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) (3) Amended Fee Regulations “Fee Regulations related to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (MHW Ministerial Ordinance No. 63 of 2000) amended according to the “Ministerial Ordinance for Partial Amendment of the Fee Regulations 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) (4) Amended QMS Ministerial Ordinance “Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In Vitro Diagnostics” (MHLW Ministerial Ordinance No. 169 of 2004) amended according to “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) (5) Reprocessing Standards “Standards for Reprocessed Single-use Medical Devices” (MHLW Ministerial Notification No. 261 of 2017) (6) Single-use medical devices (SUDs) Medical devices designed to be used only once (7) Reprocessing Operations related to product inspection, disassembling, cleaning, sterilization treatment, and other appropriate necessary processing in advance of the manufacturing and distribution of used SUDs (8) R-SUDs Single-use medical devices that were reprocessed (9) Original medical devices SUDs that are intended to be reprocessed and have not been previously reprocessed.