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Change control procedures for R-SUDs with respect to changes to the original medical devices

The Ministry of Health, Labour and Welfare (MHLW) has decided to establish a new system allowing for the reprocessing of single-use medical devices. Accordingly, the relevant laws and regulations are partially amended pursuant to 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), 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), and the “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, the “Standards for Reprocessed Single-use Medical Devices” (MHLW Ministerial Notification No. 261 of 2017) are hereby established. We request your cooperation in circulating the information contained in this Notification to marketing authorization holders (MAHs) of medical devices, etc. under your supervision