Regulatory Science Activity Report (FY 2023)

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Confirmation of compliance with Article 12, Paragraph 3 of the Essential Principles for Medical Devices, PSEHB/MDED Notification No. 0523-1, by Director of the Medical Device Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare on May 23, 2023 https://www.mhlw.go.jp/content/11120000/001203129.pdf Q & A for Application of Article 12, Paragraph 3 in the Criteria for Essential Principles of Medical Devices, PSEHB/MDED Administrative Notice, issued by Director of the Medical Device Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare on July 20, 2023 https://www.pmda.go.jp/files/000263421.pdf(in Japanese) Basic Principles for Adverse Events Reporting Regarding Cybersecurity of Medical Devices, PSB/PSD Notification No. 0115-2, issued by Director of Pharmaceutical Safety Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare on January 15, 2024 https://www.pmda.go.jp/files/000272598.pdf Q & A for Medical Device Cybersecurity, Administrative Notice issued by Office of Counsellor for Assistance for Development of Specified Drug and Medical Information Management, Health Policy Bureau, Ministry of Health, Labour and Welfare, Medical Device Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare, Pharmaceutical Safety Division, Ministry of Health, Labour and Welfare, and Compliance and Narcotics Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare, on January 31, 2024 https://www.pmda.go.jp/files/000269643.pdf(in Japanese) Management of Vulnerabilities to Ensure Cybersecurity of Medical Devices, PSB/MDED Notification No. 0328-1, PSB/PSD Notification No. 0328-3, issued by Director of Medical Device Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare and Director of the Pharmaceutical Safety Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare on March 28, 2024 https://www.pmda.go.jp/files/000272597.pdf Medical Device International Affairs WG Clarification of points on confirmation of compliance with Article 12, Paragraph 3 of the Essential Principles for Medical Devices Q & A for Confirmation of compliance with Article 12, Paragraph 3 of the Essential Principles for Medical Devices Clarification of points on adverse event reports by marketing authorization holders regarding medical device cybersecurity Q & A for Medical Device Cybersecurity including the application, etc. of Article 12, Paragraph 3 of the Essential Principles for Medical Devices Clarification of points to consider about vulnerability management for cybersecurity of medical devices, etc. for smoothly securing the system under marketing authorization holders of medical devices 12