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Regulations & Services of PMDA
Information about Approved Products in Japan
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Information for approved products in Japan
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Development of Drugs, Medical devices, Regenerative medicines and in Vitro diagnostics
Information for approved products in Japan
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Regulations and services of PMDA
Information for approved products in Japan
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Regulations and Services of PMDA
Information for apporoved products in Japan
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Regulations and Services of PMDA
Information for apporoved products in Japan
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Reviews and Related Services
Post-marketing Safety Measures
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Reviews and Related Services
Post-marketing Safety Measures
Regulatory Science/The Science Board/Standard Development
The 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
Press Release
February 20, 2023 from 2pm to 4pm
Given the impact of COVID-19, the conference was held online.
Agenda / List of Handouts
Agenda
- Study on Issue of Report
- Way of Reuse of Data
- Terms Required for Data Assessment
- Way of Examination of Adaptive AI
- Others
List of Handouts
- Document 1 Summary of Discussions at the 3rd Working Group
- Document 2 Script of Post-market Change of Performance
- Document 3 Topic Note of Discussion (January 23, 2023)
- Document 4 Modality-specific Situation of Database
- Document 5 Agenda and Draft of Report (Repost of the 3rd Subcommittee)