Guidance for License Holder on Collecting and Reporting Individual Cases of Medical Device Adverse Event

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  • Create Date September 20, 2018
  • Last Updated January 6, 2022

Guidance for License Holder on Collecting and Reporting Individual Cases of Medical Device Adverse Event

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File
Decree 1 Annex 5 Collection and Reporting of Medical Device Adverse Events for Marketing Authorization Holder Guiding Principles draft