Criteria for in vitro diagnostics
yCertification Criteriaz
[Scope]
|
PDF|
PDF|PFSB Notification No. 0120-4: 2015/01/20
PSEHB Notification No. 0723-1: 2018/07/23
PSEHB Notification No. 0402-1: 2019/04/02(Last Updated)
[Technical Standards]
|PDF|
PDF|PFSB Notification No. 0120-4: 2015/01/20
[Essential Principle Checklist]
|PDF|
PDF|PFSB/ELD/OMDE Notification No. 0120-1: 2015/01/20
PSEHB /ELD/OMDE Notification No. 0818-2: 2021/08/18 (Last Updated)
yApproval Criteriaz
[Scope]
|PDF|
PDF|PFSB Notification No. 0120-1: 2015/01/20
PSEHB Notification No. 0510-2: 2019/05/10 (Last Updated)
[Technical Standards]
|PDF|
PDF| PFSB Notification No. 0120-1: 2015/01/20
[Essential Principle Checklist]
|PDF|
PDF|PFSB/ELD/OMDE Notification No. 0120-1: 2015/01/20
PSEHB Notification No. 0222-5: 2016/02/22
PSEHB /ELD/OMDE Notification No. 0818-2: 2021/08/18 (Last Updated)
yCriteria for exemption of Approval or Certificationz