Note: 1. All the test reports submitted as a part of the dossier should be signed and ...

Note: 1. All the test reports submitted as a part of the dossier should be signed and ...

Clinical evidence: The dossier should contain the clinical evidence that demonstrates ...

Note: 1. All reports submitted as a part of the dossier should be signed and dated by ...

Information required to be submitted for the in vitro diagnostic medical device: (1) ...

(3) In case of imported diagnostic in vitro diagnostic medical devices, the report of ...

Design and development verification: Verification shall be performed in accordance wi ...

7.3.6 Design and development validation: Design and development validation shall be p ...