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 the test reports submitted as a part of the dossier should be signed and ...

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

PROVIDED that the requirement of Transmissible Spongiform Encephalopathies (TSEs) or ...

For a new in vitro diagnostic medical device: Where relevant to demonstrating conform ...

1.8 Domestic price of the device in the currency followed in the country of origin. ...

7.4 Biological safety: (i) The dossier should contain a list of all materials of anim ...