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

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

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

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

4.2.3 Control of documents : Documents required by the quality management system shal ...

(g) "body orifice" means any natural opening in a human body including the external s ...

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

Definitions In these rules, unless the context otherwise requires, — (a) "academic cl ...