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 ...

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

Essential principles checklist: (i) The dossier should contain the following:— (a) th ...

Sterilization: (i) Where the device is supplied sterile, the dossier should contain t ...

(B) Such summary information may include: (i) declaration or certificate of conformit ...

22.0 Information required to be submitted for the in vitro diagnostic medical device: ...

(b) conformity with an in-house test method; (c) the evaluation of pre-clinical and c ...