Publication policy (a) Statement indicating whether the results of the clinical inve ...

Cover page or login screen (1) Name of sponsor or sponsor logo. (2) Clinical investig ...

Procedural issues A system shall be established to enable cross-referencing of CRFs a ...

Recall detail Footnotes i Type of Product: Medicine, Medical Device, or Biological ii ...

2. Bio-compatibility tests data, Report of bio-compatibility tests along with rationa ...

(f) Undertaking signed stating that the manufacturing site is in compliance with the ...

17.0 In use stability: This section should provide information on in use stability st ...

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