Control of monitoring and measuring devices The manufacturer shall determine the moni ...

(viii) when any major non-compliance is observed during audit by the notified body wh ...

Vulnerable population (a) Description of the vulnerable population. (b) Description o ...

THIRD SCHEDULE [Refer rules 13(5), 13(9), 14, 15, 20(4), 20(6)] DOCUMENTS REQUIRED FO ...

10.0 Analytical sensitivity: This section should include information about the study ...

7.7 Animal studies: (i) Where studies in an animal model have been undertaken to prov ...

14.0 Definition of Assay Cut-off: This section should provide a summary of analytical ...

Control of design and development changes: Design and development changes shall be id ...