1.2 Information regarding sterilization of the device (whether it is sterile or non-s ...

3.13 Quality audit means a systematic, independent examination of a manufacturer's qu ...

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

Test or evaluation of sample under sub-section (4) of section 25 of the Act-(1) The s ...

Performance evaluation report from a laboratory designated under subrule (1) of rule ...

(b) If the in vitro diagnostic medical device contains any of the following then desc ...

APPLICATION FOR GRANT OF LICENCE TO MANUFACTURE FOR SALE AND DISTRIBUTION OF CLASS A ...

UNDERTAKING BY THE INVESTIGATOR 1. Full name, address and title of the Principal Inv ...