Performance evaluation report from a laboratory designated under subrule (1) of rule 19. (4) The Central Licensing Authority may, in public interest, abbreviate, defer, or waive the requirements of conducting clinical performance evaluation for reasons to be recorded in writing for grant of permission to conduct clinical performance evaluation. (5) If the Central Licensing Authority, after such further enquiry, if any, as may be considered necessary, is satisfied that the requirements of these rules have been complied, may grant permission to conduct clinical performance evaluation for a new in vitro diagnostic medical device in Form MD-25 or may reject the application, tor reasons to be recorded in writing, within a period of ninety days from the date of application.