(1) This section applies if an application under subsection 41FC(1) for a kind of medical device to be included in the Register:
(a) is refused under subsection 41FDB(4); or
(b) is refused under subsection 41FF(1A).
(2) The Secretary must notify the applicant in writing, of the refusal within 20 working days after the application has been received and the prescribed application fee has been paid.