Section 11
Requirement for registration of conformity assessment body
No conformity assessment body may carry out any conformity assessment related to a medical device unless it is registered under this Act.
(2)
A conformity assessment body may apply for registration by submitting a written application to the Authority in the prescribed manner.
Medical Device 17
(3)
An application may be withdrawn at any time by the applicant before it is approved or refused by the Authority.
(4)
Every application under subsection (1) shall be accompanied by the prescribed application fee and such document or information as may be specified by the Authority.
(5)
The Authority may, in writing, at any time after the receipt of an application under subsection (2), request the applicant to give to the Authority within the period specified in the request additional information, particulars or document on the application.
(6)
If any additional information, particulars or document required under subsection (5) is not given by the applicant within the period specified in the request or any extension of time granted by the Authority, the application shall be deemed to be withdrawn and shall not be further proceeded with, but without affecting the right of the applicant to make a fresh application.