THERAPEUTIC GOODS ACT 1989 - SECT 41E What this Part is about
THERAPEUTIC GOODS ACT 1989 - SECT 41E
What this Part is aboutThe Secretary can issue a conformity assessment certificate (which may be limited to some medical devices) in respect of a manufacturer of medical devices, signifying one or more of these:
(a) that relevant quality management systems have been applied to the device;
(b) the essential principles for the device have been complied with;
(c) other certification requirements of the conformity assessment procedures have been met.
Note: A conformity assessment certificate may be required for an
application to include a kind of medical device in the Register to pass
preliminary assessment: see paragraph 41FDB(2)(e).