Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41E

What this Part is about

The 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).



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