(iv) the manufacturer shall self-certify that the product is conforming to the essent ...

(1) "clinical investigation" means the systematic study of an investigational medical ...

(ii) Documents to be submitted with the application for grant of licence to manufactu ...

The manufacturer shall ensure that changes to documents are reviewed and approved eit ...

(ii) Directors, executives and personnel responsible for carrying out evaluation and ...

(vi) Other in vitro diagnostic medical devices (a) An in vitro diagnostic medical dev ...

Important information on the System for Australian Recall Actions The TGA publishes i ...

7.0 Verification and validation of the medical device 7.1 General: (A) The dossier sh ...