. The applicant shall provide and maintain suitable equipment having regard to the na ...

DUTIES AND FUNCTIONS OF NOTIFIED BODY 1. Duties: 1. Notified body shall perform the a ...

DUTIES OF MEDICAL DEVICE OFFICER, MEDICAL DEVICE TESTING OFFICER AND NOTIFIED BODY 6 ...

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

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

3. Procedure for audit: The notified body shall carry out the audit in the following ...

(b) the modification of a medical device and in vitro diagnostic medical devices; (c ...

(v) "intended use" means the use for which the medical device is intended according t ...