the device complies with the Essential Principles and the manufacturer has available sufficient information to substantiate that compliance with the Essential Principles or have procedures in place, including a written agreement, to ensure that such information can be obtained from the manufacturer within 20 working days an appropriate conformity assessment procedure has been applied to the device the sponsor has available sufficient information to substantiate the application of those conformity assessment procedures or have procedures in place to ensure that such information can be obtained from the manufacturer within 20 working days any advertising material relating to the medical device complies with the TGA requirements—for more information see Advertising in Section 12. Information about a medical device. the device does not contain substances that are prohibited imports under the Customs Act the device is not an excluded device The sponsor has ongoing responsibilities once a device has been included in the ARTG. The Act requires that the sponsor will: Requirement Example(s) Legislative reference Allow entry and inspections of premises allowing a person authorised by the TGA to enter and inspect any premises, including outside , where the devices are manufactured or located on the premises, to inspect the premises and medical devices on the premises to take samples of medical devices from the premises section 41FN(1) of the Act Deliver samples upon request providing samples of the medical device to the TGA upon request section 41FN(2) of the Act Availability of information access to the technical documentation that demonstrates compliance with the Essential Principles access to the evidence that appropriate conformity assessment procedures have been applied on request, provide this information to the TGA within specified timeframes section 41FN(3) of the Act Advertising material ensuring any advertising material relating to the medical device complies with the TGA requirements section 41FN(5) of the Act Report details of certain incidents and performance issues to the TGA reports events in accordance with the requirements laid out in the Therapeutic Goods Act 1989 and the Medical Device Regulations 2002 and this guidance document section 41FN(3)(d) of the Act Report any overseas regulatory actions to the TGA if the product involved is from the same an adverse event has occurred with a product in another country and the ensuing investigation by the manufacturer determines that a batch of the product should be recalled. If the batch is supplied section 41FN of the Act
audits of distribution records audits of the traceability of raw materials used in the manufacture of therapeutic goods and tracking of component parts analysis and reporting to sponsors The TGA may take corrective action in accordance with the legislation if problems are found, such as: sponsors and/or manufacturers not fulfilling their regulatory responsibilities safety concerns a medical device certifications made in the device application are incorrect or no longer correct For more information, please see Section 23. Recalls, suspensions, cancellations, and tampering of medical devices. Post-market reviews for medical devices Post-market reviews support the inclusion in the ARTG process for medical devices, which includes both random, flagged, and targeted reviews. There are three levels of post-market reviews for medical devices: Level Reason for the Review Scope Objectives of the Review Flagged (Class I) restricted word used in online eBS application GMDN Intended Purpose of the device as specified by the manufacturer Classification check accuracy and consistency of ARTG information check appropriate classification Targeted (All Classes) Targeted based on: outcomes of Flagged review recurrent breaches of advertising code repeated device test failures overseas regulatory activity/advice trends from problem reports random reviews unresolved/repeated recalls manufacturer audit reports notice from manufacturer/sponsor implant registries Flagged, Random + any or all: Manufacturer audit reports TGA laboratory testing Manufacturer audit clinical evidence Manufacturer’s Evidence technical file sterilisation validation evidence (when appropriate) matters certified in the device application check accuracy and consistency of ARTG information check appropriate classification review available documentation for potential or real of safety and performance issues certifications in device application remain correct sponsor is meeting the conditions of inclusion manufacturer shows compliance with the Essential Principles