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 restricted word used in GMDN check accuracy and online eBS application consistency of ARTG (Class I) Intended Purpose of the information device as specified by the manufacturer check appropriate classification Classification Targeted Targeted based on: Flagged, Random + any or check accuracy and (All all: consistency of ARTG outcomes of Flagged Classes) information review Manufacturer audit reports check appropriate recurrent breaches of classification advertising code TGA laboratory testing review available repeated device test Manufacturer audit documentation for potential or failures real of safety and clinical evidence performance issues overseas regulatory Manufacturer’s activity/advice certifications in device Evidence application remain correct trends from problem technical file reports sponsor is meeting the sterilisation validation conditions of inclusion random reviews evidence (when manufacturer shows unresolved/repeated appropriate) compliance with the Essential recalls matters certified in the Principles manufacturer audit device application reports notice from manufacturer/sponsor implant registries
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
devices-argmd-p3.docx