Periodic surveillance audits will be performed by the TGA or EU Notified Body Part 5, Product quality Manufacturer must implement a quality Class I Assessment can cover a wide range of devices—not limited to a management system management system (that is, ISO (measuring), specific device. excluding clauses 7.3 and 7.5.2) and A system encompassing IIa, For Class I (measuring) and Class IIa devices this only covers arrange for the quality management the inspection and production—the design of each device still requires Part 6 system to be audited by the TGA or a EU Class IIb testing of a medical device conformity assessment. Notified Body. Please note: can For Class IIb devices this only covers production—the design of The TGA or EU Notified Body also reviews not be used for each device still requires conformity assessment under Part 2. a sample of the manufacturer’s technical sterile devices documentation for the devices. May be resource intensive to initially establish appropriate procedures. The quality management system must be maintained Periodic surveillance audits will be performed by the TGA or EU Notified Body Part 6, Declaration of Manufacturer ensures that the device(s) Class I, For Class I non-measuring and non-sterile devices the evidence Conformity (not requiring comply with the Essential Principles and (Declaration of Conformity) is not required to be submitted to the Class I assessment by Secretary) prepares documentation that TGA but MUST be available upon request. (measuring demonstrates conformity. Preparing technical and/or sterile), For Class I (measuring and sterile) and Class IIa devices, documentation for a Class IIa conformity assessment under Part 3, Part 4 (sterile devices) or medical device and Part 5 is also required. establish a post-market monitoring system Part 7, Conformity Applies to custom-made medical devices, All For custom-made medical devices, see Section 18. Custom-made Assessment Procedures for systems and procedure packs medical devices. Please note: devices used for a Special sterile systems For systems and procedure packs, see Section 16. Systems and Purpose and procedure procedures packs. also require Part 4 certification
Periodic surveillance audits will be performed by the TGA or EU Notified Body Part 5, Product quality management system A system encompassing the inspection and testing of a medical device Manufacturer must implement a quality management system (that is, ISO excluding clauses 7.3 and 7.5.2) and arrange for the quality management system to be audited by the TGA or a EU Notified Body. The TGA or EU Notified Body also reviews a sample of the manufacturer’s technical documentation for the devices. Class I (measuring), IIa, Class IIb Please note: can not be used for sterile devices Assessment can cover a wide range of devices—not limited to a specific device. For Class I (measuring) and Class IIa devices this only covers production—the design of each device still requires Part 6 conformity assessment. For Class IIb devices this only covers production—the design of each device still requires conformity assessment under Part 2. May be resource intensive to initially establish appropriate procedures. The quality management system must be maintained Periodic surveillance audits will be performed by the TGA or EU Notified Body Part 6, Declaration of Conformity (not requiring assessment by Secretary) Preparing technical documentation for a medical device and establish a post-market monitoring system Manufacturer ensures that the device(s) comply with the Essential Principles and prepares documentation that demonstrates conformity. Class I, Class I (measuring and/or sterile), Class IIa For Class I non-measuring and non-sterile devices the evidence (Declaration of Conformity) is not required to be submitted to the TGA but MUST be available upon request. For Class I (measuring and sterile) and Class IIa devices, conformity assessment under Part 3, Part 4 (sterile devices) or Part 5 is also required. Part 7, Conformity Assessment Procedures for devices used for a Special Purpose Applies to custom-made medical devices, systems and procedure packs All Please note: sterile systems and procedure also require Part 4 certification For custom-made medical devices, see Section 18. Custom-made medical devices. For systems and procedure packs, see Section 16. Systems and procedures packs.
devices-argmd-p1-01.docx