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 allowing a person authorised by the TGA to enter section 41FN(1) of the inspections of premises and inspect any premises, including outside , where Act 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 Deliver samples upon providing samples of the medical device to the TGA section 41FN(2) of the request upon request Act Availability of information access to the technical documentation that section 41FN(3) of the demonstrates compliance with the Essential Act Principles access to the evidence that appropriate conformity assessment procedures have been applied on request, provide this information to the TGA within specified timeframes Advertising material ensuring any advertising material relating to the section 41FN(5) of the medical device complies with the TGA requirements Act Report details of certain reports events in accordance with the requirements section 41FN(3)(d) of incidents and laid out in the Therapeutic Goods Act 1989 and the the Act performance issues to the Medical Device Regulations 2002 and this guidance TGA document Report any overseas an adverse event has occurred with a product in section 41FN of the Act regulatory actions to the another country and the ensuing investigation by TGA if the product the manufacturer determines that a batch of the involved is from the same product should be recalled. If the batch is supplied
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
devices-argmd-p3.docx