Information about the device, including copies of the: label Instructions for Use advertising material such as brochures, web pages, advertisements Information that is supplied with the device or used to promote the use of the device in . Essential Principle 13, Schedule 1 of the Regulations Section 12. Information about a medical device all information must be provided in English labelling and Instructions for Use are not necessarily required for every model or variant, unless there are significant differences in content. The copies provided must be representative include a document that lists the addresses where the device is advertised on the Internet. Risk Management Report The Essential Principles require a manufacturer to conduct a risk analysis to evaluate the known and foreseeable risks of using a device and ensuring that any undesirable side-effects are minimised and acceptable, when weighed against the benefits of the intended performance of the device Essential Principles, Schedule 1 of the Regulations Section 3. The Essential Principles The Risk Management Report required by the current accepted version of ISO14971 is acceptable. Clinical evaluation report A report that contains a comprehensive analysis of the clinical data relating to the device. The report should be objective and be prepared by an expert in the field relevant to the intended use of the device. Essential Principle 14, Schedule 1 of the Regulations Part 8, Schedule 3 of the Regulations Section 3. The Essential Principles Evidence to support the clinical competence of the author must be provided, such as a short curriculum vitae Efficacy and performance data for medical devices intended by the manufacturer to be used for disinfecting including sterilisation of another medical device (for example, instrument Data that provides evidence that the devices meet relevant efficacy and performance requirements Essential Principles, Schedule 1 of the Regulations Section 3. The Essential Principles TGO 54 Therapeutic Order No. 54—Standard for Disinfectants and Sterilants is a standard that may be used to demonstrate compliance with the relevant Essential Principles but it is not a mandatory standard Trial
where impurities and degradation products have been shown to be different information may be requested by the TGA. information may be requested by the TGA. Full pharmacology and pharmacokinetic profile Yes No No No Data to address intended action of the medicine in the context of its incorporation into the device; and in relation to its release from the device at the site of action and the subsequent distribution and elimination Yes, however if a full pharmacology and pharmacokinetic profile is conducted that allows corollary to the use in the medical device then may not be required Yes Yes Yes Clinical studies Human pharmacology including pharmacodynamics and pharmacokinetics Yes No No No Data to address intended action of the medicine in the context of its incorporation into the device; and in relation to its release from the device at the site of action and the subsequent distribution and elimination, as a minimum Not required if full human pharmacology is provided (see previous item) Yes Yes Yes Efficacy and safety studies, including adequately powered study to demonstrate performance and safety of the medical device Yes Yes—unless justification for not requiring clinical evidence is accepted Yes—unless justification for not requiring clinical evidence is accepted Yes—unless justification for not requiring clinical evidence is accepted
Section 16. Systems and procedure packs Overview ‘System or procedure pack’ is a term used in the legislation to identify products that are packaged together for a specific intended purpose. Such a package must include at least one medical device but it can also contain medicines, other therapeutic goods (OTGs), and non-therapeutic goods. A group of products packaged together that meets the definition of ‘system or procedure pack’ is considered to be a medical device for the purposes of the Act. Other groupings of therapeutic products, such as therapeutic kits and composite packs, are also discussed in this section. The term ‘system’ and the term ‘procedure pack’ are used in order to accommodate different types of packages that contain medical devices. Additionally, some manufacturers might use the term ‘procedure pack’ for a particular collection or combination of products (for example, a collection of therapeutic goods for an appendectomy surgical procedure) while other manufacturers might refer to the same collection of therapeutic goods as a system. Nevertheless, no regulatory distinction is made between the two terms. The regulatory requirements are the same regardless of whether the package of goods meets the definition of ‘system’ or meets the definition of ‘procedure pack’ or meets the definitions of both. The term ‘component’ is used to describe an individual item in a system or a procedure pack. A system or procedure pack does not consist of: An individual item only A collection of miscellaneous items that are not intended by the manufacturer to be used for a specific purpose Bulk packs of one or more items
provide the TGA with six-monthly reports detailing the supply of unapproved devices to Authorised Prescribers consider whether to submit an application to the TGA if long-term supply of device is expected monitor the use of their devices report to the TGA all those serious unanticipated device related adverse events of which they have been informed. For more information, please see Adverse event reporting requirements for clinical trials. communicate rapidly to the TGA information that has an important bearing on the benefit–risk assessment of the device, particularly any information that may lead changes to the usage of the device by Authorised Prescribers Adverse reporting requirements for Authorised Prescribers Reporter What needs to be reported Who to report to In what format? Timeframe Authorised Prescriber Any adverse device event TGA Medical Device Incident Report form As promptly as possible, to reach TGA within 15 days Sponsor As required by sponsor As required by sponsor HREC (if applicable) As required by HREC As required by HREC Sponsor Serious unanticipated adverse device related events TGA Medical Device Incident Report form fatal or life-threatening adverse device events—initial report within 7 calendar days of first knowledge. Complete report within 8 additional calendar days serious unanticipated device events, full report no later than 15 calendar days of first knowledge Other adverse device events TGA Tabulation/ Line listing On request by TGA For reports to the TGA, the report should be clearly marked 'Authorised Prescriber Incident' and sent to: The Medical Officer Clinical Section Office of Devices Authorisation Therapeutic Goods Administration PO Box 100 WODEN ACT 2606 Australia The Medical Device Incident Report form is available on the TGA website: <>.