Guidance documents available for various device manufacturing concerns
The TGA published guidance documents on the following subjects:
- Manufacturers' obligations for manufacturing medical devices and their component parts, including by 3D printing, in response to the COVID-19 emergency: Notably, the TGA advises companies interested in manufacturing devices or parts to register their interest and core competencies on the Advanced Manufacturing Growth Centre (AMGC)'s COVID-19 response page. Custom Made devices (such as those that are 3D printed for a specific patient based on a diagnostic image) do not need to be included in the ARTG.
- Personal protective equipment (PPE) (e.g., face masks, gowns, and gloves): PPE with claims for therapeutic use (e.g., surgical and examination masks intended to reduce or prevent the transmission of disease or micro-organisms), or intended for use in a clinical setting, are regulated as medical devices in Australia and must be included in the ARTG. However, non-sterile protective or safety apparel/equipment for use at home, or for occupational use, are declared to not be therapeutic goods under the Therapeutic Goods (Declared Goods) Order 2019. Several examples of masks and other PPE products are provided, with commentary on the applicable regulatory categorization in Australia.
- Re-processing single-use products: The TGA notes that many single-use products are not appropriate for re-use, and there are risks associated with re-processing that should be considered. Also, companies that re-process single-use medical devices will be considered manufacturers and must therefore apply appropriate conformity assessment procedures and inclusion in the ARTG. Additionally, the TGA, together with the Office of Health Protection (OHP), released a page titled "Advice on surgical masks and gowns during COVID-19," with additional details on these products.
- Additional equipment for treatment of COVID-19 in the event ventilators become insufficient: The guidance provides information regarding alternatives to purpose-made ICU ventilators, in addition to the guidance page titled "Information for Clinicians on Ventilators and Alternative Strategies When in Short Supply," which has also been updated to include all recent developments and additional advice on ventilators and their alternatives.
- Thermometers: The guidance includes advice on classification, conformity assessment, and the ARTG application process, and re-emphasizes that the TGA is currently prioritizing all COVID-19-related reviews. Sponsors do not need to contact the TGA to request an expedited review; the TGA will automatically process these applications as an urgent priority.
- Labeling obligations: The legal manufacturer's name and address must appear on the device's label, Instructions for Use (IFU), and other information provided with the device. The Sponsor's name and address must also be provided on the device itself, or if not practicable, then on the packaging label or IFU, so that the user can readily identify the Sponsor. The guidance further outlines the required information in the label as per Essential Principle 13.3. All information must be provided in English.
Other TGA announcements relating to COVID-19
In addition to the numerous documents and information pages alluded to above, the TGA released other announcements regarding its operations and the regulation of medical devices intended to combat the COVID-19 pandemic:
- Overseas inspections and audits suspended: Due to the travel restrictions put in place in response to the ongoing COVID-19 pandemic, the TGA has announced the suspension of all overseas GMP inspections and QMS audits until further notice. The TGA stated that there is no impact to domestic QMS audits, at present, but they will provide further updates if the status changes.
- Warning regarding advertising: In February, the TGA issued a warning to industry reminding companies that "claims such as preventing the spread of coronavirus (for example, through the use of face masks or disinfectants)... are considered to be therapeutic use claims." Furthermore, “promotion of therapeutic goods to consumers for the prevention or treatment of novel coronavirus is likely to contravene the legislative requirements for a range of reasons, including unsupported claims or making a restricted representation,” and "advertising must not be inconsistent with any current public health campaigns.” COVID-19 IVDs are not exempt from the Australian advertising framework, and advertisements cannot be directed to consumers.
- COVID-19 testing in Australia: The TGA published information related to IVD testing for COVID-19 in the country. Notably, the TGA has decided to impose additional conditions on the supply of approved serology tests intended for use at the point-of-care. These tests may only be supplied to certain customers specified by the TGA (including accredited pathology laboratories and legally registered medical practitioners, among others). The TGA has also published a list of COVID-19 test kits currently included on the ARTG, with details such as the location of use and type of test.
- Additional information on point-of-care serology tests: The TGA subsequently published further information on point-of-care serology IVD testing for COVID-19, noting that there is significant variation in how these tests are being used across Australia. While Western Australia and South Australia have introduced certain prohibitions on the supply of point-of-care tests, other areas are permitting their use under certain conditions. Because the currently available point-of-care serology tests only detect IgM and/or IgG antibodies, they can neither determine if a person is infectious, nor detect if a person has been infected recently (within the last week or so). The TGA advises that there is significant risk relating to misinterpretation of results, for instance due to the possibility of false positives and false negatives. The TGA provides a number of recommendations for offering point-of-care testing for COVID-19.
Related resources on Australian medical device regulation:
- Australia emergency use pathways for medical devices
- Australian TGA medical device registration consulting
- Australian TGA Sponsor in-country representation
- Process chart: Australian TGA regulatory approval process
- Whitepaper: Medical device registration in Australia and New Zealand