AudA has provided a submission to the Therapeutic Goods Administration (TGA) on its proposed refinements to the regulation of personalised medical devices. Key points in AudA’s submission include:
1. Support for TGA’s proposed principles by which personalised medical devices/products are considered for exclusion from regulation, such as ear moulds.
2. The need for an appropriate balance between making sure patient safety is maintained and ensuring health professionals are not excessively burdened by regulatory requirements.
3. The recommendation to include health professionals from the National Alliance of Self Regulating Health Professions (NASRHP) membership bodies in the list of qualified and accredited health professionals in regard to the manufacture of Class I (low risk) patient-matched medical devices.
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