TGA: Australia Consults on Partially Harmonising with EU MDR/IVDR
The Therapeutic Goods Administration (TGA) has initiated a consultation phase to harmonise the basic principles for medical devices in Australia with the EU Medical Device Regulations. A comparison of the two regulatory systems revealed that the EU MDR and IVDR regulations impose additional safety and performance requirements, e.g. for clinical evidence or the information to be provided for medical devices. The keywords here are risk minimisation, risk management systems, and measures to reduce risks due to user error.
To implement the new requirements, the TGA proposes a 4-year transition period for existing or new applications for inclusion. A 6-year transition period is envisaged for therapeutic products already included in the Australian register. These periods are to be evaluated during the consultation phase together with the respective companies.
Not to be adopted from the EU requirements are:
- the risk minimisation of carcinogenic, mutagenic, reprotoxic, or endocrine-disrupting substances, for which there is no equivalent Australian legal framework to the EU,
- the EU Phthalates Regulation.
The TGA accepts feedback until 16 October and is hosting webinars on 11 and 12 September to provide an overview of the consultation and answer questions.
Source:
TGA: Website Overview
TGA: Consultation Paper: Proposed alignment with the European Regulations
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