2019年 3月 13日
EMERGO BY UL SUMMARY OF KEY POINTS:
The Australian Therapeutic Goods Administration (TGA) has developed measures to minimize potential negative market impacts of the UK’s Brexit withdrawal from the European Union.
Steps TGA has put in place would take effect in the event of a no-deal Brexit, although how (and even whether) the UK actually leaves the EU remains an open question as of now; these measures are meant to prevent or minimize market and supply disruptions of medical devices in Australia.
Conformity assessments
If a no-deal Brexit comes to pass, TGA plans to continue accepting conformity assessments from UK-based Notified Bodies (NB) for devices currently listed in the Australian Register of Therapeutic Goods (ARTG) as well as for new market applications.
ARTG-listed devices may still be marketed in Australia using current CE Mark certifications issued by UK NBs and subject to UK Medicines and Healthcare Products Regulatory Agency (MHRA) oversight.
UK Notified Bodies
IF UK and EU authorities agree to an orderly Brexit, recognition of UK-based NBs will remain in place through 2020. Device certifications from these NBs will continue to be accepted by TGA for ARTG listing. For that matter, any Brexit deadline extensions agreed to by UK and EU negotiators will leave current ARTG listing arrangements in place until an actual Brexit withdrawal occurs.
Mutual Recognition Agreement between UK, Australia
In early 2019, the Australian and UK governments established a Mutual Recognition Agreement (MRA) addressing issues including recognition of certifications and conformity assessments, which will provide additional continuity measures for some types of devices in Australia.
According to Emergo by UL consultants in Sydney, TGA preparations should result in minimal short-term impact, if any, on manufacturers marketing their devices in Australia.