PERTH, Australia – With the Brexit split now official, Australia’s Therapeutic Goods Administration (TGA) is trying to figure out the impact to its life sciences industry and the new trade relationships that will take effect after the transition period ends on Dec. 31, 2020.
U.K. notified bodies will continue to be recognized through the transition period, “so there is no immediate impact on manufacturers certified by these notified bodies,” the TGA said in recent guidance on the transitional arrangements. Sponsors of these devices can continue to provide these certificates as conformity assessment documents in Australia, and if the transition timeline is extended, the current arrangements will continue.
Although the exit agreement includes provisions for extending the transition time frame, when it looked like a no-Brexit deal scenario was likely, Australia's TGA came up with a plan to implement its own transitional arrangements to provide for minimal interruption in the supply of drugs and medical devices in Australia.
When the transition period ends, the TGA will operate on this contingency plan whereby it will continue to accept conformity assessment documents issued by U.K. notified bodies for existing products while they remain current for U.K. market authorization.
More than 90% of devices in Australia CE marked
"In Australia, more than 90% of the medical equipment is approved for supply based on European CE certificates," said Arthur Brandwood, principal of St Leonards, New South Wales-based Brandwood Biomedical.
"Australia relies heavily on imported medical technology, and most of these devices have already been assessed in Europe. Australia's TGA operates under regulations closely modeled on European rules, so for most devices, the TGA recognizes CE certification as an acceptable alternative to its own assessment," Brandwood told BioWorld.
And, a good proportion of those devices were certified by four British Notified Bodies: BSI Healthcare (U.K.), LRQA, SGS (U.K.) and UL International (U.K.), Brandwood said.
Roughly 45% of medical devices marketed in Europe were CE marked by U.K. notified bodies. For devices manufactured outside of Europe, that figure rises to 70%.
Australia amends regulations to accept conformity assessments
To allow for new applications to Australia’s Register of Therapeutic Goods with U.K. notified body certification, the TGA will amend its device regulations to recognize U.K.-certified notified bodies and to specify conformity assessment documents issued by U.K. notified bodies.
In preparing for Brexit, Australia hammered out mutual recognition agreements (MRA) with both the U.K. and the EU, and the MRA in place with the U.K. covers conformity assessment, certificates and markings.
Australian businesses will be able to continue testing and certifying that their products conform with U.K. regulatory requirements before they depart Australia, which eliminates the cost and time of duplicative testing or the need for re-certification on arrival. U.K. businesses will benefit in the same way.
The MRA with the EU recognizes certification issued in Australia and Europe, which supports device approvals in Australia as well as Australian devices to be supplied in Europe.
Some notified bodies have arranged to transfer EU certificates from U.K. notified bodies, such as BSI U.K. to the recently accredited BSI Netherlands. The TGA noted that in cases where manufacturers now have EU certificates, sponsors can apply to the TGA requesting a change of the current certificate.
The TGA stressed that sponsors must ensure that any devices they supply in Australia hold a valid conformity assessment document.
Similarly, Australian drug sponsors need to be aware that any changes made to the location of a manufacturing site registered to supply to the Australian market, requires an amended ARTG entry and associated GMP clearances.
The agency advised sponsors to submit extension applications for U.K. manufacturers that have been subject to desktop assessments and provide the updated GMP certificate as evidence via email to GMPclearance@health.gov.au