Expect More Of The Same

Same

Over the weekend of May 18th, the Australian public went to the polls to elect the next Prime Minister. From a regulatory position, this left the Australian Regulator, The Therapeutic Goods Administration (TGA) in a position of what we call Care Taker. This position basically results in the government being unable to make any major policy decisions, any significant appointments or position changes, and not enter into major commercial transactions, such as contracts or tenders. For those within the TGA, this results in business as usual unless there is a need to make any specific regulatory decisions.

In the lead up to the election, the industry in Australia had been inundated with in excess of 20 consultations that could potentially have significant impact on the regulatory framework in Australia, including changes to classification rulings etc. The majority of these consultations stemmed from the approaching Medical Device Regulations (MDR) in the EU and an attempt to align the two systems.

With the election now behind us, we find that the Government that has been in power for the last 6 years remain. This is likely to result in the continued pace of change within the Australian Medtech industry which we’ve seen over the last few years. It may also result in the introduction of a number of these consultations that have been in circulation, which will most certainly impact manufacturers of devices, and potentially the local sponsors. One can almost guarantee a similar shift like most regulators into the Post Market scrutiny of products supplied to market. Most in Industry can see the value in this, although can also expect an increase in the need for resources, and more importantly, closer inspections by both the manufacturer and local regulatory agency.

It’s likely that with this, we’ll have more of the same pace of change from the Australian Government, and prepare for additional changes into the future.

If you’d like to talk to us about your current MDR or Australian requirements, feel free to contact us for a free no obligation discussion.


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Brandwood Biomedical offers comprehensive regulatory services in the Asia Pacific, including support to regulatory notifications and postmarket compliance “across the ditch” with our New Zealand cousins. Contact us to discuss your needs and how we can help. You can drop us an Email help@brandwoodbiomedical.com or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)

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