Medical device reforms: a huge win for industry

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The peak business organisation representing manufacturers and suppliers of dental products, the Australian Dental Industry Association (ADIA), has welcomed and strongly endorsed the Australian government’s response to the review of medicines and medical device regulation.

“ADIA has been a vocal proponent for reforms to ensure that the medical device regulatory framework is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden. The reform pathway offered by the Minister for Health helps achieve this,” said ADIA chief executive officer Troy Williams.

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As a result of advocacy undertaken by ADIA and other stakeholders in the medical device sector, the government has accepted the need to alter regulatory approval processes that will allow for faster access to certain medical devices that are approved based on assessments from comparable overseas regulators.

Consistent with ADIA’s advice to the government, the proposed reforms will reduce duplication of effort leading to a more efficient process, while ensuring Australian consumer protection is maintained through retention of oversight by the Therapeutic Goods Administration (TGA) as the final decision-making authority.

“From the perspective of the dental industry, increased reliance on assessment from comparable overseas regulators is a game changer. It will significantly reduce red tape for manufactures and suppliers of dental products and allow them to introduce new and innovative products to the Australian market faster and with lower costs than before,” said Williams.

The proposed reforms will not alter the need for most medical devices to be placed on the Australian Register of Therapeutic Goods (ARTG) with the obligations of manufacturers and importers in this regard remaining largely unchanged. The major outcome of the reforms is that the process of confirming products meet the relevant standards will be considerably easier in the future.

“Particularly for importers of dental products, if the relevant Conformity Assessment has been undertaken by a body acceptable to the TGA, the costs will be lower and the timeframe shorter. It’s a huge win for the industry,” said Williams.

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