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RANZCO comments on ophthalmic device regulatory reforms

08/05/2019By Myles Hume
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RANZCO has lodged submissions in response to two separate proposals by the Therapeutic Goods Administration (TGA), as the government body seeks to reform and align medical device regulations with the European Union (EU).

As part of a major program to strengthen regulation of medicines and medical devices in Australia, the TGA has drafted new classification proposals for active implantable medical devices (AIMS), and substances introduced into the body via an orifice or applied to the skin.

Both consultation papers have been spurred by a government recommendation in September 2016 to bring medical device regulations in line with the EU. The move is expected to enhance safety and improve Australia’s access to the global medical device market.

In addressing the first draft reform, RANZCO endorsed the regulator’s recommendation to change the classification of AIMS, which would see them fall under Class III – the most stringent classification.

Currently, AIMS currently fall under their own standalone category – Class AIMS – and are subject to the same level of regulatory scrutiny as Class III.

"The proposed reclassification will improve clarity and consistency in the terminology and facilitate a better functioning of the medical devices market while also achieving timely access and high standards of quality, safety and performance"
Therapeutic Goods Administration

The TGA states that the new classification would “harmonise” the Australian medical device regulations with the EU, and more broadly internationally. All AIMS accessories would also fall into Class III under the proposals.

“The proposed reclassification will improve clarity and consistency in the terminology and facilitate a better functioning of the medical devices market while also achieving timely access and high standards of quality, safety and performance,” the TGA proposal stated.

In its second submission regarding substances introduced into the body, RANZCO opposed the TGA’s plan to reclassify proprietary eye irrigation solutions from Class I – Sterile (low to medium risk) to Class IIb (medium to high risk), which would increase the minimum requirement to obtain approval.

The TGA claims the eye drops may be used to flush the eye of particulates or chemicals, and were “absorbed” into the body.

RANZCO disagreed, stating:” [The college] believes they should remain as Class I - Sterile since they are not intended for absorption into the body, the particular feature that would require reclassification.” Both documents were released for public consultation in March, which ended 29 April.

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