TGA Proposes 5 Medical Device Classifications in Line With EU MDR

Regulatory NewsRegulatory News | 06 March 2019 |  By 

In five separate consultations opened on Wednesday, Australia’s Therapeutic Goods Administration (TGA) proposed new medical device classifications in line with the EU medical device regulation (MDR). 

The consultations consider the current classification requirements in Australia for five specific medical device types and either propose new classification rules to be incorporated into the existing Australian medical device regulations or classification changes.

Proposals without potential amendments include medical devices that administer medicines or biologicals by inhalation, are used in direct contact with the heart, central circulatory or central nervous systems, or are substances introduced into a body via a body orifice or applied to the skin.

A consultation that proposes incorporating “a number of clarifying amendments” into current classification rules for EU MDR alignment would classify medical devices that are substances or a mixture of substances for in vitro use in direct contact with human cells, tissues and organ storage solutions and IVF media into Class III (high risk). Another consultation proposes a regulatory amendment to classify all active implantable medical devices and their accessories into Class III (high risk), as well.

The new proposals form part of the agency’s efforts around international regulatory convergence and harmonization, particularly considering the increased requirements MDR will introduce by 26 May 2020.


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