Easier path to approval for medical device manufacturers

The federal government plans to introduce new regulations to allow local manufacturers of medical devices to obtain market approval in Australia if they have been certified by a recognised European conformity body.

At present, medical devices must receive market approval from the Therapeutic Goods Administration (TGA) even if they have passed Europe's CE Mark approval process.

Regulatory amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 will be introduced later this year to cover applications for lower risk Class II and Class III medical devices and in vitro diagnostics (IVDs) such as hearing aids, joint implants and devices used for in vitro fertilisation procedures.

Assistant Health Minister Fiona Nash said the new rules will not apply to the very highest risk devices, such as those devices containing medicines or tissues of animal, biological or microbial origin, or Class 4 IVDs such as drug-eluting stents or tests for HIV.

“These devices will still need TGA conformity assessment,” Senator Nash said. “With these changes, Australian manufacturers can choose to either have conformity assessment conducted by the TGA or an alternative conformity assessment body, such as a European notified body.”

She said the new arrangements would bring Australian manufacturers in line with the regulations for overseas manufacturers, and in some cases would enable devices to get to market more quickly.

Posted in Australian eHealth

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