"Registered Device " and "Listed Device" in TGA Registration for Medical Devices

G

gxzn008

#1
how to understand the "registered device " and "listed device" in TGA registration for medical device.

Thanks.
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
how to understand the "registered device " and "listed device" in TGA registration for medical device.

Thanks.
Hi,

As far as I understand, these relate to older legislation (prior to 2002). Today medical devices are "included" on the ARTG, while listing and registration are related to other therapeutic goods (or historical entries).

I found an oldish guidance document from the TGA (2005) which states:

Registrable, listable or included goods

The Act, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 provide that the ARTG has 3 parts, one relating to registrable goods, one relating to listable goods and the other relating to included medical devices.

Registrable and listable goods, including therapeutic devices, are regulated under Chapter 3 of the Act. Registrable goods undergo a more rigorous evaluation of their quality, safety and efficacy, before being entered into the ARTG, than listable therapeutic devices.

Medical devices are regulated under Chapter 4 of the Act and can be included in the ARTG if they comply with the essential principles, have undergone an appropriate conformity assessment procedure and certain other requirements are complied with.
I hope you'll find it helpful.

Cheers,
Ronen.
 
B

Bassman84

#4
Hi, I hope that someone can provide some info.

How do I register a change in Legal Manufacturer.

Also how do I register a new Manufacturing Facility.

In both cases, with the TGA!
Thanks!!:read:
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Hi, I hope that someone can provide some info.

How do I register a change in Legal Manufacturer.

Also how do I register a new Manufacturing Facility.

In both cases, with the TGA!
Thanks!!:read:
What sort of product(s)?
Is it already on the ARTG?
Where are the facilities - inside Australia or outside?

Cheers,
Ronen.
 
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