Hi Alan, the timelines given by the TGA are usually a guide only - and depending on what your query was, you may not get an answer at all.

Malcolm Wootton BSc MBA We just got Emergo to do the whole thing for us. Very cost effective and only took a few weeks to get listed

Alan Farthing message me as Maetrics may be able help?

Alan - Agree with Janet - you may not get response. The relative ease and relative low cost of registration in AU could make it easier to proceed with the query via an agent. The TGA is more aligned to European Medical Device rules. As mentioned by Malcolm, using a local agency should get you a sound recommendation and also facilitate the registration. Good luck !!

Gavin Ritz Look up Val Theisz on LinkedIn she does TGA, otherwise do it yourself download the ARGMD documents and it has all the info u need. Or call them they are pretty easy to talk to.

Alan Farthing Thanks for your replies and suggestions. I have now had a response, pointing me to the relevant web pages. My problem is that I have products that seem to be differently (more sensibly!?) regulated in Australia: Denture Cleansing Tablets and alcohol Hand Gel for the general public. In the EU these are Medical Devices Class I and Biocides respectively. Not so, apparently, in Australia but what regulations do apply to these?

You will always need a local sponsor to be able to market in Australia. reg agents allow you to change your distributor easily at no cost but do have a hidden cost in themselves in they lodge all you local AEs. Ideal mix is to involve your distributor with the agent if you are doing rebate applications to supply the commercial background.

if the TGA have taken too long its probably one where a phone call is better as the answer may be a can of worms. You can also ask better Qs too.

Gavin Ritz sorry Alan, I just cant say, contact Val she will help you. As I understand it the codes are normally the same as for the EU.

Muhammad Afzal I also want to register my company with TGA, Is any one here help me?

Alan, oral hygiene products may be excluded from regulations refer to Therapeutic Goods (Excluded Goods) Order No. 1 of 2011. This will depend on the claims you want to make. With regard to the hand gel if you are not making any therapeutic claims, then the gel may be classified as a cosmetic. If you want I can look at your products an I may be able to help you.

Muhammad Afzal Hi Malcolm Wootton , how much overall cost you have given to EMERGO?

Ruth Grant Hiya, I was trained by the TGA and was the team leader of medical device regulation in NZ - The TGA are inundated with work and can take months sometimes more.... to assess applications and questions generally get referred on to consultants, they just simply cannot keep up with work! The time that I was with Medsafe the WAND notifications went from less than 20 thousand to over 40 thousand individual notifications and that would be a fraction of what should be there!!! I now work as a consultant and have had experience as an advocate for applications and products for medical device sponsors and to say the least_ communication with the authorities is much more challenging now...

Ruth Grant Hi Alan Farthing, I have sent a request to connect as I would be happy to help with your regulatory issues. Have a look at my profile and let me know If I can be of assistance to you.