Hey Guys,
I am trying to start my business in medical devices in Australia. The devices I want to sell would be transplanted inside the body of human being like pacemakers etc.
Would anyone know how to gets these devices completely certified?
I am pursing this business in this for the first time and not sure how to get my products certified.
Any other people with this experience if they can share their experience, it will be very very very helpful.
are you selling eyePhones?
I doubt it there is only one global distributor of them, Mom's Friendly Robot Company.
Is this what this site has come to? You have a business idea in one of the most government regulated fields on the planet. As you don't know what you're doing you decide to post questions in bargain forums. If you have to ask…..
Butt if its cheap, I might buy a dozen and put them inside me :\
Maybe they should post it as a deal?
If you have to ask OzBargain, I think you better start off by asking about scalpels and retractors. For them to be used in OR, there's already a whole lot of certifications.
To bring in mechanical prosthetics, there's another layer of certifications.
For implanted prosthetics, yet another layer.
For implanted eletronics, yet another.
For implanted electronics that are vital, yet another.
It will likely involve you having to pay independant lab(s) to perform bench tests followed by controlled clinical trials with longitudinal studies. If you're bringing in something that already has a competitor, you better come armed with a yacht to carry your money.
Oh, don't forget your second yacth to bring the specialist out for a cruise to introduce your new product line, a few import specialist to talk about your products and a few demonstration cases.
Mi-Heart by Xiaomi
Hold the qi wireless charging pad to chest
when the ticker starts going slow
As far as I know TGA does approvals, no idea if useful info, but imo I'd probably be a supplier/tester/debugger/distributor of a more major company. As someone who used to be a biomed (just maintenance and repair though) its one of the few areas you don't typically "cheap out on" a lot of other companies may pick "price first" then functions. In hospital though you pick best possible product first, price comes way down the list. If you are basically a no name, you will definitely be a no buy because if your device fails and it gets to court, there's no way I'd be able to argue that I wanted to cheap out, no matter how good my bargain skillz are (not very).
Also if you're a supplier of a major distributor they likely already have certifications with TGA, IMO never tried it but always been told getting TGA approval is really really hard.
Also might have to look out any other regulations and things you might need to have, for example most of the time its expected that a medical device is tested (everyone we had came pretested) are you willing to figure out how to test it all, do you have the qualifications to approve a tested medical device? Do you know how to test it?
It's an extensive process to get the devices certified.
What are we talking in terms of product history? A product that is not on the market elsewhere? A new type of device? There are too many variables in your question without specifics is what I am probably getting at.
If you are just planning on sponsoring a device into the country and you are dealing with a reputable manufacturer with a history of compliance, it's not that complicated.
https://www.tga.gov.au/publication/australian-regulatory-gui…
^^ Has all the information you need to put you off the idea, plain and simple.
My advice would be to start importing something else first, learn the processes involved with product importation and the liabilities and insurances required (on quite elemental products). Once you have that under your belt evolve up the food chain to more complex electrical devices which require local certification - then move forward into more specialised high risk products.
Make sure you have good business insurance and plenty of it. If your gadgets incinerate or electricate someone they will come after you. I (very) limited liability company may be a good investment.
First step is to get an endorsement from Dr Nick
Maybe start an ebay store reselling mobile phone cases or something.
It is obvious you have absolutely no idea what you are doing.
I once said I worked in the medical industry on OzB and the amount of messages I get. Doctors with their crazy ideas, people wanting to know which company I work for and people wanting me to help them start a business. Yeah nah.
Post history indicates OP once missed out on an $11 Burrito credit…
I'd say you need around 10-50 million burritos of money before you even start this project…
I’d assume you’d need a lot of $$, I wouldn’t even look at it if you didn’t..