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Hi,
Can anyone help me with the new regulatory system for medical devices in Australia? My company is in the US and I do not know where to start with this process.
I had also heard that New Zealand may also have regulations requiring a registration process...
Started by Bridget on
, 8 posts
by 5 people.
Answer Snippets (Read the full thread at elsmar):
Http://www.tga.gov.au/
Greg ....
They can be the mother of all Bureaucracies.
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Please NOTE that "I" am the one who:
Enlarged the text that I wanted to make sure you did NOT miss.
Added the smart a_s comment in red.
The Internal Revenue Service has issued proposed regulations to provide guidance on the excise taxes imposed on the...
Started by StevenXXXX on
, 6 posts
by 5 people.
Answer Snippets (Read the full thread at cpaptalk):
The government is concerned about the medical that the medical mafia ....
Oh, yes.
Pardon me if I don't "get it", the value in taxing medical devices helping patients in any way Comments: I'm starting to use sleepyhead.
Again.
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Hi,
My company will be selling consumables for the medical devices for a company. We are not a distributor, only a sales channel. We will be ONLY selling the consumables. Are we still required to obtain ISO-13485 or a ISO-9001 would work?
Thanks
Dishant...
Started by dishant on
, 4 posts
by 4 people.
Answer Snippets (Read the full thread at elsmar):
From a legal is not required to have ISO....
We
From a USA / EC medical devices regulatory point of view - neither is formally required .
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I received a letter mid 2005 that stated if you "1. are engaged in the manufacture, preparation, or processing of a medical device (21 CFR 807.20(a)), AND" "2. introduce the device into comercial distribution, (21 CFR 807.20(c)); then you are required...
Started by Frank34 on
, 7 posts
by 7 people.
Answer Snippets (Read the full thread at elsmar):
Quote this and if so is it really saying to stop registering as a contract manufacturer of medical devices, or processing of a medical....
As a contract sterilizer of medical devices we are required to be registered with the FDA.
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Hi Every One
I faced a problem with a manufacturer , they did not want to give me their last Audit report , and we already signed a confidentiality agreement ,
This Audi report requested by SFDA for Registration
My question is
Is audit report request ...
Started by Ranileom on
, 8 posts
by 4 people.
Answer Snippets (Read the full thread at elsmar):
On of the process At SFDA is Marketing from the manufacturer the last audit report to get marketing authorization for a medical device ? Any reference for importing....
Medical device , This regulations are managed by Saudi FDA .
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TSA admits errors in searches of elderly women's medical devices TSA admits errors in searches of elderly women's medical devices
Published January 18, 2012 | Associated Press
The Transportation Security Administration says screeners at New York's Kennedy...
Started by Dennis Olson on
, 17 posts
by 13 people.
Answer Snippets (Read the full thread at timebomb2000):
They say the brace shouldn't have been X-rayed.
medical devices
The federal officials apologized.
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We are a distributor of a medical device company in the UK who has a registered Health Canada Class II device. The company will shortly be changing their sub-contract mnf. to their own mnf. plant. As a result of the manufacturing location change, they...
Started by canreg on
, 4 posts
by 3 people.
Answer Snippets (Read the full thread at elsmar):
Certificate won't be valid anymore, right? I have the same question regarding Class II devices and am.
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Thanks Penelope Blue!
http://radiographics.rsnajnls.org/cgi/content/abstract/24/6/1725
DOI: 10.1148/rg.246045031
Chest Radiology
RadioGraphics 2004;24:1725-1746
© RSNA, 2004
SPECIAL REPORT
Medical Devices of the Chest1
Tim B. Hunter, MD, Mihra S. Taljanovic...
Started by SPONSORED on
, 4 posts
by 1 people.
Answer Snippets (Read the full thread at mombu):
Tsau, MD, William
G is no longer
considered....
Taljanovic, MD, Pei H.
Hunter, MD, Mihra S.
Is no longer
considered unusual, and in many large medical centers, ventricular
assist devices and total
Medical Devices of the Chest1
Tim B.
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Because HAs are classified as medical devices, users have limited access to normal market support. Instead of Consumer Reports, we have our own specially trained (and financially motivated) professional to explain things. Instead of commonly agreed upon...
Started by David9683 on
, 4 posts
by 2 people.
Answer Snippets (Read the full thread at hearingaidforums):
Just like are considered....
Hearing aids are classified as medical devices, because they are medical devices.
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Last month France was in the news due to breast implants gone bad. The company that manufactured the implants had gone out of business, so the French government was going to pay for all of the women who got the implants to have them removed/replaced ....
Started by Olivia_WebMD_Staff on
, 8 posts
by 6 people.
Answer Snippets (Read the full thread at webmd):
With the current set-up in the....
It's a form of preventative care.
Once the company that manufactured faulty devices went to remove the devices before additional problems manifest.
It is in effect the insurance provider), the US does not .
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