Also the the country to which the implants are to be imported they always prefer to have the GHTF certification.
The Global Harmonization Task Force was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems. This is being done with two aims in mind: enhancing patient safety and increasing access to safe, effective and clinically beneficial medical technologies around the world.
A partnership between regulatory authorities and regulated industry, the GHTF is comprised of five Founding Members: European Union, United States, Canada, Australia and Japan. The chairmanship is rotated among the Founding Members and presently resides with Japan.
https://docs.google.com/viewer?a=v&pid=explorer&chrome=true&srcid=0B0IPdn9hAwuLYTY0MmJmMzctNDAwZi00NGZhLThjN2MtOWJjZTE1MGFhZWU3&hl=en_GB
https://docs.google.com/viewer?a=v&pid=explorer&chrome=true&srcid=0B0IPdn9hAwuLNmJmNjZiOTAtZWFiMy00MzkxLThkYjgtMDJiZGI1ZGVlNDIz&hl=en_GB
https://docs.google.com/viewer?a=v&pid=explorer&chrome=true&srcid=0B0IPdn9hAwuLNjNkZTZhZjMtZjUwNS00NmZlLThjOTEtNDJmODJlNTRlMDI0&hl=en_GB
https://docs.google.com/viewer?a=v&pid=explorer&chrome=true&srcid=0B0IPdn9hAwuLMWQxNWM3MTItMDViMi00M2EzLWJkMmUtOGZlYzZiYjJhYzJm&hl=en_GB
https://docs.google.com/viewer?a=v&pid=explorer&chrome=true&srcid=0B0IPdn9hAwuLNTZhNzUxNDYtODRjMy00ODU0LTljZDItYTRkMDg1MmUwZDYz&hl=en_GB
These are the free documents available on the GHTF Website but I am sharing the same as required to underwent several searches for the same.
Please Post any questions if you required any guidance!!
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