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industry associated links to international regulations

The links provided below may be of some assistance if you are looking to register your product in different countries.

Location Organisation Website Address  
Australia Australia TGA www.tga.gov.au
New Zealand New Zealand MEDSAFE www.medsafe.govt.nz
Europe Europe MDD 90/385/EEC http://eur-lex.europa.eu/en/index.htm
Europe Europe MDD 93/42/EEC http://eur-lex.europa.eu/en/index.htm
GHTF GHTF www.ghtf.org
United Kingdom UK MHRA www.mhra.gov.uk/Howweregulate/index.htm
US FDA US FDA www.fda.gov
China SFDA China SFDA eng.sfda.gov.cn/eng
Singapore HSA Singapore HSA www.hsa.gov.sg

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Quality and Regulatory Officer at Ausonex Pty Ltd
"Anne helped guide Ausonex through the ISO 13485 documentation, FDA regulations and risk analyses. Anne is highly experienced in the manufacturing and wet sciences area, and was capable of readily applying her knowledge and experience to the areas of hardware and software design for medical devices."
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Acrapack is proud to be a member of the following associations
 
AusBiotech - Australia's Biotechnology Organisation IVD Australia Science Industry Australia Association of Therapeutic Goods Consultants
 
   
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