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 | |
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Australia TGA | www.tga.gov.au | ![]() |
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ARCS Australia | www.arcs.com.au/ | ![]() |
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The Medical Technology Association of Australia | www.mtaa.org.au/ | ![]() |
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Science Industry Australia | http://scienceindustry.com.au/ | ![]() |
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IVD Australia | http://www.ivd.org.au/ | ![]() |
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AusBiotech | http://www.ausbiotech.org/ | ![]() |
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New Zealand MEDSAFE |
www.medsafe.govt.nz | ![]() |
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Europe MDD 90/385/EEC | http://eur-lex.europa.eu/en/index.htm | ![]() |
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Europe MDD 93/42/EEC | http://eur-lex.europa.eu/en/index.htm | ![]() |
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UK MHRA | www.mhra.gov.uk/Howweregulate/index.htm | ![]() |
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US FDA | www.fda.gov | ![]() |
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China SFDA | eng.sfda.gov.cn/eng | ![]() |
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Singapore HSA | www.hsa.gov.sg | ![]() |
How to contact us
If you have any further questions or inquiries about your private information, please feel free to email or call us on +61 400 284 808 (0400 284 808 within Australia) with your query.
Contact us to start the process and register your medical device.