Acrapack Regulatory Consultants

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
Australia ARCS Australia www.arcs.com.au/
Australia The Medical Technology Association of Australia www.mtaa.org.au/
Australia Science Industry Australia http://scienceindustry.com.au/
Australia IVD Australia http://www.ivd.org.au/
Australia AusBiotech http://www.ausbiotech.org/
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
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

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.

Contact Acrapack

Regulatory Affairs and ISO 13485 expert

“Anne is prompt and efficient in all aspects of the work that she carries out for our medical company in regards to our regulatory requirements with the TGA. She demonstrates an in depth knowledge of the processes and requirements. We look forward to continuing our solid relationship.”
August 20, 2014

Top qualities: Expert, Good Value, On Time
Robert Yee

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ACRA regulatory services as your Australian sponsor

Acting on your behalf as to register your medical device by communicating with the Therapeutic Goods Administration (TGA) and carrying out obligations placed on the Australian sponsor in relation to medical device or IVD device registrations, in order to meet and show compliance with the Australian Therapeutic Goods requirements.

Find out more about how we can assist as your Australian sponsor

Acrapack is proud to be a member of the following associations

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Let Anne and Acrapack assist you with your regulatory and quality challenges, or with your quality management system development.

> Find out how Acrapack can help you

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