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Med QMS

Medical Devices QMS and Regulatory Affairs Melbourne

For all your Medical Device Quality Assurance and Regulatory Affairs needs

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TGA Sponsor Representation

Australian TGA Sponsor Representation for Medical Device Companies

An overseas manufacturer wishing to import and sell a medical device in Australia must register the device on the ARTG before selling in Australia.
A business that wants to sell in Australia but does not reside in Australia would need an in-country representation – TGA Sponsor (similar to Authorised Representative requirements in EU).
The main roles of a TGA Sponsor are to communicate with TGA, register the medical device on ARTG and act as a regulatory representative before and during commercialisation in Australia.
TGA requires Sponsor contact details to be stated on the package label and IFU.

How can we help:

We can act as your Australian Sponsor (TGA Sponsor) as required by Australian Therapeutic Goods (Medical Device) Regulations 2002.
As part of the Australian Sponsor services we provide the following:

  • Device registration on the ARTG (Australian Register of Therapeutic Goods).
  • Storing your technical file to make it available for TGA review upon request.
  • Review of advertising materials, labels, and IFU before use.
  • Represent the company in Australia as required by TGA, including adding MED QMS contact details on the device labels and IFUs.
  • Assisting in reporting adverse events and recalls to TGA

Please contact us for further details.

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Med QMS

For all your Quality Assurance and Regulatory Affairs requirements.

+61 410 717 106

alexander@medicalqms.com.au

Melbourne based

Elsternwick VIC 3185
Australia

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Our Services

  • All Services
  • QMS Services and Audits
  • Regulatory Affairs
  • QMS Setup
  • Regulatory and QMS Training
  • TGA Sponsor Representation
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About

With 20 years’ experience in the medical device industry, both managing Quality, and Regulatory Affairs and as an active auditor, we can be counted on to deliver the systems, documentation and advice required.
We pride ourselves on having achieved 100% compliance for all our clients. Continue reading …

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