TGA Registration Services

The Therapeutic Goods Administration (TGA) provides information on therapeutic goods that can be supplied in Australia via the Australian Register of Therapeutic Goods (ARTG). To make your medical devices a legal medical supply in Australia, you must register your medical device with the TGA to be included in the ARTG.

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After obtaining registration with the TGA, your medical device can be lawfully supplied in, imported into or exported from Australia, which will provide further benefits and enhanced business performance for your company.

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Why Choose Us?

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At Wiselink, we use our expertise to help you save time and resources. We will get your medical device approved, registered and listed in the ARTG within the shortest timeframe possible. We provide full service for the complete process of your medical device registration in Australia, including:

 

• Class Identification of Medical Device

• Pre-Market Conformity Assessment

• Market Authorisation

• Post-Market Monitoring

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Your Regulatory Representative in Australia

 

By providing this service, Wiselink is responsible for the TGA registration of your medical device, and acts as the regulatory representative of your medical device in the Australian market. Under the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002, Wiselink serves as a Sponsor to liaise between your company and the TGA.

 

As your TGA Sponsor in Australia, we will use our expertise and profession to:

 

• Register your medical devices with the TGA

• Represent you as the point of contact for the TGA

• Organise and provide documentation related to your medical devices to the TGA

• Protect your confidential documents and intellectual property

• Provide regulatory consultancy to solve issues related to the TGA registration for your medical devices

• Provide our information to be used with your medical devices whenever required, such as labeling and packaging

• Provide detailed updates and reporting for your registration progress

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Looking to register your medical device with the TGA? Contact us today!

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