Representation (Sponsorship)
In order to supply in Australia, a device or diagnostic must be approved by the Therapeutic Goods Administration – by means of pre-market submissions to TGA for:
- Approval of the manufacturer, and
- Inclusion of the product on the Australian Register of Therapeutic Goods
Brandwood Biomedical offers Sponsor and Agency services for all your Device Registration needs in Australia. This is more than an administrative solution - we take care of the entire regulatory process and provide complete professional management of ongoing compliance so that you can focus on building your business.
Why shouldn't I just use my distributor as my Sponsor Representative?
The selection of sponsor is critical to the orderly continuation of supply. Use of the distributor as sponsor is not recommended because:
- Distributors are focused on sales and marketing and generally don't have the regulatory skills and capacity to manage product compliance
- If a distribution contract is terminated, then the original distributor can cause disruption to continuity of supply and delay the transfer of sponsorship to the new entity. This may even force the supplier to obtain a completely new regulatory approval by means of a new application to TGA with substantial interruption to business
As a specialist market representative Brandwood Biomedical takes responsibility for the regulatory compliance and provide the interface with TGA. This provides the peace of mind of professional management of regulatory compliance, while distribution arrangements can be independently structured for maximum commercial benefit.
Contact us for more information on the services we can provide.
