The medical device manufacturer based outside Australia who intend to launch their medical devices in Australia shall appoint an Australian TGA sponsor. The Australian Sponsor acts as liaison between the Therapeutic Goods Administration (TGA) and the foreign manufacturer. This is mandated as per the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990 and Therapeutic Goods (medical devices) Regulations 2002. The Australian Sponsor is also termed as Australian Authorized Representative or TGA Sponsor.
Who can act as an Australian TGA Sponsor?
The Australian sponsor must be a citizen and resident of Australia. In case of an organization acting as a sponsor, it must be an incorporated body in Australia and should be carrying out business in Australia. The employee or representative of such organization shall be residing within Australia. Manufacturers may appoint a distributor as their Australian TGA Sponsor. However, appointing an independent third party as an Australian TGA Sponsor gives more control over the registration and provides more flexibility in changing distributors or appointing multiple distributors for better market penetration.
What is the role of an Australian TGA Sponsor?
An Australian TGA sponsor plays a vital role in device registration process and post market compliance. Before commercialization of the products, the sponsor will register the goods with the TGA and also assist to encounter the audits. The Sponsor maintains the track on Regulatory updates, to help the manufacturing companies meet the updated Regulatory requirements, by maintaining the technical documents recommended by the Agency. The Sponsor shall also maintain the distributor records from the manufacturer.
What are the Regulatory Obligations of an Australian TGA Sponsor?
The legislation requires the Sponsor of an Australian medical device to comply with the certain requirements. The Australian TGA sponsor responsibilities include -
- Allow entry of the TGA official into the premises for inspecting the premises
- Deliver samples upon request by the TGA official
- Availability of device related information such as, technical file, GSPR etc.
- Advertising material
- Sponsor shall report the details of certain incidents and performance issues to the TGA
- Report any overseas Regulatory actions to the TGA, if the product involved is from the same batch or production run that was supplied in Australia
- Sponsor shall report to the TGA, the results of investigations undertaken by the manufacturer
- Assist the TGA and the manufacturer in investigations, if an incident occurs
- Take corrective action, when required
- Maintain distribution records for product supplied in or exported from Australia
- Conditions imposed, when medical devices are included in the ARTG
Would you like to gain more inputs on Australia TGA Sponsor? Or are you looking for a Sponsor to support you in Australian market-entry? Gain inputs. Reach out to Freyr.