Sponsor Agreement Requirements for Australia TGA

[celticfrosting]

Hello Everyone,

I have to create a sponsor agreement with our Australian distributor. The company I work for is US based and the products are CE marked. The distributor already has the ARTG certificates. From what I understand from the MDSAP Companion Guide - a sponsor agreement needs to be drafted and signed to define roles and responsibilities between parties. I was going to use our agreement for Authorized Representative in Europe as a template. I am hoping someone can help define what is required to be stated in the agreement (or a draft) as I am unfamiliar with Australian requirements? Thank you.

 

[Ronen E]

The distributor already has the ARTG certificates.

This suggests that the distributor is in breach of the Australian regulations, because having a Manufacturer-Sponsor agreement in place is a regulatory pre-requisite for the ARTG inclusion.

 

[Sicco]

Hi,
from my point of view, it is responsibility of AUS sponsor to have agreement with overseas manufacturer.
And the basic agreement should cover all of below mentioned responsibilities of sponsor which are related with manufacturer and its documentation and processes.

The Australian sponsor is responsible for:
• having procedures in place, including a written agreement with the manufacturer, to obtain information from the manufacturer when requested by the TGA
• ensuring that – they have available sufficient information to substantiate compliance with the Essential Principles or have procedures in place to ensure that such information can be obtained from the manufacturer within 20 working days – an appropriate conformity assessment procedure has been applied to the medical devices by the manufacturer – the manufacturer has appropriate conformity assessment evidence for the medical device – the conformity assessment evidence remains valid while the device is supplied in Australia
• obtaining a copy of the conformity assessment evidence from the manufacturer
• submitting the conformity assessment evidence to the TGA
• applying to include the device in the Australian Register of Therapeutic Goods (ARTG)
• meeting all the ongoing monitoring and reporting requirements applicable to sponsors once a device is included on the ARTG. For more information see Section 22. Post-market vigilance and monitoring requirements.
• providing samples of the medical device to the TGA upon request allowing a person authorised by the TGA to enter and inspect any premises, including outside Australia, where the devices are manufactured or located
• ensuring any advertising material relating to the medical device complies with the TGA requirements. For more information, see Section 12. Information about a medical device.

 

[celticfrosting]

This suggests that the distributor is in breach of the Australian regulations, because having a Manufacturer-Sponsor agreement in place is a regulatory pre-requisite for the ARTG inclusion.

I believe we have a distribution agreement in place, but all the necessary responsibilities aren't documented.

 

[celticfrosting]

Hi,
from my point of view, it is responsibility of AUS sponsor to have agreement with overseas manufacturer.
And the basic agreement should cover all of below mentioned responsibilities of sponsor which are related with manufacturer and its documentation and processes.

Thank you. This is very helpful.

 

[Ronen E]

I believe we have a distribution agreement in place, but all the necessary responsibilities aren't documented.

I wasn't referring to just any agreement, but to one that is compliant with the regulations. They are pretty prescriptive in that regard. The text Sicco posted is from the ARGMD, which is based on the regulations text.

BTW, the "current" ARGMD was issued in May 2011 and is currently under review: Australian regulatory guidelines for medical devices (ARGMD)

 

[medwise]

Thank you. This is very helpful.

In addition to the distribution agreement, manufacturer and the AU Sponsor must have a quality agreement in place to satisfy the requirements of MDSAP and the TGA for supply of medical devices in Australia. Both parties should work collaboratively to develop a quality agreement. Ultimately, the manufacturer will be responsible to demonstrate compliance with MDSAP during the audit. ARGMD based quality agreement may not be that prescriptive as long as both the post and premarket activities are covered and identifies who is responsible for what and timelines.

 

[Ronen E]

In addition to the distribution agreement, manufacturer and the AU Sponsor must have a quality agreement in place to satisfy the requirements of MDSAP and the TGA for supply of medical devices in Australia. Both parties should work collaboratively to develop a quality agreement. Ultimately, the manufacturer will be responsible to demonstrate compliance with MDSAP during the audit. ARGMD based quality agreement may not be that prescriptive as long as both the post and premarket activities are covered and identifies who is responsible for what and timelines.

2 clarifications:

1. MDSAP is not mandatory in Australia. It only applies in the Australian context if a manufacturer elects to participate in MDSAP (granted, if they want to sell in Canada they don't have much of a choice, but other than that MDSAP is voluntary) and they also sell or intend to sell in Australia.

2. ARGMD is not regulation; it's guidance (and quite an old one). So whatever is written in ARGMD is not binding but rather indicative. The binding language is the one found in the regulations as amended.