Australia TGA Medical Device Sponsor Agreement - Example or Template

#4
Hello,
as I wrote in another thread

The basic agreement should cover all of below mentioned responsibilities of sponsor (excerpt from old ARGMD) 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.
 


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