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Medical device annual reporting - Sponsor obligations

15 May 2019

All sponsors of medical devices included on the Australian Register of Therapeutic Goods (ARTG) must comply with certain automatic conditions of inclusion.

For sponsors of Class IIb (implantable) and Class III devices, AIMD or Class 4 IVD, these obligations include submitting annual reports to the TGA for the first three years of inclusion in the ARTG. Annual reports are due on October 1 of each year.

In previous years as a matter of courtesy, the TGA has issued a formal correspondence requesting the information under s41JA of the Act. This practice will not be continued. This was disseminated to industry representatives as Item 2.2 of the RegTech Forum on 28 February 2019. No objections were raised at the meeting in regard to this change of practice.

Failure to provide the information by the due date will result in regulatory action.

More information on annual reporting requirements can be found in section 22 of the Australian Regulatory Guidance for Medical Devices (ARGMD).

Any questions regarding annual reporting, can be sent to: postmarketdevices@health.gov.au