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DOC’s will need to be submitted for new Class I IVD ARTG registrations

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Author: Luis Jimenez

Similarly, to TGA’s recent notification on 1 October 2020, the TGA has issued a notice of upcoming changes for Class IVD registrations via an email to stakeholders on 17 November 2020. The notice specifies new policies for the inclusion of Class 1 IVD Medical Devices, expected to be published early December 2020.

The notice specified the following regarding new Class I IVD ARTG TGA applications:

Sponsors will be required to upload the manufacturer’s Declaration of Conformity (DoC) with new class I IVD applications.
For most applications, there will be no difference in the processing time of an application. However, some applications that may previously have been processed overnight may take up to four (4) business days to be included in the Australian Register of Therapeutic Goods (ARTG).
All Class 1 IVD medical devices in the ARTG will continue to be subject to post-market reviews in accordance with the existing process.

Expected impact to existing Class I IVD Medical Device ARTG entries

The notification did not include any changes to already existing Class I IVD Medical Devices so it is expected these will not be impacted.

Targeted Improvements

It is expected that these changes will aid TGA to make it easier for sponsors to provide the required information for TGA to make a registration decision and reduce the need for additional information requests.

What TGA’s Declaration of Conformity (DoC) entails

Templates for Declaration of Conformity are found in at the TGA’s website and they vary by classification and conformity assessment route. The DoC for Sponsors of Class I IVD Medical Devices requires the following:

Manufacturers Name
Business Address
Classification Type
GMDN Code and Term
Standards Applied to the Device
Name of Medical Device
Most importantly, they must provide a confirmation that the Manufacturer meets the Essential Principles and has the Technical Documentation to substantiate compliance.

Until now, Class I IVD registrations did not need supplemental application forms other than the ARTG application.

However, it must be noted that a DoC has always been required to be kept on file for all products marketed in Australia. When this change comes to effect, now the DoC will need to be provided by sponsors with their application documents.

Conclusion

Extrapolating from the reasoning and details of the recent change to Class I Medical Devices, the change will help the TGA confirm various factors important to determine if a manufacturer has the appropriate data and is the classification is correct for Class I Medical Device.

If you have any questions regarding these changes, please reach out, we have a team of specialised regulatory experts keeping up-to-date on the current and evolving regulatory environment for TGA and all other major regulatory bodies.