The TGA, Australia has updated its guidance on the Declaration of Conformity (DoC) procedures for certain Class I medical devices.
The guidance was originally published in December 2020. It has now been updated to Version 1.1 to include Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only).
To which Class I devices is the guidance applicable?
The guidance applies to the DoC procedures for:
- Class I non-sterile, non-measuring medical devices
- Class 1 in vitro diagnostic (IVD) devices
- Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only)
- Class I Systems and Procedure Packs
Who is the guidance for?
The document is designed to assist:
- manufacturers in completing the relevant DoC
- sponsors confirming that documentation prepared by the manufacturer is complete.
About the Declaration of Conformity (DoC)
The Declaration of Conformity: provides sponsors and the TGA with information about a medical device to ensure compliance with the following as per Australian legislation:
- the Essential Principles
- the classification rules and the
- appropriate conformity procedures
Manufacturer and sponsor responsibilities concerning the DoC
A person or entity may be both, sponsor and manufacturer if they satisfy the relevant legal requirements and are aware of their ongoing responsibilities.
Manufacturers and sponsors have different responsibilities.
The manufacturer must complete and sign a DoC, maintain and update it.
The sponsor will require a copy of the completed DoC from the manufacturer to complete the application for inclusion in the ARTG for Class I non-sterile non-measuring medical devices and Class I IVD medical devices, and Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only).
Source: TGA Website