Dec 19, 2019

The Australian Therapeutic Goods Administration (TGA) has issued an updated version of the Uniform Recall Procedure for Therapeutic Goods (URPTG). Version 2.2 does not feature substantial revisions affecting the structure of the document, but there are several points of clarification that may be necessary for sponsors (including manufacturers and distributors) to avoid mistakes associated with the recall process.

Notable changes in Version 2.2 of the Uniform Recall Procedure for Therapeutic Goods

Additions and deletions introduced in V2.2 include:

  • Recall procedure
    • Step 2, “Obtaining distribution and stock status.” V2.2 clarifies that the TGA will only directly contact affected surgeons and/or doctors in the case of an emergency. In a non-emergency recall, contacting these professionals is the responsibility of the sponsor.
    • Step 7, “Submitting recall information.” In addition to the previously listed submission method, V2.2 outlines a preferred method utilizing the TGA Business Services portal.
  • Recalls and non-recall actions
    • Under “Types of recall action,” V2.2 refines the previous statement that removal of time-expired products does not fall under the scope of a recall. It notes that this only applies to products that were released before expiring. Releasing products subsequent to expiration constitutes a process failure and therefore calls for their removal under the recall procedure.
    • In the same section, the statement that product defect correction includes updates to operating instructions is expanded. V2.2 specifies that this requirement includes procedures for service and maintenance activities that the sponsor does not directly perform.
    • V2.2 removes placeholder text referring to the unpublished document National Patient Contact Principles for patients with Implanted Medical Devices subject to Hazard Alerts and Guidance for the Development and Implementation of Procedures to achieve these Principles.
    • Under “Non-recall actions,” there is a new notice that a quarantine action may be taken on wholesale, hospital, or retail levels, but not on the consumer level.
  • Sponsor’s customer letter for recalls
    • V2.2 adds an injunction not to use the terms “voluntary” or “voluntarily” within the text of a sponsor’s customer letter, explaining that they may make it unclear to users whether they are required to perform the stated actions.
    • An alternative example of the sponsor’s customer letter is provided in a tabulated format, which is intended to make it easier to understand and execute complex recall instructions.

There are also some formatting changes that seem intended to make the document easier to navigate and scan.

The URPTG is a work in progress

The last two versions of the URPTG to be published have been focused on clarifying V2.0, the major revision to the recall procedure that was published in October 2017 and implemented in January 2018. A key feature of V2.0 was its detailed guidelines for distinguishing recall from non-recall actions. As the TGA and Australian sponsors continue to apply the revised URPTG in real-world scenarios, we may expect to see further updates that address minor oversights and ambiguities in the process.

Related resources on Australian medical device regulation:

Author

  • Timothy Herr

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