An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.

1. Recall of Therapeutic Goods
Overview
Craig Davies
Director, Recalls and Case Management Section
Manufacturing Quality Branch
Medical Devices Sponsor Information Day 2017

2. Recall unit’s functions
For all therapeutic goods:
• Coordinate recall actions – a Departmental mission critical activity
• Non-Recall actions
• Product tampering issues
• Notifications from overseas regulators
• Monitoring emerging product issues
Recall of Therapeutic Goods

3. The URPTG
(current) 2004 edition
Available online at
www.tga.gov.au/industry/
recalls-urptg.htm
Recall of Therapeutic Goods

4. URPTG – Recall actions
• A recall is a market action taken to resolve a problem with a therapeutic
good for which there are deficiencies or potential deficiencies in safety,
quality, efficacy (performance) and/or presentation
• What does this mean in a medical devices context?
Recall of Therapeutic Goods

5. Current recall actions
Currently, there are three types of recall actions:
• Recall – the permanent removal of deficient goods from the market or from
use
• Recall for Product Correction – repair, modification, adjustment, re-
labelling, update to instructions for use
• Hazard Alert – providing information to health practitioners regarding
issues with implantable medical devices and advice on how to manage
recipient patients
Recall of Therapeutic Goods

6. Current non-recall actions
The URPTG also defines the following four types of non-recall actions:
• Safety Alerts – advice regarding a specific situation where the therapeutic good
meets all specifications but under a specific situation might present an
unreasonable risk of substantial harm
• Product Notification - means the issue of precautionary information about a
therapeutic good, in a situation that is unlikely to involve significant adverse health
consequences
• Withdrawal - means a sponsor's removal from supply or use of therapeutic goods
for reasons not related to their quality, safety or efficacy
• Recovery - means a sponsor's removal of therapeutic goods from sale or supply
that have not already been supplied by the sponsor
Recall of Therapeutic Goods

7. Revised URPTG
• Following extensive consultation and revision, the NEW URPTG was
published on 3 October 2017.
• It is now available on the TGA Website1 for a familiarisation period.
• The NEW URPTG will take effect on Monday, 15 January 2018.
• Important: sponsors must continue to use the CURRENT version until
15 January 2018.
1 https://www.tga.gov.au/publication/uniform-recall-procedure-therapeutic-goods-urptg-v20
Recall of Therapeutic Goods

8. Revised URPTG - changes
• Web based format - easy to navigate
• Step-by-step protocol with supporting information
• New terminologies and changed terminologies
• Roles & responsibilities of different participants
• Risk classification - inclusion of probability aspects
• Greater clarification on the requirements for medical devices
(including IVDs)
• Refined information required to assess a recall action
Recall of Therapeutic Goods

9. Revised URPTG - new terminology
• Four types of Recall Actions
are defined
– Recall
– Product Defect Correction
– Hazard Alert
– Product Defect Alert
• Four types of non-recall Actions
are defined
– Safety Alert
– Product Notification
– Quarantine
– Product Withdrawal
Recall of Therapeutic Goods

10. Recall classification - changes to current
• a situation in which there is a reasonable probability that the use
of, or exposure to, a deficient product will cause serious adverse
health consequences or death
Class I
• a situation in which use of, or exposure to, a deficient product
may cause temporary or medically reversible adverse health
consequences or where the probability of serious adverse
health consequences is remote
Class II
• a situation in which use of, or exposure to, the deficient product is
not likely to cause adverse health consequencesClass III
Recall of Therapeutic Goods

11. Who identifies the issues?
• The manufacturer through the implementation of their QMS
• Other regulators notify the TGA as part of international collaborative
activities
• TGA via its post-market monitoring and compliance activities, including
lab testing
• Inspections of manufacturing sites
• Other e.g. complaints & ‘tip offs’
Recall of Therapeutic Goods

12. Whose responsible?
• We all are
• Manufacturers
• Sponsors
• TGA
all have varying responsibilities to ensure recalls are conducted in a
timely and efficient manner which safeguards public health.
Recall of Therapeutic Goods

13. Sponsor responsibilities
• Takes primary responsibility for the recall action
• Have an established relationship with the manufacturer
• Submits the proposed communication strategy and draft recall letters for
review
• Submits the manufacturer’s risk assessment
• Maintains and provides product distribution details
• Has established recall procedures in
place
• Provides progress and close-out reports
Recall of Therapeutic Goods

14. Follow-up reporting
The recall reporting requirements are:
– 2 week and 6 week progress reports; and
– a close-out report at 3 months.
• Reports need to include:
• results of the recall
• the means of disposal, destruction or correction and confirmation that
this has occurred; and
• details of the root cause analysis and CAPA.
Recall of Therapeutic Goods

15. Legislative context
Section 41KA :Public notification and recall of
medical devices
• The Secretary’s powers and processes for
mandating device recalls not only for currently
‘included’ devices, but also for exempt,
cancelled or illegally supplied devices
• Competition and Consumer Act 2010
(consumer goods)
– notification to ACCC for safety related
actions
Recall of Therapeutic Goods

16. Questions
Recall of Therapeutic Goods