Session B1 - Medical Devices: Conformity assessment Presented by: Rebecca Gaudin, Regulatory Affairs Manager, JJM Gary Burgess, Director Regulatory Affairs, MTAA Ben Hanns, Medical Device Assessor, Devices Conformity Assessment Section, Office of Devices Authorisation, TGA Phoebe Smith, Senior Engineering Assessor, Devices Conformity Assessment, Office of Devices Authorisation, TGA

2. Session B1
Conformity Assessment
Presenters:
Rebecca Gaudin (Johnson & Johnson Medical)
Phoebe Smith (TGA)
Ben Hanns (TGA)
Gary Burgess (MTAA)

3. Presentation Outline
• Brief Introduction & CA Basics
• TGA Process Improvements
• Abridging Conformity Assessments
• Requirements for Devices with Medicines
• Common Issues & Helpful Hints
• Questions & Discussion

4. Introduction
• An overview of the Conformity
Assessment (CA) landscape in Australia

5. What is CA of a medical device?
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Classification determines
minimum CA procedure(s)
1 Risk based classification system
2 Conformity Assessment Procedures
3 Essential Principles
CA procedure(s) applied by manufacturer to generate
evidence that medical device complies with EPs

6. Who needs TGA CA evidence?
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Manufacturers & devices that require TGA Conformity Assessment certification:

7. How does the TGA CA process work?
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8. TGA CA Process Improvements

9. TGA CA Process Improvements
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10. Volumes of CA applications received by the TGA
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11. Types of CA applications received by the TGA
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12. Industry CA Application Improvements
“What support is available to industry in order to continuously
improve their CA applications?”
“What typical activities are undertaken by industry in order to
continuously improve their CA applications?”
TGA question to MTAA:
TGA question to Industry:
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13. Abridged Conformity
Assessment

14. Abridged CA Applications
1. Process
– Written request
– Provide supporting evidence
2. Eligibility
– Dependent on level of assessment required
– Applicants should be prepared to pay scheduled fee
3. Guidance available
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15. Guidance
http://www.tga.gov.au/industry/devices-guidelines-reduction-assessment-fees.htm
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16. Scenario that may allow an abridged
assessment:
• The manufacturer plans to implement a substantial change to the quality
management system under a Schedule 3, Part 1, 4 or 5 conformity
assessment certificate;
• The incorporation of the change in the respective conformity assessment
certificate does not require a full assessment by the TGA.
– e.g. new critical supplier
Example 1 – QMS certificates
and
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17. Scenario that may allow an abridged
assessment:
• The manufacturer submits an initial application for a Schedule 3, clause 1.6
(Design Exam) certificate;
• The kind of medical devices in the application are similar enough to a device
previously subject to full design examination by the TGA.
– e.g. identical stent to predicate device, with a different delivery system
Example 2 – Product certificates
and
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18. Combination Products

19. Combination Products
1. Compliance with additional EPs
– EP 7.4 – Verification of incorporated substance
– EP 8.2 – Control of animal, microbial or recombinant
tissues, tissue derivatives, cells and other substances
2. Guidance available
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20. Guidance –
Sections 14 & 15
http://www.tga.gov.au/industry/devices-argmd.htm
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21. Medicinal Assessment
• Verification of the safety and quality of the substance
• Verification of the ancillary action of the substance
• Varying levels of assessment depending on the
situation
Generally focused on:
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22. Human, Microbial, or Animal
• Review of manufacturer’s analysis and management of
risks around sourcing, collection, handling, viral and
transmissible agent elimination and/or inactivation of
animal materials and their derivatives – EP 8.2
• Assess validation of methods of elimination or inactivation -
EP 8.2(5)
Generally focused on:
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23. CA Application Process

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25. Common question

26. Common Questions
• Substantial change or not? (to be covered in
Session A2: Medical Devices – Changes 11:50 –
12:35 pm)
• How to submit an application
• Requirements for Kits & Procedure Packs
• MRA
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27. Questions & Discussion
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