Session B1 Conformity Assessment

Presenters: Rebecca Gaudin (Johnson & Johnson Medical) Phoebe Smith (TGA) Ben Hanns (TGA) Gary Burgess (MTAA)

Presentation Outline

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

Introduction

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

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

Who needs TGA CA evidence?

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Manufacturers & devices that require TGA Conformity Assessment certification:

How does the TGA CA process work?

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TGA CA Process Improvements

TGA CA Process Improvements

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Volumes of CA applications received by the TGA

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Types of CA applications received by the TGA

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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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Abridged Conformity Assessment

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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Guidance

http://www.tga.gov.au/industry/devices-guidelines-reduction-assessment-fees.htm

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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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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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Combination Products

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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Guidance – Sections 14 & 15

http://www.tga.gov.au/industry/devices-argmd.htm

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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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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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CA Application Process

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Common question

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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Questions & Discussion

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