The Australian regulatory and reimbursement agency have particular requirements in their assessments of applications for Medical Devices intended for supply in Australia. A well-defined approach or a clearly set up manual is nonexistent but the expectations are clear, if the application has errors or a document is not conclusive than the assessment of the associated application is delayed or worse still, the complete submission may just be rejected. You may then need to start again and potentially lose your fees.

In this two-day workshop conference, you will learn the complete pathway. You will be shown what and when to submit information, particular requirements, expectations from the agencies and the determination of a forecast launch date for your products. Through case study analysis, we will examine best practices to minimize errors in order to achieve product approvals.

Learning Objectives:

Upon completing this course participants should:

  • Understand keys areas of the legislative instrument dictating regulatory requirements
  • Easily navigate pertinent website for specific documents for the application to the authorities
  • Explore the Regulatory and Reimbursement landscape, for presentation of the competitive and product comparator market to your sales and marketing team
  • Understand your accountability as an Applicant, Sponsor and Manufacturer for products supplied in Australia
  • Understand the complete submission application pathway for products with all risk classifications
  • Assess and critique documentation intended to be submitted
Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

This course is designed for people tasked with submitting applications to the Regulatory or the Reimbursement Government Authority for Medical Devices (Exclusion are IVD products).

Personnel in the following areas will benefit from the course:

  • Personnel involved in start-up or in well-established global companies with intentions to market their products in Australia
  • Regulatory professionals
  • Compliance professionals
  • Personnel involved in Research and Development
  • Marketing professionals
  • Document control specialists
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Day 1 -Lectures and Workshop Exercises
  • Module 1: Medical Devices 101 – An introduction
    • The Regulatory and the Health Economist – The Strategist or an Administrator
    • How do I confirm that my product is regulated as a Medical Device – What if decision tree
    • The assessment of the Regulatory landscape_ Who’s who in Australia -Search options
    • Responsibilities as the applicant and accountability of the sponsor and manufacturer
    • Elements of a contractual agreement between all parties -
    • Available alternative options of supply
  • Module 2: Legislative imperatives in the submission process
    • Therapeutic Goods Act
      • Significance of particular clauses
    • Therapeutic Goods Regulations
      • Significance of particular clauses
  • Let’s talk about Brexit and Regulatory implication with Europe and Australia

    The Technical file and compilation
    Key elements for inclusion – Marriage of MED/2.5.1/Rec5, GHTF STED, IMDRF/RPS WG/N9, TGA’s supporting Data form

  • Module 3
    • The intended purpose of your product and claims
    • The Australian Essential Principles Checklist
    • Comparatives to the EU Essential Requirements Checklist
      • The Australian Classification Rule
    • Comparatives to the EU Classification Rule
  • Module 4: Quality Management System 101- ISO 13485
    • Let’s talk about document management and control
      • Excel 101, power of use and the beauty of hyperlinks
    • Risk assessment 101 - ISO14971
    • When does risk assessment stop
    • Clinical product Assessment
      • Differences between Meddev 2.7/1 rev 4 and Australian proposed clinical evidence guideline
      • Comparatives of Australian guidelines to MEDDEV 2.7/1 revision 4
    • Labels and requirements
Day 02(8:30 AM - 4:30 PM)
  • Day 2 -Lectures and Workshop Exercises
  • Module 5: TGA application Process
    • Application type and Conformity Assessment approach
    • The Australian Declaration of Conformity and significance and relationship with a well set up contractual agreement.
    • The GMDN code, its significance and cost implications
    • Fees, timelines and assessment turnaround time to approval
    • Particular requirements from your manufacturer in the submission process
  • Module 6: The Australian Healthcare System and Government reimbursement of implantable products
    • Does your product qualify for reimbursement
    • The Prosthesis List Management System
    • Imperatives in the application process
    • Fees, timelines and assessment turnaround time to approval
  • Module 7: Post market accountabilities
    • Adverse Reactions – Global vs locals reporting
    • Recalls and related responsibilities
    • IRIS
    • Post market complaints reporting and the essentials of a common Standard Operating Procedure for Reporting
  • Module 8
    • Workshop and case study
    • Review of inputs into the technical file
    • Documentation management system in place
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George Azoury

George Azoury
Chief Executive Officer,RQSolutions Pty Ltd

George Azoury is principal and founder of RQSolutions. A leading consulting company located in Sydney, Australia, servicing the Medical Device Industry since 2002. Previous to this, George has held various local and regional positions in Regulatory, Compliance and Health Economics in a number of national and multinational companies. George is well known at both a local and global level with involvements with a number of companies ranging from the start-ups to the well-established manufacturing facilities in Europe, US and the Asia Pacific region.

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Local Attractions of Sydney, Australia

Sydney Opera House

Sydney Opera House

The Sydney Opera House is one of the most distinctive and famous 20th century buildings, and one of the most famous performing arts venues in the world. Though its name suggests a single venue, the project comprises multiple performance venues which together are among the busiest performing arts centers in the world — hosting over 1,500 performances each year attended by some 1.2 million people.

Sydney Harbour Bridge

Sydney Harbour Bridge

The Sydney Harbour Bridge is one of Australia's most well known and photographed landmarks. It is the world's largest (but not the longest) steel arch bridge with the top of the bridge standing 134 metres above the harbour.

Bondi Beach

Bondi Beach

Sydney's most famous beach attracts large numbers of tourists to Bondi throughout the year with many Irish and British tourists spending Christmas Day there. Bondi Beach features many popular cafes, restaurants and hotels, some with spectacular views of the beach and surrounding headlands. The beach itself is approximately one kilometer long.

Darling Harbour

Darling Harbour

A lively harbourside precinct, Darling Harbour is just a 10-minute walk from Sydney city centre. One of Sydney's largest dining, shopping and entertainment precincts has a full calendar of outdoor events as well as one of the city's most restful spots, the Chinese Gardens of Friendship.

Taronga Zoo

Taronga Zoo

Taronga Zoo is the nation's leading zoological garden, featuring Australia's finest collection of native animals and a diverse collection of exotic species. It is home to over 2,600 animals on 28.7 hectares, making it one of the largest of its kind, and it divided into eight zoogeographic regions with numerous indoor pavilions and outdoor exhibits.

The Rocks

The Rocks

The Rocks is an urban locality, tourist precinct and historic area of Sydney's city centre, in the state of New South Wales, Australia. It features a variety of souvenir and craft shops, and many themed and historic pubs. The Rocks Market operates each weekend, with around 100 stalls.

Sydney Tower

Sydney Tower

Sydney Tower is Sydney's tallest free-standing structure, and the second tallest in Australia (with the Q1 building on the Gold Coast being the tallest). The tower is open to the public, and is one of the most prominent tourist attractions in the city, being visible from a number of vantage points throughout town and from adjoining suburbs.

Museum of Contemporary Art

Museum of Contemporary Art

The Museum of Contemporary Art (abbreviated MCA) in Sydney, Australia is an Australian museum solely dedicated to exhibiting, interpreting and collecting contemporary art, both from across Australia and around the world. It is housed in the Art Deco-style former Maritime Services Board Building on the western edge of Circular Quay.

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