TGA changes for Medical Devices in Australia
•
7 likes•2,597 views
http://MedicalDevicesGroup.net Sydney-based regulatory affairs expert Arthur Brandwood discusses the recent changes made by the Australian Therapeutic Goods Administration (TGA). He also covers: • Australia’s aggressive deregulatory agenda • The Australian tax incentive (43.5% for R&D expenditure) • The simple process for regulation of clinical trials in Australia • TGA’s web based submission process for device approvals
Recommended
Recommended
More Related Content
What's hot
What's hot (20)
Similar to TGA changes for Medical Devices in Australia
Similar to TGA changes for Medical Devices in Australia (20)
More from Joe Hage
More from Joe Hage (12)
Recently uploaded
Recently uploaded (20)
TGA changes for Medical Devices in Australia
- 1. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com The Big Changes in Australia in Medical Devices Product Development and Market Access Down Under Dr Arthur Brandwood •Previous Director Devices Registration and Assessment at TGA and Director, TGA Biomaterials and Engineering Laboratories •Past National Chair and Chair Regulatory Expert Panel AusMedtech •Member of AHWP SG1 and Leader of Combination Products Task group •Adviser and trainer to multiple Asia Pacific regional regulators •Australian Delegation Leader to ISO TC 194 – Biocompatibility and Clinical Trials and ISO TC 150 – Implantable Devices •Past President Australian Society for Biomaterials •Visiting Professor in Biomedical Engineering, University of Sydney
- 2. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com BRANDWOOD:BIOMEDICAL securing your compliance Medical Devices and IVDs Asia Pacific Focus Global Perspective Highly Networked Highly Engaged
- 3. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com http://asiapacificdevicesummit.com/
- 4. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Why Australia? Deregulation Clinical Trials R&D Tax Concessions Employee Options Tax Concessions Trade with Asia
- 5. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
- 6. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com The Single Largest Manufacturing Sector Exporting from Australia to China is Therapeutics (Medical Devices and Pharmaceuticals) Australian Bureau of Statistics
- 7. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Health Spending - Australia
- 8. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Limited Resources: <100 in Devices Acts as both Competent Authority and Conformity Assessment Body Strong scientific culture – this was once a laboratory building!
- 9. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Therapeutic Goods Act 1989 http://www.tga.gov.au/industry/legislation.htm Chapter 1—Preliminary Chapter 2—Australian Register of Therapeutic Goods Chapter 3—Medicines and other therapeutic goods that are not medical devices Part 3-1—Standards Part 3-2—Registration and listing of therapeutic goods Part 3-3—Manufacturing of therapeutic goods Chapter 4—Medical devices Part 4-1—Introduction Part 4-2—Essential principles and medical device standards Part 4-3—Conformity assessment procedures Part 4-4—Conformity assessment certificates Part 4-5—Including medical devices in the Register Part 4-6—Suspension and cancellation from the Register Part 4-7—Exempting medical devices from inclusion in the Register Part 4-8—Obtaining information Part 4-9—Public notification and recovery of medical devices Part 4-10—Assessment fees Part 4-11—Offences and civil penalty provisions relating to medical devices Chapter 5—Advertising, counterfeit therapeutic goods and product tampering
- 10. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Therapeutic Goods (Medical Devices) Regulations 2002 Includes AIMDs and IVDs 5.7 Active implantable medical devices (1) An active implantable medical device is classified as Class AIMD. Four New Rules for IVDs
- 11. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Special Access Clinical Trials Authorised Prescriber Custom Made CTN CTX SAS B SAS A ARTG Inclusion Exempt Goods Personal Imports AIMD Act Implant III IIb I NO TGA assessment of safety MUST MEET safety and performance requirements Generally humanitarian exemptions or advance access to new technology pending completion of TGA regulatory assessment For Investigational use only – for research or to gather clinical data to support subsequent TGA assessment This is a unique Australian regulatory peculiarity – a person may import any device or medicine (except S8 poisons e.g. narcotics) for personal use at own risk These are single devices individually manufactured to clinical prescription for a named patient (e.g. dental crowns, orthotic braces) These are very low risk goods (e.g. hospital bedding, protective clothing, conventional toothpastes) These devices and IVDs are subject to TGA regulatory assessment which increases with higher numbered risk class These devices are NOT assessed by TGA and are EXEMPT from inclusion on ARTG – but they must still meet safety and performance regulations and are subject to postmarket monitoring IIa IVD 4 IVD 3 IVD 2 IVD 1 Australian Regulatory Requirements
- 12. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Sponsor – the Australian Authorized Representative Must be Australian company May be third party Provides manufacturer info to TGA on demand •Contractual arrangement with manufacturer BRANDWOOD BIOMEDICAL securing your compliance
- 13. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
- 14. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com TGA accepts CE certificates in lieu of Australian Certificates for most devices
- 15. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Fast Track Have Your Certificates Ready
- 16. BRANDWOOD BIOMEDICAL www.brandwoodbiomedical.com securing your compliance Manufacturer Sponsor TGA Determine AU Class Technical File Data Australian D.o.C CE Certification Accepted Manufacturer Evidence Sponsor Makes ARTG Application for Device Sponsor Submits To TGA e Assess e Assess ARTG Entry Application Audit
- 17. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Exclusions to the CE Fast Track Class III with integral medicine •Also requires TGA medicine assessment Class III with biological component •Includes recombinant products, blood products •Some low risk exceptions e.g. gelatine All Australian manufactured devices •Direct TGA assessment is mandatory for the locals •TGA may abridge assessment if device is CE marked
- 18. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
- 19. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com “As an important first step, the Government will enable Australian manufacturers of medical devices the option of using European Union certification in place of TGA certification. This will place Australian manufacturers on the same footing as overseas competitors.”
- 20. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Exclusions to the CE Fast Track Class III with integral medicine •Also requires TGA medicine assessment Class III with biological component •Includes recombinant products, blood products •Some low risk exceptions e.g. gelatine
- 21. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
- 22. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Multiple Reviews of TGA 3 Senate enquiries Auditor General Review HTA Review … TGA
- 23. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com It’s all about Confidence… TGA is undertaking Confidence Building with EC Notified Bodies −Shared Audits −Document reviews −Information Exchange Reduced Application audits for those in which TGA has Confidence
- 24. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Special Access Clinical Trials Authorised Prescriber Custom Made CTN CTX SAS B SAS A ARTG Inclusion Exempt Goods Personal Imports AIMD Act Implant III IIb I NO TGA assessment of safety MUST MEET safety and performance requirements Generally humanitarian exemptions or advance access to new technology pending completion of TGA regulatory assessment For Investigational use only – for research or to gather clinical data to support subsequent TGA assessment This is a unique Australian regulatory peculiarity – a person may import any device or medicine (except S8 poisons e.g. narcotics) for personal use at own risk These are single devices individually manufactured to clinical prescription for a named patient (e.g. dental crowns, orthotic braces) These are very low risk goods (e.g. hospital bedding, protective clothing, conventional toothpastes) These devices and IVDs are subject to TGA regulatory assessment which increases with higher numbered risk class These devices are NOT assessed by TGA and are EXEMPT from inclusion on ARTG – but they must still meet safety and performance regulations and are subject to postmarket monitoring IIa IVD 4 IVD 3 IVD 2 IVD 1 Australian Regulatory Requirements Clinical Trial Notification •Ethics Committee assessment of the protocol and oversight of trial •TGA may audit the trial •Nominal Fees •Notification only to TGA •All devices have been done this way to date
- 25. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com National Controls http://www.australianclinicaltrials.gov.au/node/30
- 26. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Lower Costs
- 27. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
- 28. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com “…it's CASH, paid quarterly, not a tax credit” “Note the difference between the rebate and the tax rate - effectively the rebate is a subsidy way higher than the tax deductibility of these expenses”
- 29. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Free Money – from the Tax Man The Australian R&D Tax Incentive 45% Refundable Offset −Non refundable for firms >$20M turnover −For small firms – paid as refund, quarterly Eligible Entities −Australian companies −Foreign companies in countries with double tax agreement which have permanent establishment in Australia https://www.ato.gov.au/Business/Research-and-development-tax-incentive/
- 30. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
- 31. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com The R&D challenge… Clinical Challenge •Bowel Preps available in Australia not effective •Require significant investment to develop data •High patient population requires significant sample size Clinical Trial Required •Multicentre •Randomised •CRA Audited •300 Patients •$ 1 Million budget ANZ operations didn’t have budget to support
- 32. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com R&D Tax Incentive Given ANZ subsidiary, local profits 3-4% Provided potential for legitimate cost savings and capability Needed to demonstrate that proposed trial outcomes had not already been demonstrated ie: True R&D
- 33. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Employee Share Options July 2015 commencement Defer tax until exercise of options Maximum time for deferral 15 years Standardised documentation for establishment and maintenance of ESS.
- 34. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Start-up Concession for ESS Unlisted Co. / Aggregate Turnover <$50M / Inc. < 10 Years Tax exempt first $1,000 for employees earning <$180,000 Shares at discount of up to 15% with no tax liability for discount −Discounted portion is exempt from CGT at time of sale Shares must be held at least 3 years
- 35. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Why Australia? Deregulation Clinical Trials R&D Tax Concessions Employee Options Tax Concessions Trade with Asia
- 36. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
- 37. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Regulatory Trends in Asia Pacific 2015 ASEAN MDD Commences 2014 ASEAN harmonizes IVD registration format New Provisions in China Japan PMDL Malaysia Regulations 2013 China SFDA becomes CFDA 2011 India Medical Devices 2010 HK Medical Devices Registrations 2009 Korea High-risk IVD Tougher regs 2008 HK IVD Voluntary Product Listing Singapore Mandatory Registration 2007 Major Regulation Change in China 2006 Malaysia Voluntary Product Listing 2005 Japan PAL 2004 Hong Kong Medical Device Registration –excludes IVDs Singapore Voluntary Listing 2002 China Mandatory Product Registration
- 38. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com http://asiapacificdevicesummit.com/
- 39. BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com Let’s talk! TGA Submissions Australian Sponsor Service −and others including China Regulatory Strategy Risk Analysis and Standards Compliance Quality Systems Clinical Trials Postmarket Compliance Reimbursement Regulatory Intelligence Training Contact us for a free no- obligation consultation and quote +61 2 9906 2984 help@brandwoodbiomedical.com www.brandwoodbiomedical.com Brandwood Biomedical has offices in Sydney, Wellington and Beijing and offers specialist expertise throughout the Asia Pacific