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
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
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
http://asiapacificdevicesummit.com/
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
Why Australia?
Deregulation
Clinical Trials
R&D Tax Concessions
Employee Options Tax Concessions
Trade with Asia
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
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
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Health Spending - Australia
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Limited Resources: <100 in Devices
Acts as both Competent Authority
and Conformity Assessment Body
Strong scientific culture – this was once a
laboratory building!
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
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
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
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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
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
TGA accepts CE certificates
in lieu of Australian Certificates
for most devices
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
Fast Track
Have Your Certificates Ready
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
TGA Sponsor Manufacturer
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
Assess e
Assess ARTG Entry e Application
Audit
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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
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
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.”
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
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
Multiple Reviews of TGA
3 Senate enquiries
Auditor General Review
HTA Review
…
TGA
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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
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
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National Controls
http://www.australianclinicaltrials.gov.au/node/30
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Lower Costs
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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”
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/
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
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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
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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
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.
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
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
Why Australia?
Deregulation
Clinical Trials
R&D Tax Concessions
Employee Options Tax Concessions
Trade with Asia
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
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
BRANDWOOD BIOMEDICAL securing your compliance www.brandwoodbiomedical.com
http://asiapacificdevicesummit.com/
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
www.brandwoodbiomedical.com
Brandwood Biomedical has offices in Sydney, Wellington and Beijing and offers specialist expertise throughout the
Asia Pacific